[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-small-cell-lung-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-small-cell-lung-cancer":196},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,696,0,25,[9,41,61,81,100,125,145,181,211,238,259,302,326,345,365,382,405,424,443,466,486,522,556,577,613],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100635565","phase-3-a-clinical-trial-of-calderasib-mk-1084-and-durvalumab-in-people-with-non-small-cell-lung-cancer-mk-1084-015kandlelit-015-100635565",false,"NCT07554339","A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015\u002FKANDLELIT-015)","A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Study of MK-1084 Plus Durvalumab Versus Placebo Plus Durvalumab in Participants With Locally Advanced, Unresected KRAS G12C-Mutant Non-Small Cell Lung Cancer Without Disease Progression Following Definitive Platinum-Based Chemoradiotherapy (KANDLELIT-015)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has a histological or cytological diagnosis of locally advanced, unresected Stage II (node-positive) to III non-small cell lung cancer (NSCLC) with predominantly nonsquamous histology.\n* Has completed definitive platinum-based concurrent chemoradiotherapy (CCRT) prior to enrollment, without disease progression.\n* Has provided a tumor tissue sample for central laboratory testing of Kirsten rat sarcoma G12C (KRAS G12C) status, programmed cell death ligand 1 (PD-L1) status, and biomarker research.\n* Tumor tissue sample has a demonstrated presence of KRAS G12C mutation and an evaluable PD-L1 status result.\n* If human immunodeficiency virus (HIV)-infected, has well-controlled HIV on antiretroviral therapy (ART).\n* If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral therapy.\n* If has a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load.\n* Has a body weight ≥35 kg.\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has a diagnosis of small cell lung cancer or mixed tumors with small cell elements.\n* Has a gastrointestinal disorder affecting absorption or is unable to swallow orally administered medication.\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease.\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.\n* Is HIV-infected with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease.\n* Has received prior treatment (other than definitive CCRT) for NSCLC.\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n* Has an active autoimmune disease that has required systemic treatment in the past 2 years.\n* Has a history of, or has current, (noninfectious) pneumonitis\u002Finterstitial lung disease that required\u002Frequires steroids.\n* Has an active infection requiring systemic therapy.\n* Has a history of stem cell\u002Fsolid organ transplant.\n* Has not adequately recovered from major surgery or has ongoing surgical complications.","ALL","18 Years",{"count":20,"type":21},310,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Researchers are looking for new ways to treat locally advanced non-small cell lung cancer (NSCLC) that is unresected and has a gene mutation called KRAS G12C. Researchers want to learn if calderasib (MK-1084) can be given with durvalumab, an immunotherapy, to treat NSCLC after chemotherapy and radiation therapy.\n\nThe goal of this trial is to learn if participants who receive calderasib and durvalumab live longer without the cancer growing or spreading compared to participants who receive placebo and durvalumab.",[27],"Non-small Cell Lung Cancer","RECRUITING","2026-08-20",{"date":31,"type":32},"2026-08-21","ACTUAL",{"date":34,"type":32},"2026-06-18",{"date":36,"type":21},"2037-08-17",{"name":38,"class":39},"Merck Sharp & Dohme LLC","INDUSTRY",59,{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":54,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":60},"100632414","a-clinical-trial-of-adjuvant-intismeran-v940-with-or-without-pembrolizumab-coformulated-with-berahyaluronidase-alfa-mk-3475a-in-high-risk-stage-i-non-small-cell-lung-cancer-v940-014-100632414","NCT07513376","A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I Non-Small Cell Lung Cancer (V940-014)","A Phase 3, Randomized, Placebo-Controlled Study of Adjuvant Intismeran Autogene Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) or Intismeran Autogene Monotherapy Versus Placebo in Participants With Completely Resected High-Risk Stage I Non-Small Cell Lung Cancer (INTerpath-014)","INTerpath-014","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has a histological diagnosis of pathological Stage I (tumor ≤4 cm) non-small cell lung cancer (NSCLC) per American Joint Committee on Cancer (AJCC) 9th Edition with at least 1of the following high-risk pathologic features as assessed locally: tumor size \\>2cm, visceral pleural invasion, lymphovascular invasion, or high-grade histology\n* Has undergone a complete surgical resection of the primary NSCLC\n* Has not received other prior treatment outside of definitive surgery (including but not limited to chemotherapy, immunotherapy, targeted therapy, or radiotherapy) for their current Stage I NSCLC\n* Has provided a tissue sample from recent surgery along with the required blood sample\n* Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART)\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has diagnosis of any 1 of the following: small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, neuroendocrine tumor with large cell components, sarcomatoid carcinoma, or two synchronous primary NSCLCs\n* Has any clinically significant cardiovascular disease within 12 months before randomization, including a history of coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI), valvular heart disease requiring surgical intervention, New York Heart Association Class III-IV heart failure, unstable angina, myocardial infarction (MI), pulmonary hypertension, cardiovascular accident (CVA), or hemodynamically unstable cardiac arrhythmia\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has active autoimmune disease that has required systemic treatment in the past 2 years. Hormonal supplementation (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed\n* Has history of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease\n* Has active infection requiring systemic therapy other than those permitted in protocol\n* Has history of stem cell\u002Fsolid organ transplant\n* Participants who have not adequately recovered from major surgery or have ongoing surgical complications",{"count":50,"type":21},876,[24],"Researchers are looking for new ways to treat high-risk, localized non-small cell lung cancer (NSCLC) that has been removed with surgery.\n\nPeople with high-risk, localized NSCLC are often treated with surgery. Researchers want to learn if participants can receive 1 or 2 trial treatments to help prevent NSCLC from coming back after surgery. One trial medicine is intismeran (also called V940\u002FmRNA-4157) and the other is subcutaneous pembrolizumab (also called SC pembrolizumab and MK-3475A). Intismeran is designed to help a person's immune system attack their specific cancer. SC pembrolizumab is an immunotherapy treatment which helps the immune system fight cancer.\n\nThe main purpose of this study is to evaluate whether adjuvant intismeran autogene (V940) in combination with SC pembrolizumab and berahyaluronidase alfa (MK-3475A) or intismeran monotherapy improves disease-free survival (DFS) compared with placebo in participants with completely resected high-risk Stage I NSCLC.",[27],{"date":31,"type":32},{"date":56,"type":32},"2026-05-04",{"date":58,"type":21},"2038-05-11",{"name":38,"class":39},68,{"id":62,"slug":63,"hasResults":12,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":4,"eligibilityCriteria":67,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":22,"phases":70,"briefSummary":71,"conditions":72,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":73,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100607987","phase-3-beamion-lung-3-adjuvant-zongertinib-vs-standard-treatment-in-people-with-completely-resected-stage-ii-iiib-nsclc-harboring-activating-her2-tkd-mutations-100607987","NCT07195695","Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations","Beamion LUNG-3: A Randomized, Controlled, Multi-center Trial Evaluating Zongertinib as an Adjuvant Monotherapy Compared With Standard of Care in Patients With Early-stage, Resectable Non-small Cell Lung Cancer (Stage II-IIIB) Harboring Tyrosine Kinase Domain Activating HER2 Mutations","Inclusion criteria:\n\n1. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial\n2. Patients must be ≥18 years old or over the legal age of consent in their country\n3. Male or female patients. Women of childbearing potential (WOCBP) must be ready and able to use dual highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information and in the study protocol\n4. HER2 mutation: Documented Tyrosine kinase domain (TKD) activating Human epidermal growth factor receptor 2 (HER2) mutations\n5. Histology and tumor sample: Histologically confirmed diagnosis of primary NSCLC\n6. An archival tumor tissue sample must be submitted to the central laboratory after inclusion of the patient to retrospectively confirm the HER2 status\n7. Staging: Pretherapeutic classification not exceeding Stage IIIB\n8. Performance status and organ function:\n\n   * Eastern Cooperative Oncology Group (ECOG) score of 0 or 1\n   * Adequate organ function based on laboratory values Further inclusion criteria apply.\n\nExclusion criteria:\n\n1. Diagnosis of NSCLC with mixed histology\u002Fpositive neuroendocrine markers (synaptophysin\u002FCD56)\n2. Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization\n3. Treatment with radiation therapy for primary NSCLC\n4. Co-occurring actionable mutation with approved targeted therapy (e.g. Epidermal growth factor receptor (EGFR) or Anaplastic lymphoma kinase (ALK))\n5. Any investigational drug within 5 half-lives of the compound or any of its related material, if known\n6. History or presence of\n\n   * Active or known pre-existing or history of non-infectious interstitial lung disease\u002Fpneumonitis\n   * Active infectious disease requiring systemic therapy\n   * Uncontrolled gastrointestinal disorders affecting drug intake\u002Fabsorption\n   * Previous or concomitant malignancies within the last 3 years, except certain effectively treated cancers\n   * Significant and\u002For uncontrolled cardiovascular abnormalities, QT interval corrected for heart rate by Fridericia formula (QTcF) \\>470 msec, or ejection fraction \\\u003C50% Further exclusion criteria apply.",{"count":69,"type":21},400,[24],"Beamion LUNG-3 study evaluates whether zongertinib, an oral HER2-targeted treatment, can improve outcomes compared with standard adjuvant treatment in adults with completely resected Stage II-IIIB non-small cell lung cancer (NSCLC) whose tumors have activating HER2 tyrosine kinase domain (TKD) mutations. Eligible participants must have undergone curative-intent surgery and received guideline-appropriate perioperative systemic therapy, either neoadjuvant platinum-based chemotherapy with or without immunotherapy, or adjuvant platinum-based chemotherapy.\n\nParticipants are randomized 1:1 to receive zongertinib or standard of care, which may consist of approved adjuvant immunotherapy or active surveillance, based on local practice guidelines. The main purpose of the study is to determine whether zongertinib can prolong disease-free survival compared to standard treatment. Safety and patient-reported outcomes are also assessed.",[27],{"date":31,"type":32},{"date":75,"type":32},"2026-01-16",{"date":77,"type":21},"2036-09-02",{"name":79,"class":39},"Boehringer Ingelheim",202,{"id":82,"slug":83,"hasResults":12,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":93,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},"100607568","phase-3-a-clinical-study-of-calderasib-mk-1084-and-other-treatments-for-participants-with-non-small-cell-lung-cancer-mk-1084-007kandlelit-007-100607568","NCT07190248","A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007\u002FKANDLELIT-007)","A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084 in Combination With Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus MK-3475A in Combination With Pemetrexed\u002FPlatinum (Carboplatin or Cisplatin) Chemotherapy as First-line Treatment of Participants With KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC (KANDLELIT-007)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has nonsquamous NSCLC (Stage IIIB, Stage IIIC) not eligible for curative resection or chemoradiation or Stage IV: M1a, M1b, or M1c\n* If human immunodeficiency virus (HIV) positive, must have well controlled HIV on antiretroviral therapy (ART)\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea)\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease\n* Has a gastrointestinal disorder affecting absorption\n* Is HIV positive and has a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has received prior systemic anticancer therapy for their advanced or metastatic NSCLC\n* Has known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n* Has active autoimmune disease that has required systemic treatment in the past 2 years\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease\n* Has active infection requiring systemic therapy except those specified by protocol\n* Has history of stem cell\u002Fsolid organ transplant\n* Has not adequately recovered from major surgery or has ongoing surgical complications",{"count":89,"type":21},675,[24],"Researchers want to learn if the study medicines calderasib and subcutaneous (SC) pembrolizumab can be used to treat non-small cell lung cancer (NSCLC) when given together. Calderasib is a targeted therapy for the KRAS G12C mutation.\n\nThe goal of this study is to learn if people who receive calderasib with SC pembrolizumab live longer without the cancer growing or spreading than in people who receive SC pembrolizumab with chemotherapy.",[27],{"date":31,"type":32},{"date":95,"type":32},"2025-10-08",{"date":97,"type":21},"2032-08-06",{"name":38,"class":39},200,{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":22,"phases":110,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":118,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},"100540076","phase-3-a-study-to-assess-efficacy-and-safety-of-pembrolizumab-with-or-without-sacituzumab-tirumotecan-mk--2870-in-adult-participants-with-resectable-non-small-cell-lung-cancer-nsclc-not-achieving-pathological-complete-response-pcr-mk-2870-019-100540076","NCT06312137","A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019)","A Phase 3 Randomized Open-Label Study of Adjuvant Pembrolizumab With or Without MK-2870 in Participants With Resectable Stage II to IIIB (N2) NSCLC Not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy Followed by Surgery","TroFuse-019","The key inclusion and exclusion criteria include but are not limited to the following:\n\nInclusion Criteria:\n\n* Has histological or cytological confirmation of squamous or nonsquamous non-small cell lung cancer (NSCLC), resectable clinical Stage II, IIIA or IIIB (with nodal involvement \\[N2\\]) per AJCC eighth edition guidelines\n* Has confirmation that either epidermal growth factor receptor (EGFR)-directed or anaplastic lymphoma kinase (ALK)-directed therapy is not indicated as primary therapy\n* Is able to undergo surgery based on opinion of investigator after consultation with surgeon\n* Is able to receive neoadjuvant pembrolizumab and platinum-based doublet chemotherapy\n* Applies to screening for the adjuvant period only, before randomization: Has not achieved pathological complete response (pCR) at surgery by local review of pathology.\n* Applies to screening for the adjuvant period only, before randomization: Tumor tissue sample from surgical resection has been provided for determination of programmed cell death ligand 1 (PD-L1) and trophoblast cell surface antigen 2 (TROP2) status by central vendor before randomization into the adjuvant period\n* Applies to screening for the adjuvant period only, before randomization: Confirmed to be disease-free based on re-baseline radiological assessment as documented by contrast enhanced chest\u002Fabdomen\u002Fpelvis computed tomography (CT) (or magnetic resonance imaging (MRI)) within 28 days before randomization\n* Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load at screening\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at least 4 weeks before the start of study intervention\n\nExclusion Criteria:\n\n* Has one of the following tumor locations\u002Ftypes:\n\n  * NSCLC involving the superior sulcus\n  * Large cell neuro-endocrine cancer (LCNEC)\n  * Sarcomatoid tumor\n  * Diagnosis of SCLC or, for mixed tumors, presence of small cell elements\n* Has Grade ≥2 peripheral neuropathy\n* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or severe corneal disease that prevents\u002Fdelays corneal healing\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QT corrected for heart rate by Fridericia's cube root formula (QTcF) interval to \\>480 ms, and\u002For other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention\n* Has received prior neoadjuvant therapy for their current NSCLC diagnosis\n* Has received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention\n* Has received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed\n* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication\n* Has a known additional malignancy that is progressing or has required active treatment within the past 5 years\n* Has an active autoimmune disease that has required systemic treatment in the past 2 years\n* Has a history of (noninfectious) interstitial lung disease (ILD)\u002Fpneumonitis, has current ILD\u002Fpneumonitis, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at screening\n* Has an active infection requiring systemic therapy\n* Is an HIV-infected participant with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has a concurrent active Hepatitis B (defined as HBsAg positive and\u002For detectable HBV deoxyribonucleic acid (DNA)) and Hepatitis C virus (defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection\n* Has a history of allogeneic tissue\u002Fsolid organ transplant\n* Has not adequately recovered from major surgery or have ongoing surgical complications\n* Severe hypersensitivity (≥Grade 3) to study intervention, any of its excipients, and\u002For to another biologic therapy",{"count":109,"type":21},780,[24],"This study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery is effective in treating NSCLC for participants not achieving pathological complete response. The primary hypothesis of this study is sacituzumab tirumotecan plus pembrolizumab is superior to pembrolizumab monotherapy with respect to disease free survival (DFS) as assessed by blinded independent central review (BICR).",[113],"Non Small Cell Lung Cancer",[115,116,117],"Carcinoma","Lung cancer","Non-small cell lung cancer",{"date":31,"type":32},{"date":120,"type":32},"2024-04-03",{"date":122,"type":21},"2034-10-23",{"name":38,"class":39},268,{"id":126,"slug":127,"hasResults":12,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":22,"phases":135,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":138,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},"100522066","phase-3-a-study-of-intismeran-autogene-v940-plus-pembrolizumab-mk-3475-versus-placebo-plus-pembrolizumab-in-participants-with-non-small-cell-lung-cancer-v940-002-100522066","NCT06077760","A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)","A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With Resected Stage II, IIIA, IIIB (N2) Non-small Cell Lung Cancer (INTerpath-002)","INTerpath-002","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has undergone margin negative, completely resected non-small cell lung cancer (NSCLC), and has pathological Stage II, IIIA, IIIB (N2) squamous or nonsquamous tumor, node, metastasis (TNM) staging per American Joint Committee on Cancer (AJCC) Eighth Edition guidelines.\n* Has no evidence of disease before randomization.\n* Has received at least one dose of adjuvant treatment with standard of care platinum doublet chemotherapy.\n* No more than 24 weeks have elapsed between surgical resection of curative intent and the first dose of pembrolizumab.\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Diagnosis of small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, or has a neuroendocrine tumor with large cell components or a sarcomatoid carcinoma.\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease.\n* Received prior neoadjuvant therapy for their current NSCLC diagnosis.\n* Received or is a candidate to receive radiotherapy for their current NSCLC diagnosis.\n* Received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-PD-ligand 1 (L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor.\n* Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.\n* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.\n* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication.\n* Known additional malignancy that is progressing or has required active treatment within the past 5 years.\n* Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed.\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n* Active infection requiring systemic therapy.",{"count":134,"type":21},868,[24],"The goal of this study is to evaluate intismeran autogene plus pembrolizumab versus placebo plus pembrolizumab for the adjuvant treatment of margin negative, completely resected Stage II, IIIA, IIIB (with nodal involvement \\[N2\\]) non-small cell lung cancer (NSCLC). The primary hypothesis is that intismeran autogene plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator.",[27],{"date":31,"type":32},{"date":140,"type":32},"2023-12-06",{"date":142,"type":21},"2035-12-21",{"name":38,"class":39},229,{"id":146,"slug":147,"hasResults":12,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":153,"enrollmentInfo":154,"targetDuration":4,"studyType":22,"phases":156,"briefSummary":158,"conditions":159,"keywords":160,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":173,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":180},"100443987","phase-2-neoadjuvant-and-adjuvant-treatment-in-resectable-non-small-cell-lung-cancer-100443987","NCT05061550","Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer","A Phase II, Open-label, Multicentre, Randomised Study of Neoadjuvant and Adjuvant Treatment in Patients With Resectable, Early-stage (II to IIIB) Non-small Cell Lung Cancer (NeoCOAST-2)","NeoCOAST-2","Inclusion Criteria:\n\n* Newly diagnosed NSCLC patients with resectable disease (Stage IIA to Stage IIIB).\n* WHO or Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate organ and bone marrow function.\n* Provision of tumour samples (newly acquired or archival tumour tissue \\[≤ 6 months old\\]) to confirm Programmed death-ligand 1 (PD-L1) status, epidermal growth factor receptor (EGFR), or anaplastic lymphoma kinase (ALK) status.\n* Adequate pulmonary function.\n\nExclusion Criteria:\n\n* Participants with sensitising EGFR mutations or ALK translocations.\n* Participants with baseline PD-L1 expression status \\\u003C1% (Arms 6 and 7 only).\n* Active or prior documented autoimmune or inflammatory disorders.\n* Uncontrolled intercurrent illness, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active bleeding diseases, serious chronic gastrointestinal conditions associated with diarrhoea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement.\n* History of another primary malignancy.\n* Participants with small-cell lung cancer or mixed small-cell lung cancer.\n* History of active primary immunodeficiency.\n* History of non-infectious interstitial lung disease (ILD) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or has suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at screening.\n* Participants who have preoperative radiotherapy treatment as part of their care plan.\n* Participants who require or may require pneumonectomy, segmentectomies, or wedge resections, as assessed by their surgeon at baseline, to obtain potentially curative resection of primary tumour.\n* QTcF (QT interval corrected by Fridericia's formula) interval ≥ 470 ms.\n* Any medical contraindication to treatment with chemotherapy as listed in the local labelling.\n* Participants with moderate or severe cardiovascular disease.\n* Any concurrent chemotherapy, investigational product, biologic, or hormonal therapy for cancer treatment.\n* Receipt of live attenuated vaccine within 30 days prior to the first dose of study interventions.\n* Prior exposure to approved or investigational immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-TIGIT (T cell immunoreceptor with Ig and ITIM domains), anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies. Participants who received agents targeting the adenosine pathway, anti-NKG2A, anti-HLA-E agents, and anti-LIF agents are also excluded. Participants who have received previous treatment with a TROP2 targeting ADC or with another ADC containing a chemotherapy agent that inhibits TOP1 activity are also excluded.\n* Current or prior use of immunosuppressive medication within 14 days before the first dose of study interventions.\n* Active or uncontrolled infections including HBA, HBV, HCV, and HIV.","95 Years",{"count":155,"type":21},630,[157],"PHASE2","The study is intended to assess the safety and efficacy of perioperative treatment with Durvalumab in combination with Oleclumab, Monalizumab, or AZD0171 and platinum doublet chemotherapy (CTX); or Volrustomig or Rilvegostomig in combination with CTX; or Datopotamab deruxtecan (Dato-DXd) in combination with Durvalumab or Rilvegostomig and single agent platinum chemotherapy in participants with resectable, early-stage non-small cell lung cancer.",[27],[161,162,163,164,165,166,167,168,169,170,171,172],"Lung Cancer","early-stage","Durvalumab","Oleclumab","Monalizumab","AZD0171","Datopotamab Deruxtecan","Neoadjuvant","Adjuvant","Chemotherapy","Volrustomig","Rilvegostomig",{"date":31,"type":32},{"date":175,"type":32},"2022-04-14",{"date":177,"type":21},"2030-05-28",{"name":179,"class":39},"AstraZeneca",97,{"id":182,"slug":183,"hasResults":12,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":189,"enrollmentInfo":190,"targetDuration":4,"studyType":22,"phases":192,"briefSummary":194,"conditions":195,"keywords":197,"overallStatus":201,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":4},"100652805","septum-guided-segmentectomy-for-2-3-cm-clinical-stage-ia3-peripheral-non-small-cell-lung-cancer-100652805","NCT07780591","Septum-guided Segmentectomy for 2-3 cm Clinical Stage IA3 Peripheral Non-Small Cell Lung Cancer","Efficacy and Safety of Septum-guided Segmentectomy for 2-3 cm Clinical Stage IA3 Peripheral Non-Small Cell Lung Cancer: A Single-Center, Prospective, Single-Arm Clinical Trial","SGS2606","Inclusion Criteria:\n\n* Age 18 to 80 years, male or female.\n* Clinical stage IA3 non-small cell lung cancer according to the International Association for the Study of Lung Cancer 9th edition tumor, node, metastasis classification; clinical T1cN0M0; tumor maximum diameter \\>2 cm and \\\u003C=3 cm on imaging evaluation.\n* Consolidation-to-tumor ratio (CTR) \\>0.5 and \\\u003C=1 on thin-section computed tomography.\n* Peripheral tumor judged by the investigator to be amenable to curative segmentectomy or lobectomy, with an anticipated ability to achieve the protocol-specified surgical margin.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.\n* Preoperative pulmonary function adequate for surgery, with forced expiratory volume in 1 second \\>=60% predicted and single-breath diffusing capacity of the lung for carbon monoxide \\>=60% predicted, unless otherwise documented after multidisciplinary evaluation.\n* Willing to undergo intraoperative lymph node frozen-section biopsy to confirm node-negative status and understands that a positive frozen-section result will lead to conversion to lobectomy as standard treatment and exclusion from the primary efficacy analysis.\n* Able to understand the study and voluntarily sign written informed consent.\n\nExclusion Criteria:\n\n* Intraoperative lymph node frozen-section biopsy confirms N1 or N2 metastasis, or preoperative endobronchial ultrasound-guided biopsy or mediastinoscopy confirms N1, N2, or N3 metastasis, pleural dissemination, or distant metastasis. Patients with positive intraoperative frozen-section results will be converted to lobectomy plus systematic lymph node dissection as standard treatment and recorded as screen failures.\n* Multiple primary lung cancers or multiple pulmonary nodules requiring concurrent resection outside the protocol-defined scope that would affect assessment of the primary endpoint.\n* Prior ipsilateral lobectomy or segmentectomy, or severe pleural adhesions making the study procedure unevaluable.\n* Other active malignancy within 5 years, except cured low-risk tumors.\n* Severe cardiac, cerebral, hepatic, renal, or other disease that would preclude general anesthesia or curative lung cancer surgery.\n* Pregnant or breastfeeding women.\n* Any other condition that, in the investigator's opinion, makes the participant unsuitable for this study.","80 Years",{"count":191,"type":21},100,[193],"NA","This is a single-center, prospective, single-arm, open-label clinical trial evaluating the efficacy and safety of septum-guided segmentectomy in patients with 2-3 cm clinical stage IA3 peripheral non-small cell lung cancer (NSCLC) with a consolidation-to-tumor ratio (CTR) greater than 0.5 and up to 1.0. All eligible participants will undergo planned septum-guided anatomical segmentectomy or combined segmentectomy after intraoperative frozen-section confirmation of node-negative (N0) lymph node status. The primary endpoint is 3-year recurrence-free survival (RFS).",[196],"Non-Small Cell Lung Cancer",[198,199,200],"segmentectomy","clinical stage IA3","peripheral NSCLC","NOT_YET_RECRUITING","2026-08-19",{"date":31,"type":32},{"date":205,"type":21},"2026-08",{"date":207,"type":21},"2034-08",{"name":209,"class":210},"Shanghai Chest Hospital","OTHER",{"id":212,"slug":213,"hasResults":12,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":218,"targetDuration":4,"studyType":22,"phases":220,"briefSummary":221,"conditions":222,"keywords":223,"overallStatus":201,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":229,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":237},"100652710","phase-2-optimise-lung-sabr-100652710","NCT07777614","OPTIMISE Lung SABR","OPTIMISation of pEripheral Lung Stereotactic Ablative Body Radiotherapy, a Prospective Independent Evaluation of 3 Fraction and 5 Fraction SABR Regimens (OPTIMISE Lung SABR)","Inclusion Criteria:\n\n1. Written informed consent obtained prior to any study-specific procedures.\n2. ≥ 18 years of age.\n3. Life expectancy \\>6 months.\n4. ECOG (Eastern Cooperative Oncology Group) performance status of 0-2.\n5. Histological diagnosis (biopsy or cytology) or radiological diagnosis (tumour which meets definition of 'measurable' per RECIST criteria and eligible for local ablative therapy per multi-disciplinary team (MDT) recommendations) of either:\n\n   (i) Primary Non-Small Cell Lung Cancer (squamous cell carcinoma, adenocarcinoma, large cell): T1-T2 N0 M0 tumour (AJCC 8th edition) and selected T3 and T4 N0M0 which has only one lesion (a co-existing lesion unlikely to interfere with treatment or assessment of outcomes is permitted) to be treated for the purpose of the study OR (ii) Single pulmonary oligometastatic lesion to be treated for the purpose of the study.\n\n   (Note: for (i) and (ii), a co-existing lesion(s) unlikely to interfere with treatment or assessment of outcomes is (are) permitted).\n6. Patients with peripherally located tumours, defined as tumours not fulfilling the UK 2022 SABR Consortium Consensus optimal 3 fraction constraints for Chest wall (0.1 cc \\\u003C36.9 Gy) or (30 cc \\\u003C 30 Gy), with standard Planning Target Volume (PTV) coverage due to the proximity of their tumour to the chest wall , but which are predicted to meet the CTRIAL-IE 24-15 OPTIMISE Lung SABR Study dose volume constraints with dose escalation optimised to the Gross Tumour Volume (GTV).\n7. Inoperable (as per MDT) or patient refuses surgery.\n8. People of childbearing potential must not be pregnant or lactating and must be prepared to take adequate contraception methods during treatment. People whose partners are of child-bearing potential must be prepared to take adequate contraception methods during treatment.\n9. Absence of psychological, familial, sociological, or geographical condition, or psychiatric illness\u002Fsocial situation potentially hampering compliance with the study protocol and follow-up schedule\n\nExclusion Criteria:\n\n1. Known co-existing or prior malignancy within the last 5 years (except for adequately treated basal cell carcinoma which is likely to interfere with treatment or assessment of outcomes.\n2. Evidence of regional (nodal) or distant metastases or metastatic pleural effusion for patients with primary NSCLC.\n3. Malignant spinal canal involvement.\n4. Patients with syndromes or conditions associated with increased radiosensitivity.\n5. Idiopathic pulmonary fibrosis \u002F usual interstitial pneumonia.\n6. Chemotherapy and\u002For other targeted therapy administered within 3 months prior to study radiotherapy (RT) or planned for \\\u003C6 weeks following RT for patients with primary NSCLC, or within 1 week prior to study RT or planned within 1 week following RT for patients with an oligometastatic lesion.\n7. Any previous RT to the thorax or mediastinum (excluding previous breast or Chest Wall RT) which is likely to interfere with treatment or assessment of outcomes.\n8. Any tumour not clinically definable on the treatment planning CT scan (e.g. surrounding consolidation or atelectasis).\n9. Patients unable to undergo 4-Dimensional Computed Tomography (4DCT scan).\n10. Uncontrolled intercurrent illness that is likely to interfere with treatment or assessment of outcomes.\n11. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study, or if it is felt by the research\u002F medical team that the patient may not be able to comply with the protocol.",{"count":219,"type":21},208,[157],"This study is a phase II multi-centre, randomised study independently evaluating five fraction Image-Guided Stereotactic Ablative Radiotherapy (IG-SABR) and three fraction IG-SABR for patients with a peripherally located T1-T2 and selected T3 and T4 lung tumours, or a peripherally located single pulmonary oligometastatic lesion.",[113],[116,117,224,225,226,227,228],"Peripheral","Stereotactic Ablative Body Radiotherapy (SABR)","Radiotherapy","Oligometastatic cancer","Single lung lesion",{"date":29,"type":32},{"date":231,"type":21},"2026-10",{"date":233,"type":21},"2035-06",{"name":235,"class":236},"Cancer Trials Ireland","NETWORK",1,{"id":239,"slug":240,"hasResults":12,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":244,"eligibilityCriteria":245,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":22,"phases":248,"briefSummary":249,"conditions":250,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":251,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":258},"100641898","a-phase-2-study-of-vs-7375-in-patients-with-kras-g12d-mutated-non-small-cell-lung-cancer-100641898","NCT07659782","A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Non-Small Cell Lung Cancer","A Phase 2, Open-label Study of VS-7375, an Oral KRAS G12D (ON\u002FOFF) Inhibitor, in Patients With Previously Treated, Advanced KRAS G12D-Mutated Non-Small Cell Lung Cancer (TARGET-D 202)","TARGET-D 202","Inclusion Criteria:\n\n* Histopathology confirmed unresectable locally advanced or metastatic NSCLC\n* Measurable disease per RECIST 1.1\n* Local testing confirmed KRAS G12D mutation (tissue required for confirmatory central testing)\n* ECOG PS=0 or 1\n* Adequate organ function\n* Received prior treatment with a platinum-based chemotherapy regimen and an immune checkpoint inhibitor in the advanced, non-resectable setting.\n* Have documented disease progression during or following their most recent prior line of therapy.\n\nPatients with 2L\u002F3L on stable or preferred dose:\n\n* Received at least 1 and no more than 2 prior systemic lines of therapy for advanced (in the unresectable locally advanced or metastatic setting) NSCLC.\n\nPatients with 2L-4L with brain metastases:\n\n* Received at least 1 and no more than 3 prior systemic lines of therapy for advanced (in the unresectable locally advanced or metastatic setting) NSCLC.\n* Have asymptomatic and untreated brain metastases\n* At least 1 untreated measurable brain lesion per mRECIST v1.1 with a long axis ≥ 0.5 cm and ≤ 3 cm.\n\nExclusion Criteria:\n\n* Have any other documented co-existing common RAS mutation(s)\n* Prior anti-cancer Tx within 4 weeks or drug-specific timeline within first treatment dose, whichever shorter\n* Major surgery within 4 weeks of first treatment dose\n* Radiation therapy (RT) within 1 week of first treatment dose\n* History of drug-induced Interstitial Lung Disease\n* Receipt of prior direct RAS inhibitor\n* Untreated or symptomatic CNS metastasis\n* Receipt of strong CYP3A4 inhibitor\u002Finducer or CYP3A4 sensitive substrates with narrow therapeutic index within 14 days or drug-specific timeline within first treatment dose, whichever is shorter\n* Receipt of PPI or H2 blocker within 5 days\n* Inability to swallow oral medication\n* Other protocol-defined inclusion\u002Fexclusion criteria may apply",{"count":247,"type":21},105,[157],"This study will assess the safety and efficacy of VS-7375 alone and in combination with cetuximab in patients with metastatic KRAS G12D - mutated Non-Small Cell Lung Cancer",[196],{"date":29,"type":32},{"date":253,"type":32},"2026-07-22",{"date":255,"type":21},"2028-12",{"name":257,"class":39},"Verastem, Inc.",7,{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":266,"enrollmentInfo":267,"targetDuration":4,"studyType":22,"phases":269,"briefSummary":271,"conditions":272,"keywords":284,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":294,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":301},"100639777","phase-1-a-first-in-human-study-of-hh160-in-patients-with-advanced-solid-tumors-100639777","NCT07623369","A First-in-Human Study of HH160 in Participants With Advanced or Metastatic Solid Tumors","An Open-Label, Multicenter, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Preliminary Antitumor Activity of HH160 Alone or in Combination With Other Antitumor Agents in Patients With Advanced or Metastatic Solid Tumors","Key Inclusion Criteria\n\n1. Adults aged 18 to 75 years with signed informed consent.\n2. Histologically or cytologically confirmed advanced solid tumors meeting phase-specific disease requirements.\n3. At least 1 measurable lesion per RECIST v1.1.\n4. Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status of 0 or 1 with life expectancy ≥ 12 weeks.\n5. Adequate organ function based on protocol-specified laboratory criteria.\n\nKey Exclusion Criteria\n\n1. Active leptomeningeal disease or uncontrolled\u002Funtreated brain metastases.\n2. History of severe hypersensitivity reactions to monoclonal antibodies, bispecific antibodies, trispecific antibodies, or study drug components.\n3. Other malignancy within 3 years prior to first dose, except specified curatively treated cancers.\n4. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage.\n5. Significant bleeding risk, severe coagulopathy, gastrointestinal hemorrhage, or recent pulmonary hemorrhage\u002Fhemoptysis.\n\nNOTE: Other eligibility criteria may apply.","75 Years",{"count":268,"type":21},299,[270],"PHASE1","This study is evaluating the safety, side effects, how the body processes HH160, and its early anticancer activity when given alone or with other cancer treatments in participants with advanced solid tumors. The study will also identify the recommended dose for future studies. The trial includes two phases and is expected to last about 4 years, with treatment and follow-up lasting approximately 6-12 months each.",[273,27,274,275,276,277,278,279,280,281,282,283],"Solid Tumor","Hepatocellular Carcinoma","Colorectal Cancer","Head and Neck Squamous Cell Carcinoma","Renal Cell Carcinoma","Endometrial Cancer","Cervical Cancer","Small-cell Lung Cancer","Triple Negative Breast Cancer","Urothelial Carcinoma","Gastroesophageal Adenocarcinoma",[285,286,27,287,274,288,275,289,290,276,277,291,278,279,280,281,292,282,283,293],"HH160","PD-1×CTLA-4×VEGF-A Antibody","NSCLC","HCC","CRC","GEA","RCC","TNBC","Ovarian Cancer",{"date":31,"type":32},{"date":296,"type":32},"2026-06-11",{"date":298,"type":21},"2028-08",{"name":300,"class":39},"Huahui Health",3,{"id":303,"slug":304,"hasResults":12,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":308,"eligibilityCriteria":309,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":310,"targetDuration":4,"studyType":22,"phases":312,"briefSummary":313,"conditions":314,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":318,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":325},"100575644","phase-1-a-phase-1-study-of-lncb74-in-advanced-solid-tumors-100575644","NCT06774963","A Phase 1 Study of LNCB74 in Advanced Solid Tumors","A Phase 1, Open-label, Dose Escalation and Dose Expansion Study for LNCB74, a B7-H4 Targeted Antibody Drug Conjugate, as Monotherapy in Participants With Advanced Solid Tumors","LNCB74-01","Inclusion Criteria:\n\n1. The participant provides written informed consent\n2. ≥ 18 years of age on day of signing informed consent.\n3. Participant with histologically or cytologically confirmed diagnosis of advanced unresectable and\u002For metastatic solid tumors\n4. A male participant must agree to use contraception and refrain from sperm donation or expecting to father a child\n5. A female participant is eligible to participate if she is not pregnant, not breastfeeding, not a woman of childbearing potential\n6. Have measurable disease per RECIST 1.1 as assessed by the local site investigator\u002Fradiology\n7. Able to provide tumor tissue sample.\n8. Willing to undergo fresh tumor biopsy at Screening and On-treatment if archival tissue not available\n9. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n10. Life expectancy greater than or equal to 12 weeks as judged by the Investigator.\n11. Have adequate organ function\n\nExclusion Criteria:\n\n1. A WOCBP who has a positive serum pregnancy test (within 72 hours) prior to treatment.\n2. Has received prior investigational agents within 4 weeks prior to treatment.\n3. Has received anti-cancer chemotherapy (Immunotherapy (non-antibody-based therapy), retinoid therapy, hormonal therapy within 2 weeks prior to treatment.\n4. Has received antibody-based anti-cancer therapy within 4 weeks prior to treatment.\n5. Has received targeted agents and small molecules within 2 weeks or 5 half-lives, whichever is longer.\n6. Has received prior platinum-based chemotherapy and progressed within 4 weeks of initiating therapy (platinum-refractory disease)\n7. Has received an ADC with MMAE payload.\n8. Has received prior radiotherapy within 2 weeks of start of study treatment for focal radiation or within 4 weeks for wide-field radiotherapy\n9. Has received G-CSF or GM-CSF within 7 days prior to start of study treatment.\n10. Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention.\n11. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug\n12. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years\n13. Has known active CNS metastases and\u002For carcinomatous meningitis\n14. Has severe hypersensitivity (≥ Grade 3), known allergy or reaction LNCB74 or any of its excipients.\n15. Has a history of (non-infectious) pneumonitis \u002F interstitial lung disease that required steroids or has current pneumonitis \u002F interstitial lung disease.\n16. Has active ≥Grade 2 sensory or motor neuropathy.\n17. Has active or chronic corneal disorders, other active ocular conditions requiring ongoing therapy or any clinically significant corneal disease.\n18. Has an active infection requiring systemic therapy.\n19. Any major surgery within 4 weeks of study drug administration.\n20. Toxicity (except for alopecia) related to prior anti-cancer therapy and\u002For surgery, unless the toxicity is either resolved, returned to baseline or Grade 1, or deemed irreversible.\n21. Prior organ or tissue allograft.\n22. Uncontrolled or significant cardiovascular disease\n23. Participants with serious or uncontrolled medical disorders.\n24. Participants who are on total parenteral nutrition (TPN)\n25. Participants with history of bowel obstruction within one month of screening\n26. Participants with history of significant ascites requiring paracentesis within 2 weeks of screening\n27. Has a known history of human immunodeficiency virus (HIV) infection with an acquired immune deficiency syndrome (AIDS)-defining opportunistic infection within the last year, or a current CD4 count \\\u003C350 cells\u002Fµl\n28. Has known active Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection\n29. Has a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study\n30. Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study",{"count":311,"type":21},145,[270],"This is an open-label, phase 1, dose escalation and dose expansion study to determine safety and tolerability, and to determine the maximum tolerated dose and \u002F or recommended phase 2 dose of LNCB74 in participants with advanced solid tumors.",[293,315,278,316,196,317],"Breast Cancer","Biliary Tract Cancer","Advanced or Metastatic Solid Tumors",{"date":31,"type":32},{"date":320,"type":32},"2025-01-07",{"date":322,"type":21},"2026-12",{"name":324,"class":39},"NextCure, Inc.",14,{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":4,"eligibilityCriteria":332,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":333,"targetDuration":4,"studyType":22,"phases":335,"briefSummary":336,"conditions":337,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":338,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":344},"100548526","phase-3-pembrolizumab-with-or-without-maintenance-sacituzumab-tirumotecan-sac-tmt-mk-2870-in-metastatic-squamous-non-small-cell-lung-cancer-nsclc-mk-2870-023-100548526","NCT06422143","Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023]","Phase 3 Study of Pembrolizumab in Combination With Carboplatin\u002FTaxane (Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab With or Without Maintenance MK-2870 in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (NSCLC) \\[Stage IV: M1a, M1b, M1c, American Joint Committee on Cancer Staging Manual, version 8\\]\n* Measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 as assessed by the local site investigator\u002Fradiology\n* Has life expectancy ≥3 months\n* Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1 assessed within 7 days prior to allocation\n* Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)\n* Participants who are hepatitis B surface antigen (HBsAg)-positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before allocation\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n* Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to Grade ≤1 or baseline (participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible)\n* Has adequate organ function\n* For Maintenance only (prior to randomization): is without disease progression of their NSCLC, as determined by BICR using RECIST 1.1 after completion of study-specified Induction with an evaluable scan at Week 12 or most recent scan before randomization\n* For Maintenance only (prior to randomization): has ECOG PS of 0 or 1 as assessed at the Prerandomization Visit\n* For Maintenance only (prior to randomization): all AEs (with the exception of alopecia, Grade ≤2 fatigue, Grade ≤2 peripheral neuropathy, and Grade ≤2 endocrine-related AEs requiring treatment or hormone replacement) have recovered\n* For Maintenance only (prior to randomization): has not experienced a pneumonitis\u002Finterstitial lung disease (ILD) event during the study-specified induction\n\nExclusion Criteria:\n\n* Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements\n* History of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or severe corneal disease that prevents\u002Fdelays corneal healing\n* Active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to \\>480 ms, and other serious cardiovascular and cerebrovascular diseases within 6 months before study intervention\n* HIV-infected participants who have been newly diagnosed or with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC. Note: Prior treatment with chemotherapy and\u002For radiation as a part of neoadjuvant or adjuvant therapy or chemoradiation therapy for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC\n* Received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti programmed cell death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T lymphocyte-associated protein 4, OX-40, CD137). Note: Prior treatment with an anti-PD-1 or anti-PD-L1 agent for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC\n* Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-targeted antidrug conjugate (ADC)\n* Received radiation therapy to the lung that is \\>30 Gray within 6 months of start of study intervention\n* Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention\n* Participants who have not adequately recovered from major surgery or have ongoing surgical complications\n* Received prior treatment with a topoisomerase I inhibitor-containing ADC\n* Is currently receiving a strong inducer\u002Finhibitor of CYP3A4 that cannot be discontinued for the duration of the study (the required washout period before starting sac-TMT is 2 weeks)\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n* Has known central nervous system (CNS) metastases\u002Fcarcinomatous meningitis\n* Severe hypersensitivity (≥Grade 3) to study intervention and\u002For any of its excipients or to another biologic therapy\n* Active autoimmune disease that has required systemic treatment in the past 2 years (replacement therapy \\[eg, thyroxine, insulin, or physiologic corticosteroid\\] is allowed)\n* Has a history of (noninfectious)pneumonitis\u002FILD that required steroids, has current pneumonitis\u002FILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening\n* Active infection requiring systemic therapy\n* History of allogeneic tissue\u002Fsolid organ transplant",{"count":334,"type":21},851,[24],"This is a phase 3 study of pembrolizumab in combination with carboplatin\u002Ftaxane (paclitaxel or nab-paclitaxel) followed by pembrolizumab with or without maintenance sacituzumab tirumotecan (sac-TMT; MK-2870) in first-line treatment of metastatic squamous non-small cell lung cancer. It is hypothesized that pembrolizumab with maintenance sacituzumab tirumotecan is superior to pembrolizumab without sacituzumab tirumotecan maintenance with respect to overall survival (OS).",[27,287],{"date":29,"type":32},{"date":340,"type":32},"2024-06-10",{"date":342,"type":21},"2031-08-15",{"name":38,"class":39},215,{"id":346,"slug":347,"hasResults":12,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":351,"eligibilityCriteria":352,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":353,"targetDuration":4,"studyType":355,"phases":4,"briefSummary":356,"conditions":357,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":358,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":364},"100521319","osireal---osimertinib-rwe-on-egfrm-nsclc-in-spain-100521319","NCT06068049","OSIREAL - Osimertinib RWE on EGFRm NSCLC in Spain","An Ambispective, Non-interventional, Multiple Cohort Study to Assess the Management of Osimertinib Treatment in Patients With EGFRm Non-small Cell Lung Cancer Under Real-world Conditions in Spain","OSIREAL","Inclusion Criteria:\n\n* Female or male patients, treated with osimertinib\n* Age ≥ 18 years at starts of osimertinib treatment (i.e., index date).\n* Patients histologically diagnosed with EGFRm NSCLC (before index date):\n\n  * Patients with first-line treatment with EGFRm locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy (Cohort 1).\n  * Patients with stage IB-IIIA whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, after complete tumor resection (Cohort 2).\n  * Patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, that received osimertinib in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment (Cohort 3).\n  * Patients with locally advanced, unresectable NSCLC treated with osimertinib, whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy (cohort 4).\n* Provision of informed consent (for alive patients). Deceased patients who met the selection criteria when they started treatment with osimertinib could also be included in the study.\n\nExclusion Criteria:\n\n* Osimertinib treatment administration in a clinical trial setting.",{"count":354,"type":21},500,"OBSERVATIONAL","Lung cancer (LC) is the tumor responsible for the highest mortality worldwide. Lung adenocarcinoma is the major subtype of lung cancer and represents the deadliest human cancer, affecting current-, ex-, and even non-smokers.\n\nOsimertinib is indicated as monotherapy for the first-line (1L) treatment of adult patients with locally advanced or metastatic NSCLC with activating mutations in the EGFR, for the treatment of adult patients with EGFR T790M mutation-positive locally advanced or metastatic NSCLC, for the adjuvant treatment of adult patients with NSCLC stages IB-IIIA after complete resection of the tumor that has activating mutations of the EGFR, for the treatment of adult patients with locally advanced, unresectable NSCLC whose tumours have EGFR exon 19 deletions or exon 21 substitution mutation and whose disease has not progressed during or following platinum-based chemoradiation therapy, and in combination with pemetrexed and platinum-based chemotherapy for the 1L treatment of adult patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 substitution mutations.\n\nThe FLAURA trial showed that treatment with osimertinib significantly prolongs PFS and improves overall survival (OS) compared to standard EGFR tyrosine kinase inhibitors.\n\nThe results of the ADAURA study showed a reduction in the risk of recurrence or death by 83% in stages II to IIIA, and in 80% in stages IB-IIIA. Additionally, osimertinib demonstrated a highly statistically significant improvement in DFS and HRQoL was maintained.\n\nThe FLAURA2 trial showed that 1L treatment with osimertinib-chemotherapy led to significantly longer progression-free survival than osimertinib monotherapy among patients with EGFR mutated (EGFRm) advanced NSCLC.\n\nThe LAURA trial showed that treatment with osimertinib after chemoradiotherapy resulted in significantly longer PFS than placebo among patients with unresectable stage III EGFRm NSCLC.\n\nTo date, there are no real-world data on osimertinib either in 1L treatment in locally advanced or metastatic EGFRm NSCLC nor as adjuvant treatment, in early stages of cancer, regarding effectiveness, adherence, treatment exposure and quality of life (QoL), among others, and in particular for the use of osimertinib in subpopulations less represented in pivotal trials such as elderly or patients with uncommon EGFR mutations. Furthermore, the duration of treatment in real life in Spain is also a gap, as it appears to be longer than in clinical trials, which means that there are patients who are treated beyond progression.\n\nTherefore, this observational ambispective study based on real-world data aims to provide data on osimertinib use as adjuvant treatment in adult patients diagnosed with stages IB-IIIA EGFRm NSCLC, in 1L treatment in patients with locally advanced or metastatic EGFRm NSCLC, as consolidation treatment in patients with locally advanced, unresectable NSCLC whose tumours have EGFR exon 19 deletions or exon 21 substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy, and in combination with pemetrexed and platinum-based chemotherapy in patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution. Specifically, the study will focus on patient characteristics, adherence, treatment exposure, administration, survival, quality of life, effectiveness and safety providing insights into osimertinib use in daily practice for patients with EGFRm NSCLC, where there are current evidence gaps.",[27],{"date":29,"type":32},{"date":360,"type":32},"2023-07-28",{"date":362,"type":21},"2029-06-15",{"name":179,"class":39},26,{"id":366,"slug":367,"hasResults":12,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":4,"eligibilityCriteria":371,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":372,"targetDuration":4,"studyType":22,"phases":373,"briefSummary":374,"conditions":375,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":376,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":380,"locationsCount":237},"100434190","phase-2-bruog-397-neo-rad-low-neoadjuvant-low-dose-stereotactic-body-radiotherapy-ipilimumab-and-nivolumab-100434190","NCT04933903","BrUOG 397: NEO Rad (LOW): Neoadjuvant Low Dose Stereotactic Body Radiotherapy, Ipilimumab and Nivolumab","BrUOG 397: NEO Rad (LOW): Neoadjuvant Low Dose Stereotactic Body Radiotherapy, Ipilimumab and Nivolumab for Patients With Resectable Stage IB - III Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Pathologically confirmed NSCLC\n2. Age \\> 18\n3. ECOG Performance Status 0-1.\n4. Pulmonary function capacity capable of tolerating the proposed lung resection. FEV1 at least 2 L. If less than 2 L, the predicted postoperative forced expiratory volume in 1 second (FEV1) must be \\> 0.8 L or be \\> 35% of the predicted value. Postoperative predicted DLCO ≥ 35% is required.\n5. Resectable stage IB-IIIB (T2-3N0, T1-T3N1-2) NSCLC (per the 8th Edition American Joint Committee on Cancer (AJCC) classification) who are candidates for surgery with intent of R0 resection. Invasive T3 disease (eg, phrenic nerve, pericardium, chest wall other than Pancoast superior sulcus) may be included if the surgeon and study team deem it to be resectable.\n6. N2 nodes must be discrete (ie, not invading surrounding structures). If patients have N2 disease, as suspected by CT or PET, histologic proof of N2 status is recommended.\n7. Patients must be evaluated by a Thoracic Surgeon prior to registration. Operability is defined as having adequate pulmonary, cardiac, renal, nutritional, musculoskeletal, neurologic, and cognitive capacity to undergo major pulmonary resection with acceptable morbidity and mortality. Absence of major associated comorbidities that increase the surgery risk to an unacceptable level.\n8. No prior history of thoracic radiation.\n9. Adequate Organ and marrow function as defined below\n\n   * leukocytes ≥2,000\u002FmcL,\n   * absolute neutrophil count ≥1,000\u002FmcL,\n   * platelets ≥100,000\u002FmcL,\n   * Hemoglobin \\>8.0 g\u002FdL\n   * Total bilirubin within normal institutional limits\n   * AST(SGOT)\u002FALT(SGPT) ≤2.5 × institutional upper limit of normal\n   * creatinine within normal institutional limits OR creatinine clearance ≥50 mL\u002Fmin\u002F1.73 m2 for participants with creatinine levels above institutional normal.\n10. Patients are capable of giving informed consent and\u002For have an acceptable surrogate capable of giving consent on the subject's behalf.\n11. Nonpregnant and non-nursing. The effect of ipilimumab and nivolumab on the fetus is unknown.\n12. Women of childbearing potential (WOCBP) must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 5 months after the last dose of study medication. Patients of childbearing potential are those who have not been surgically sterilized or have not been free of menses \\>1 year.\n13. Evidence of postmenopausal status or negative urinary or serum pregnancy test for female premenopausal patients. Women will be considered postmenopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n14. Women \\\u003C50 years of age would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the postmenopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).\n15. Women ≥50 years of age would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \\>1 year ago, had chemotherapy-induced menopause with last menses \\>1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).\n16. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n17. Male patients must agree to use an adequate method of contraception starting with the first dose of study therapy through 7 months after the last dose of study therapy.\n\nExclusion Criteria:\n\n1. Pathologically confirmed NSCLC \\*\n2. Age \\> 18 \\*\n3. ECOG Performance Status 0-1.\n4. Pulmonary function capacity capable of tolerating the proposed lung resection. FEV1 at least 2 L. If less than 2 L, the predicted postoperative forced expiratory volume in 1 second (FEV1) must be \\> 0.8 L or be \\> 35% of the predicted value. Postoperative predicted DLCO ≥ 35% is required.\n5. Resectable stage IB-IIIB (T2-3N0, T1-T3N1-2) NSCLC (per the 8th Edition American Joint Committee on Cancer (AJCC) classification) who are candidates for surgery with intent of R0 resection. Invasive T3 disease (eg, phrenic nerve, pericardium, chest wall other than Pancoast superior sulcus) may be included if the surgeon and study team deem it to be resectable.\n6. N2 nodes must be discrete (ie, not invading surrounding structures). If patients have N2 disease, as suspected by CT or PET, histologic proof of N2 status is recommended.\n7. Patients must be evaluated by a Thoracic Surgeon prior to registration. Operability is defined as having adequate pulmonary, cardiac, renal, nutritional, musculoskeletal, neurologic, and cognitive capacity to undergo major pulmonary resection with acceptable morbidity and mortality. Absence of major associated comorbidities that increase the surgery risk to an unacceptable level. \\*\n8. No prior history of thoracic radiation.\n9. Adequate Organ and marrow function as defined below\n\n   * leukocytes ≥2,000\u002FmcL,\n   * absolute neutrophil count ≥1,000\u002FmcL,\n   * platelets ≥100,000\u002FmcL,\n   * Hemoglobin \\>8.0 g\u002FdL\n   * Total bilirubin within normal institutional limits\n   * AST(SGOT)\u002FALT(SGPT) ≤2.5 × institutional upper limit of normal\n   * creatinine within normal institutional limits OR creatinine clearance ≥50 mL\u002Fmin\u002F1.73 m2 for participants with creatinine levels above institutional normal.\n10. Patients are capable of giving informed consent and\u002For have an acceptable surrogate capable of giving consent on the subject's behalf.\n11. Nonpregnant and non-nursing. The effect of ipilimumab and nivolumab on the fetus is unknown.\n12. Women of childbearing potential (WOCBP) must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 5 months after the last dose of study medication. Patients of childbearing potential are those who have not been surgically sterilized or have not been free of menses \\>1 year.\n13. Evidence of postmenopausal status or negative urinary or serum pregnancy test for female premenopausal patients. Women will be considered postmenopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n14. Women \\\u003C50 years of age would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the postmenopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).\n15. Women ≥50 years of age would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \\>1 year ago, had chemotherapy-induced menopause with last menses \\>1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).\n16. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n17. Male patients must agree to use an adequate method of contraception starting with the first dose of study therapy through 7 months after the last dose of study therapy.",{"count":7,"type":21},[157],"This single-arm phase 2 study will enroll patients with resectable and operable stage IB - III non-small cell lung cancer and treat them with pre-operative ipilimumab + nivolumab plus low-dose stereotactic body radiation therapy (SBRT) delivered concurrently. Only patients who proceed to surgery will be evaluable for the primary endpoint. The primary efficacy outcome measurement will be pathologic response (including Major Pathologic Response (MPR), and Complete Pathologic Response (CPR)). Secondary outcome measures include safety, and exploratory biomarkers of immune response in pre- and post-operative blood and tissue. A two-stage design will stop the study if fewer than 3 of the first 9 evaluable patients do not achieve MPR. An early stopping rule for safety will stop the study if more than 12 patients are enrolled to find the first 9 evaluable patients.",[113],{"date":29,"type":32},{"date":378,"type":32},"2021-10-05",{"date":322,"type":21},{"name":381,"class":210},"Brown University",{"id":383,"slug":384,"hasResults":12,"nctId":385,"briefTitle":386,"officialTitle":386,"acronym":4,"eligibilityCriteria":387,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":388,"enrollmentInfo":389,"targetDuration":4,"studyType":22,"phases":391,"briefSummary":392,"conditions":393,"keywords":4,"overallStatus":201,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":237},"100652142","phase-2-concurrent-immunotherapy-and-systemic-therapy-with-stereotactic-body-radiation-therapy-sbrt-for-stage-iv-cancers-coinsss-iv-100652142","NCT07770100","Concurrent Immunotherapy and Systemic Therapy With Stereotactic Body Radiation Therapy (SBRT) for Stage IV Cancers (COINSSS IV)","Inclusion Criteria:\n\n* Histologically proven advanced or stage IV head \\& neck, non-small cell lung cancer, cervical, esophageal, gastric, and gastroesophageal cancer at least 6 metastases that are eligible for SBRT comprising: lung, liver, adrenal glands, bone, and lymph node sites with at least 1 other lesion meeting RECIST criteria of which this additional lesion not be treated with SBRT (biopsies performed for diagnosis are standard of care).\n* At least 6 metastases eligible for SBRT comprising: lung, liver, adrenal glands, bone, and lymph node sites\n* The 1 irradiated lesion must have a max point dose of 5Gy or less.\n* Eligible for Immunotherapy for an FDA-approved indication as defined in section 6.1. NOTE: No limit is placed on prior systemic treatment unless it affects the eligibility for administration of immune checkpoint inhibitor therapy.\n* If prior treatment with chemotherapy or radiotherapy or surgery has occurred: Prior chemotherapy or radiation must have concluded \\> 21 days prior to the start of study treatment. Exception: study treatment can start within 2-3 days following GKS \\[gamma knife surgery\\] or whole brain radiation therapy \\[ WBRT\\], as long as patient is not experiencing ongoing\u002Fresidual AE's related to GKS or WBRT at discretion of treating physician.\n* First Line immunotherapy-based treatments only. The patient may have received prior cycles of immunotherapy, but has to be on the first line of immunotherapy-based treatments.\n* If non-small cell lung cancer patient with pembrolizumab, PD-L1 testing CPS score \\> or = to 50% will have to be shown\n* If cervical cancer patient on secondary line therapy with pembrolizumab, CPS score of \\> or = to 1 will have to be done. Please note, second line therapy with pembrolizumab is only allowed if the patient's first line of therapy did NOT include immunotherapy.\n* If non-small cell lung cancer on first line ipilimumab in combination with nivolumab, PD-L1 of 1% and negative epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.\n* If pembrolizumab is given for a gastric cancer, a PD-L1 expression (CPS =1) will need to be shown\n* If pembrolizumab is given as a single agent treatment after progression of one prior systemic therapy agent for esophageal or gastroesophageal squamous cell carcinoma histology, a PD-L1 (CPS=1) expression will have to be shown.\n* ECOG Performance Status 0 - 1 (see Appendix A).\n* Life expectancy \\> or equal to 6 months.\n* Adequate organ and bone marrow function prior to study treatment as defined by: Thresholds for lab values prior to initiation of study treatment.\n* ANC \\> or equal to 1,000\u002Fmm3\n* Platelets \\> or equal to 100,000\u002Fmm3\n* Total bilirubin \\\u003C or equal to or equal to 1.5 x ULN\n* AST and ALT - With hepatic metastasis, \\\u003C or equal to or equal to 5 x ULN. If no hepatic metastasis, \\\u003C or equal to 2.5 times x ULN\n* Creatinine Or Creatinine Clearance \\\u003C or equal to 1.5 x ULNand\u002For CrCl \\> or equal to 30ml\u002Fmin (per 24-hour urine collection) or calculated according to the Cockcroft-Gault formula (Appendix B)\n* No previous or concurrent malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for the past 3 years.\n* Non-pregnant and non-nursing women -Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment.\n* Women of childbearing potential and men must agree to use adequate contraception methods prescribed their the patients primary care physician, urologist, or obstetrician\u002Fgynecologist prior to study entry and for the duration of study participation.\n* Subjects should use adequate birth control for at least 3 months after the last administration of immune checkpoint inhibitors.\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Presence of \\\u003C or equal to 5 sites amenable to SBRT\n* Ineligible for immune checkpoint inhibitors based on package insert of the chosen immune checkpoint inhibitor\n* No more than 7 metastatic sites to an organ, defined as liver, left lung, right lung, single anatomically bone site (e.g. femur, humerus, single vertebral body).\n\nNOTE: Multiple different vertebral bodies are allowed.\n\n* Peritoneal involvement, at the discretion of the study PI. NOTE: Peritoneal metastasis does not exclude GI nor cervical cancer, except in cases where there is a separate focus of spread to the peritoneum.\n* Presence of liver cirrhosis of any grade prohibits SBRT to the liver. NOTE: Pt can enroll to trial if receiving SBRT to other non-liver metastatic sites.\n* A plan that cannot meet organ at risk tolerance (as defined in section 6.7.2.1) Auto-immune diagnosis Medications prohibited while receiving concurrent SBRT: gemcitabine, Adriamycin, VEGF or BRAF inhibitors.\n\nNOTE: However, if the patient is on the prohibited agent(s), the patient is still eligible for the trial so long as the prohibited agent can safely be held for at least 1 month before starting SBRT, during SBRT, and 1 month after completion of SBRT.\n\n-Major surgical procedure (including craniotomy and open brain biopsy) or significant traumatic injury (injury requiring immediate surgical intervention or involving loss of consciousness) within 14 days prior to registration or those patients who receive a nonCNS minor surgical procedures (e.g. core biopsy or fine needle aspiration) within 3 days prior to registration.\n\nNOTE: There is no waiting period for central line placement. There is a 7-day window for recovery prior to registration for patients who underwent stereotactic biopsy of the brain.\n\n* Active clinically serious infection \\> CTCAE Grade 2.\n* Serious non-healing wound, ulcer or bone fracture.\n* Uncontrolled inter-current illness. This includes, but is not limited to: ongoing or active infection; symptomatic congestive heart failure (NYHA class III or IV); unstable angina pectoris or new onset angina that began within the last 3 months; cardiac ventricular arrhythmias requiring anti-arrhythmic therapy; thrombotic\u002F embolic events such as cerebrovascular accident, including transient ischemic attacks within the past 6 months;\n* Uncontrolled hypertension defined as systolic blood pressure \\>150 mmHg or diastolic pressure \\> 90 mmHg, despite optimal medical management; Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C; Known Grade 3 or 4 neurotoxicity.\n* Receipt of live attenuated vaccine within 30 days prior to the first dose of ICI.\n\nNote: Patients, if randomized, should not receive live vaccine while receiving ICI and up to 30 days after the last dose of ICI.\n\n-Inclusion of Women and Minorities - Consistent with NIH policy, both men and women of all races and ethnic groups are eligible for this trial.","99 Years",{"count":390,"type":21},35,[157],"This is a Phase II clinical study for people with stage IV cancer. The study will evaluate the use of stereotactic body radiation therapy (SBRT), a type of focused radiation treatment, together with immunotherapy-based treatment. SRBT will be used to treat multiple areas of cancer that have spread to other parts of the body. The study will evaluate whether this treatment approach can be safely given while patients continue their planned cancer treatment and may help control their cancer.",[394,196,279,395,396],"Head and Neck Cancer","Esophageal Cancer","Gastric Cancer (GC)","2026-08-18",{"date":29,"type":32},{"date":400,"type":21},"2026-10-01",{"date":402,"type":21},"2040-02-28",{"name":404,"class":210},"Mark Bernard",{"id":406,"slug":407,"hasResults":12,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":4,"eligibilityCriteria":411,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":266,"enrollmentInfo":412,"targetDuration":4,"studyType":22,"phases":414,"briefSummary":415,"conditions":416,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":417,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":237},"100618261","phase-2-phase-ii-study-of-sacituzumab-tirumotecan-in-combination-with-osimertinib-or-sacituzumab-tirumotecan-for-neoadjuvant-treatment-in-patients-with-resectable-epidermal-growth-factor-receptor-egfr-mutated-non-small-cell-lung-cancer-100618261","NCT07329322","Phase II Study of Sacituzumab Tirumotecan in Combination With Osimertinib for Neoadjuvant Treatment in Patients With Resectable Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer","A Multicenter, Phase II Clinical Study to Evaluate the Safety and Efficacy of Sacituzumab Tirumotecan in Combination With Osimertinib for Neoadjuvant Treatment in Patients With Resectable Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Male or female, ≥ 18 and ≤ 75 years at the time of signing the informed consent form (ICF).\n2. Histologically or cytologically confirmed NSCLC.\n3. No prior systemic anti-tumor therapy.\n4. No prior local therapy for NSCLC.\n5. Confirmed by tumor histology, or cytology to have EGFR sensitizing mutations.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization.\n7. At least one target lesion as assessed by the investigator according to RECIST v1.1.\n8. Life expectancy ≥ 24 weeks.\n9. Adequate organ and bone marrow function.\n10. For female participants of childbearing potential and male participants with partners of childbearing potential, they must agree to use effective medical contraception from the start of signing the ICF until 6 months after the last dose.\n11. Participants must voluntarily join this study, sign the ICF, and be able to comply with the protocol-specified visits and related procedures.\n\nExclusion Criteria:\n\n1. Tumor histology or cytology confirming combined small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma or squamous cell carcinoma components of more than 10%.\n2. Participants with other malignant tumors within 3 years prior to randomization.\n3. Resting electrocardiogram (ECG) showing clinically significant abnormal results.\n4. Presence of any of the following cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.\n5. Uncontrolled systemic diseases in the investigator's judgment.\n6. History of interstitial lung disease (ILD), drug-induced ILD, or non-infectious pneumonitis, have current ILD or non-infectious pneumonitis.\n7. Clinically severe lung damage due to complications of lung disorder.\n8. Participants who have received systemic corticosteroids therapy with \\> 10 mg\u002Fday of prednisone or other immunosuppressive drugs within 2 weeks before randomization.\n9. Known active pulmonary tuberculosis.\n10. Known history of allogeneic organ transplant and allogeneic hematopoietic stem cell transplant.\n11. Active hepatitis B.\n12. Positive for human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.\n13. Known hypersensitivity to osimertinib, sacituzumab tirumotecan, or any of their components (including but not limited to polysorbate-20); known history of severe hypersensitivity to other biologics.\n14. Have received a live vaccine within 30 days prior to randomization, or plan to receive a live vaccine during the study.\n15. Pregnant or lactating women.\n16. Any condition that, in the investigator's opinion, would interfere with the evaluation of the study drug, participant safety, or interpretation of study results, or any other condition that the investigator considers unsuitable for participation in this study.",{"count":413,"type":21},30,[157],"The aim of the study to evaluate the safety and efficacy of Sacituzumab Tirumotecan in combination with osimertinib for neoadjuvant treatment in patients with resectable Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer.",[196],{"date":29,"type":32},{"date":419,"type":32},"2026-03-30",{"date":421,"type":21},"2032-10-31",{"name":423,"class":39},"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.",{"id":425,"slug":426,"hasResults":12,"nctId":427,"briefTitle":428,"officialTitle":428,"acronym":4,"eligibilityCriteria":429,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":430,"targetDuration":4,"studyType":22,"phases":432,"briefSummary":433,"conditions":434,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":436,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":237},"100603200","phase-2-a-phase-2-platform-study-of-immunomodulatory-compounds-in-ici-refractory-non-small-cell-lung-cancer-100603200","NCT07133425","A Phase 2 Platform Study of Immunomodulatory Compounds in ICI-refractory Non-small Cell Lung Cancer","Eligibility Criteria\n\n1. Ability to understand and willingness to sign informed consent form (ICF) prior to initiation of the study and any study procedures.\n2. Age ≥18 years. Because no dosing or adverse event data are currently available on the use of SAR445877 in participants \\\u003C18 years of age, children are excluded from this study.\n3. Participants with histologically documented locally advanced or metastatic NSCLC who have had disease progression after treatment with all available therapies for metastatic disease that are known to confer clinical benefit, or are intolerant to treatment, or refuse standard treatment:\n4. Prior immune checkpoint inhibitor (anti-PD-(L)1) exposure. Participants need to have received at least 6 weeks of exposure to anti-PD-(L)1 and developed disease progression. Treatment with neoadjuvant or adjuvant ICI is acceptable if participant developed progression within one year of start of ICI therapy.\n5. One lesion suitable for repeat biopsy without significant risk to the participant.\n6. Measurable disease per RECIST v1.1.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 .\n8. Adequate organ and marrow function as defined below, obtained before study treatment initiation:\n\n   1. Hemoglobin \\>9.0 g\u002FdL\n   2. Absolute neutrophil count ≥1000\u002FmcL\n   3. Platelets ≥75,000\u002FmcL\n   4. Total bilirubin ≤1.5 institutional upper limit of normal (ULN). Documented Gilbert syndrome is allowed if total bilirubin is ≤3 × ULN.\n   5. AST\u002FALT ≤2.5 × institutional ULN. Transaminases up to 5 × ULN in the presence of liver metastases.\n   6. Measured or calculated creatinine clearance (CrCl; glomerular filtration rate can also be used in place of creatinine or CrCl) ≥30 mL\u002Fmin (CrCl should be calculated per institutional standard).\n   7. For participants not receiving therapeutic anticoagulation: international normalized ratio or activated partial thromboplastin time ≤1.5 × ULN. For participants receiving therapeutic anticoagulation: stable anticoagulant regimen.\n9. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test result at screening.\n10. WOCBP must agree to use highly effective contraception for the duration of study participation and for 60 days after completion of study treatment. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a post-menopausal state (≥12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and\u002For uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this study must also agree to use adequate contraception for the duration of study participation and for 60 days after completion of study treatment. In addition, male participants must be willing to refrain from sperm donation during this time.\n11. Willing to undergo mandatory biopsies and blood collections as required by the study.\n12. Participants with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression and participant is clinically stable without requirement of steroid treatment for ≥ 7 days prior to the first dose of study treatment.\n13. Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n\nExclusion Criteria\n\n1. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drugs.\n2. Participants who are pregnant or breastfeeding.\n3. Participants with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n4. Participants with a condition requiring systemic treatment with either corticosteroid (\\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of study treatment initiation. Inhaled or topical steroids, and adrenal replacement steroid doses, are permitted in the absence of active autoimmune disease.\n5. History of interstitial lung disease (ILD) or checkpoint inhibitor-induced pneumonitis.\n6. Known history of positive test for human immunodeficiency virus or known acquired immunodeficiency syndrome.\n7. Acute or chronic hepatitis B virus or hepatitis C virus infection. Prior viral exposure with cleared or fully treated infection based on negative HCV viral load is permitted.\n8. Previous solid organ or allogeneic hematopoietic stem cell transplant.\n9. Active infection requiring IV antibiotics or other uncontrolled intercurrent illness requiring hospitalization.\n10. Significant cardiovascular\u002Fcerebrovascular disease, including stroke, myocardial infarction, or prolonged QTc (\\> 480msec) within 3 months. Participants on beta blockers must be able to stop beta blockers for duration of their time on study treatment period when applicable.\n11. Participants who have not recovered from AEs due to prior anticancer therapy (i.e., have residual toxicities \\> Grade 1) with the exception of alopecia, hearing loss, grade 2 neuropathy or endocrinopathy managed with hormone replacement therapy.\n12. Participants who have previously been treated with PD-1, PD-L1, or CTLA-4 inhibitors and required permanent discontinuation or systemic immunosuppression (e.g. immune inhibitory monoclonal antibodies) due to irAEs.\n13. Participants who are receiving any other investigational agents.\n14. Treatment with a live, attenuated vaccine within 4 weeks prior to study treatment initiation, or anticipation of need for such a vaccine during the course of the study or within 5 months after the last dose of study treatment. Non-live COVID vaccines will be allowed on study, but it is recommended to avoid their use during the first treatment cycle (from 3 days prior to Cycle 1 Day 1 through Cycle 2 Day 3).\n15. Participants must have adequate washout from prior therapy at the time of study treatment initiation: 4 weeks from major surgery; 4 weeks from antibody-based therapy; 3 weeks from prior PD-(L)1 inhibitor exposure; 2 weeks or 5 half-lives (whichever is shorter) from any targeted therapy or small molecule therapy; 3 weeks or 5 half-lives (whichever is shorter) from chemotherapy or 6 weeks in the case of certain therapies (e.g., extensive radiotherapy, mitomycin C, and nitrosoureas); and 2 weeks from radiation therapy. Palliative radiotherapy is permitted for a preexisting lesion, provided it does not interfere with the assessment of tumor target lesions (e.g., the lesion to be irradiated must not be a site of measurable disease).\n16. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, ductal carcinoma in situ, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer.\n17. Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study.\n18. Inability to comply with the study and follow-up procedures.",{"count":431,"type":21},29,[157],"To learn if SAR445877 can help to control locally advanced or metastatic NSCLC in patients who have previously received ICI therapy.",[196,435],"ICI-refractory",{"date":29,"type":32},{"date":438,"type":32},"2025-11-06",{"date":440,"type":21},"2030-02-01",{"name":442,"class":210},"M.D. Anderson Cancer Center",{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":4,"eligibilityCriteria":449,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":450,"targetDuration":4,"studyType":22,"phases":452,"briefSummary":447,"conditions":453,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":459,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":464,"locationsCount":465},"100601788","phase-1-a-study-to-investigate-safety-of-azd6750-in-adult-participants-with-select-advanced-or-metastatic-solid-tumors-100601788","NCT07115043","A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors","A Phase I\u002FII Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6750, a CD8 Guided IL-2 Agent Alone and in Combination With Other Anti-cancer Agents in Participants With Select Advanced or Metastatic Solid Tumors","Inclusion criteria:\n\n* Participant ≥ 18 year\n* ECOG PS of 0 to 1\n* Provision of 'archival' tumor specimen\n* At least one measurable lesion according to RECIST v1.1,\n* Minimum life expectancy of 12 weeks\n* Adequate and stable cardiac function\n* Adequate bone marrow, liver and kidney function\n* Body weight ≥ 35 kg\n* Capable of giving signed informed consent\n\nModule 1 specific inclusion criteria:\n\n• Participants with locally advanced or metastatic select solid tumors (MM, Squamous cell carcinoma of skin, MCC, NSCLC, Head and neck squamous cell carcinoma, Gastric cancer\u002Fgastroesophaegeal junction cancer, RCC, HGSOC, Triple negative breast cancer) who have received adequate SoC\n\nModule 2 specific inclusion criteria:\n\n* Participants with Stage IV NSCLC Dose Escalation\u002FBackfills\n\n  1. Have received at least one prior regimen in metastatic setting (2L+ NSCLC). Participants with actionable tumor alterations should have received targeted therapy if locally available OR\n  2. Have not received systemic therapy (1L NSCLC) and have PD-L1 expression ≥ 1%.\n\n     Dose Expansion\n\n  \u003C!-- -->\n\n  1. Have not received systemic therapy (1L NSCLC) and have PD-L1 expression ≥ 1%.\n\n     Exclusion criteria:\n* Any evidence of:\n\nSevere or uncontrolled systemic diseases including respiratory, cardiac or tumor-related conditions\n\n* History or planned organ or allogeneic stem cell transplantation.\n* Active or prior documented autoimmune or inflammatory disorders, within the past 3 years\n* Any prior toxicities that led to permanent discontinuation of prior immunotherapy\n* Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anti-cancer therapy\n* Brain metastases unless treated, asymptomatic, stable, and not requiring continuous corticosteroids\n* Acute untreated or symptomatic malignant spinal cord compression, or a history of leptomeningeal carcinomatosis.\n* Active uncontrolled or chronic infection of hepatitis B, hepatitis C\n* Prior history of Grade ≥ 3 non-infectious pneumonitis.\n* Participant requires chronic immunosuppressive therapy (including steroids \\> 10 mg prednisone\u002Fday or equivalent).\n* Receipt of live attenuated vaccine within 30 days.\n\nModule 2 specific exclusion criteria:\n\n* Previous treatment with anti-TIGIT therapy\n* 1L NSCLC participants with genetic alteration such as EGFR that has a targeted therapy in 1L as per local SoC",{"count":451,"type":21},120,[270,157],[454,27,455,277,456,281,276,457,458],"Melanoma","Squamous Cell Carcinoma (Skin)","Merkel Cell Carcinoma","Gastric Cancer\u002FGastroesophageal Junction Cancer","High Grade Serous Ovarian Carcinoma",{"date":202,"type":32},{"date":461,"type":32},"2025-07-29",{"date":463,"type":21},"2029-10-02",{"name":179,"class":39},13,{"id":467,"slug":468,"hasResults":12,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":472,"eligibilityCriteria":473,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":474,"targetDuration":4,"studyType":22,"phases":475,"briefSummary":476,"conditions":477,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":478,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":485},"100575071","phase-3-clinical-study-of-ivonescimab-for-first-line-treatment-of-metastatic-nsclc-patients-with-high-pd-l1-100575071","NCT06767514","Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients With High PD-L1","A Randomized, Double-blinded, Multiregional Phase 3 Study of Ivonescimab Versus Pembrolizumab for the First-line Treatment of Metastatic Non-small Cell Lung Cancer in Patients Whose Tumors Demonstrate High PD-L1 Expression","HARMONi-7","Inclusion Criteria:\n\n* Age ≥ 18 years old at the time of enrollment\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1\n* Expected life expectancy ≥ 3 months\n* Metastatic (Stage IV) NSCLC\n* Histologically or cytologically confirmed squamous or non-squamous NSCLC\n* Tumor demonstrates high PD-L1 expression ( TPS\\>50%) based on a 22C3 immunohistochemistry ( IHC) clinical assay approved \u002F cleared by local health authorities.\n* At least one measurable noncerebral lesion according to RECIST 1.1\n* No prior systemic treatment for metastatic NSCLC.\n\nExclusion Criteria:\n\n* Histologic or cytopathologic evidence of the presence of small cell lung carcinoma for which first-line approved therapies are indicated. For patients with non-squamous histology, actionable driver mutation testing results are required before randomization.\n* Has received any prior therapy for NSCLC in the metastatic setting.\n* Concurrent enrollment in another clinical study, unless patient is enrolled in a non-interventional clinical study or is completing survival follow -up.\n* Known actionable genomic alterations for which first-line approved therapies are indicated\n* Symptomatic CNS metastases, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to randomization, potential need for CNS radiation within the first cycle, or leptomeningeal disease\n* Other prior malignancy (including previously treated NSCLC) unless the patient has undergone curative therapy with no evidence of recurrence of the disease for 3 years prior to randomization\n* Active autoimmune or lung disease requiring systemic therapy\n* Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE version 5\n* Severe infection within 4 weeks prior to randomization\n* Major surgical procedures or serious trauma within 4 weeks prior to randomization\n* History of noninfectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease",{"count":109,"type":21},[24],"Clinical study of ivonescimab for first-line treatment of metastatic NSCLC patients with high PD-L1. Evaluating overall survival and progression free survival.",[196],{"date":202,"type":32},{"date":480,"type":32},"2025-02-27",{"date":482,"type":21},"2029-06",{"name":484,"class":39},"Summit Therapeutics",274,{"id":487,"slug":488,"hasResults":12,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":4,"eligibilityCriteria":492,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":493,"targetDuration":4,"studyType":22,"phases":495,"briefSummary":496,"conditions":497,"keywords":506,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":514,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":519,"locationsCount":521},"100525326","phase-1-bgb-43395-alone-or-as-part-of-combination-therapies-in-participants-with-breast-cancer-and-other-advanced-solid-tumors-100525326","NCT06120283","BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors","A Phase 1a\u002F1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the CDK4 Inhibitor BGB-43395, Alone or as Part of Combination Therapies in Patients With Metastatic HR+\u002FHER2- Breast Cancer and Other Advanced Solid Tumors","Inclusion Criteria:\n\n* Phase 1a (Dose Escalation): Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors associated with dependency on CDK4, including HR+ breast cancer, ovarian cancer, endometrial cancer, non-small cell lung cancer, and others. For combination with elacestrant, participants must have received at least 1 prior line of treatment for advanced\u002Fmetastatic disease including prior endocrine therapy and CDK4\u002F6 inhibitor in either the adjuvant or advanced\u002Fmetastatic setting.\n* Phase 1a Safety Expansion: For combination with fulvestrant in regions where approved and available, participants with HR+ breast cancer must have received at least 1 prior line of treatment including endocrine therapy and a CDK4\u002F6 inhibitor. For combination with letrozole, participants must be CDK4\u002F6 inhibitor treatment naïve and have not received any previous systemic treatment for advanced disease.\n* Phase 1b: Participants with HR+\u002FHER2- breast cancer.\n* Phase 1b: For combination with fulvestrant, participants with HR+\u002FHER2- breast cancer enrolled in regions where CDK4\u002F6 inhibitors are approved and available must have received 1-2 lines of therapy for advanced\u002Fmetastatic disease including endocrine therapy and a CDK4\u002F6 inhibitor. Participants can have received up to 2 lines of prior cytotoxic chemotherapy for advanced disease. Prior cytotoxic treatment is prohibited. For combination cohorts with letrozole, participants must be CDK4\u002F6 inhibitor treatment naïve and have not received any previous systemic treatment for advanced disease.\n* Stable Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.\n* Female participants with metastatic HR+\u002FHER2- breast cancer must be postmenopausal or receiving ovarian function suppression treatment.\n* Adequate organ function without symptomatic visceral disease.\n\nExclusion Criteria:\n\n* Known leptomeningeal disease or uncontrolled, untreated brain metastases.\n* Any malignancy ≤ 3 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).\n* Uncontrolled diabetes.\n* Infection requiring systemic antibacterial, antifungal, or antiviral therapy ≤ 28 days before the first dose of study drug(s), or symptomatic COVID-19 infection.\n* Participants with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV DNA ≥ 500 IU\u002FmL (or ≥ 2500 copies\u002FmL) at screening.\n* Participants with active hepatitis C infection.\n* Prior allogeneic stem cell transplantation, or organ transplantation.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":494,"type":21},399,[270],"This is a dose escalation and dose expansion study to compare how well BGB-43395, a selective cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with fulvestrant, letrozole, or elacestrant in participants with hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) breast cancer (BC) and other advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-43395.",[498,499,500,501,502,503,504,505,27],"Advanced Solid Tumor","Advanced Breast Cancer","Metastatic Breast Cancer","Hormone-receptor-positive Breast Cancer","Hormone Receptor Positive Breast Carcinoma","Hormone Receptor Positive Malignant Neoplasm of Breast","HER2-negative Breast Cancer","Hormone Receptor Positive HER-2 Negative Breast Cancer",[507,508,509,510,511,505,512,513],"breast cancer","advanced solid tumor","advanced breast cancer","hormone receptor positive breast cancer","HER2-negative breast cancer","BGB-43395","non-small cell lung cancer",{"date":202,"type":32},{"date":516,"type":32},"2023-12-01",{"date":518,"type":21},"2028-11",{"name":520,"class":39},"BeOne Medicines",62,{"id":523,"slug":524,"hasResults":12,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":528,"eligibilityCriteria":529,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":530,"targetDuration":4,"studyType":22,"phases":532,"briefSummary":533,"conditions":534,"keywords":540,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":548,"lastUpdatePostDateStruct":549,"startDateStruct":550,"completionDateStruct":552,"leadSponsor":554,"locationsCount":237},"100652721","phase-3-study-of-pembrolizumab--pemetrexed--platinum-chemotherapy-with-or-without-zoldonrasib-as-first-line-treatment-in-metastatic-non-squamous-ras-g12d-mutated-nsclc-100652721","NCT07777822","Study of Pembrolizumab + Pemetrexed + Platinum Chemotherapy With or Without Zoldonrasib as First Line Treatment in Metastatic Non-squamous RAS G12D-Mutated NSCLC","A Randomized, Double-blind, Phase 3 Study of Pembrolizumab + Pemetrexed + Platinum Chemotherapy With or Without Zoldonrasib (RMC-9805) as First Line Treatment in Patients With Metastatic Non-squamous RAS G12D-Mutated Non-small Cell Lung Cancer (RASolve 308)","RASolve 308","Inclusion Criteria:\n\n* At least 18 years old and has provided informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Histologically or cytologically confirmed, previously untreated metastatic non-squamous NSCLC.\n* Known PD-L1 status\n* Documented RAS G12D mutation status.\n* Measurable disease per RECIST v1.1.\n* Adequate organ function (bone marrow, liver, kidney, coagulation, thyroid).\n* Able to take oral medications.\n\nExclusion Criteria:\n\n* Prior treatment with systemic anticancer therapy in metastatic setting for NSCLC.\n* Prior systemic therapy with any RAS-directed therapy.\n* Untreated (symptomatic or asymptomatic) central nervous system metastatic disease.\n* Any conditions that may affect the ability to take or absorb study drug.\n* Major surgery on or within 28 days prior to randomization.\n* Patient is unable or unwilling to comply with protocol-required study visits or procedures.\n* Additional inclusion and exclusion criteria may apply",{"count":531,"type":21},430,[24],"The purpose of this study is to evaluate the efficacy of an investigational RAS(ON) inhibitor administered in combination with pembrolizumab and platinum-based chemotherapy doublet compared to placebo in combination with pembrolizumab and platinum-based chemotherapy doublet.",[287,27,535,536,537,538,539],"Non-Small Cell Lung Cancer NSCLC","Non-Squamous Non Small Cell Lung Cancer","Lung Cancer (NSCLC)","Metastatic NSCLC - Non-Small Cell Lung Cancer","Metastatic Non-Squamous Non-Small Cell Lung Cancer",[287,196,536,539,541,542,543,544,545,161,546,547],"RAS","KRAS","NRAS","HRAS","RAS Mutation","G12D","RAS G12D","2026-08-17",{"date":29,"type":32},{"date":551,"type":32},"2026-08-14",{"date":553,"type":21},"2031-02",{"name":555,"class":39},"Revolution Medicines, Inc.",{"id":557,"slug":558,"hasResults":12,"nctId":559,"briefTitle":560,"officialTitle":561,"acronym":562,"eligibilityCriteria":563,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":564,"enrollmentInfo":565,"targetDuration":4,"studyType":22,"phases":566,"briefSummary":567,"conditions":568,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":548,"lastUpdatePostDateStruct":570,"startDateStruct":571,"completionDateStruct":573,"leadSponsor":575,"locationsCount":325},"100463681","phase-3-blood-brain-barrier-bbb-opening-using-exablate-focused-ultrasound-with-standard-of-care-treatment-of-nsclc-brain-mets-100463681","NCT05317858","Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets","A Randomized Pivotal Study Assessing the Safety and Efficacy of Targeted Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound During the Standard of Care Treatment of Brain Metastases of Non-small Cell Lung Cancer (NSCLC) Origin","LIMITLESS","Inclusion Criteria:\n\n* Participant is ≥ 18 years of age\n* The participant provides written informed consent for the trial\n* Participant is willing to comply with all study procedures for the duration of the study\n* Participant has a Karnofsky Performance Status ≥ 70% and\u002For ECOG 0-2\n* Participant is a NSCLC subject prescribed immune checkpoint inhibitor systemic therapy according to on-label use with the target brain lesion(s) measuring ≥ 0.5 cm in longest diameter. Target mets may include: De novo mets for which surgery and radiation can be deferred, Mets with or without history of prior radiation, Mets with history of radiation after at least 8 weeks since last radiation treatment, and In the event a previously treated met has progressed according to institutional practice within 4 weeks post radiation treatment, the met may be study eligible, and\u002For if in the opinion of the Investigator, the subject may benefit from the study procedure.\n* Female subject is not planning pregnancy during the study duration and confirmed NOT PREGNANT each procedure day.\n* Screening\u002FBaseline laboratory values Screening\u002FBaseline should adhere to local standard of care lab values for ICI therapy\n\nExclusion Criteria\n\n* Participant has evidence of acute intracranial hemorrhage\n* Participant at risk for spontaneous intracranial hemorrhage (e.g., history of metastatic melanoma or other tissue histology).\n* Participant has signs and symptoms of increased intracranial pressure or symptomatic mass effect, midline shift or evidence of subfalcine, uncal or tonsillar herniation.\n* Participant receiving Bevacizumab (Avastin) therapy, or other drugs with a proclivity for causing bleeding.\n* History of bleeding disorders or tissue pathologies which increase the subject's risk of hemorrhage for anticoagulation medications, implement pre-surgical standard procedure to avoid increased risk of a bleeding event.\n* Participant has an infectious viral infection such as active Hepatitis B, Hepatitis C or detectable HIV viral load or participants with active bacterial infection such as TB (Bacillus tuberculosis) that may, in the opinion of the investigator, interfere with the subject receiving the study therapy or procedures or otherwise impact their participation in the trial.\n* Subjects with evidence of cranial or systemic infection.\n* Participant has received a solid organ or hematopoietic stem cell transplant.\n* Participant has received a live vaccine within 28 days prior to the first on-study ICI infusion with or without Exablate.\n* Known sensitivity to DEFINITY® ultrasound contrast agent or hypersensitivity to perflutren microsphere or its components, e.g., polyethylene glycol, as found in MiraLAX and bowel prep products.\n* Contraindications to MRI and gadolinium-DTPA including non-MRI-compatible implanted devices, severe claustrophobia, unable to lie supine in MRI.\n* Subjects with significant liver dysfunction, (cirrhosis, hemochromatosis, severe alcohol abuse, or active hepatitis (autoimmune or infectious))\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first on-study ICI infusion with or without Exablate. Note: prophylactic steroid use for ICI and chemotherapy infusion per institutional practice is allowed per protocol.\n* Has a known additional malignancy that requires active treatment that would interfere with study procedures.\n* Known presence of leptomeningeal disease.\n* Has a diagnosis of active autoimmune disease (e.g., autoimmune Hepatitis, Guillain-Barre Syndrome, etc.) requiring systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. History of (non-infectious) pneumonitis that requires steroids or has current pneumonitis\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n* Subject is currently enrolled in another intervention based clinical trial","100 Years",{"count":413,"type":21},[24],"The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier opening with Exablate Model 4000 Type 2.0\u002F2.1 for the treatment of NSCLC brain metastases in patients who are undergoing planned FDA approved, on-label systemic therapy utilizing immune checkpoint inhibitors.",[569,113],"Brain Tumor",{"date":202,"type":32},{"date":572,"type":32},"2022-08-12",{"date":574,"type":21},"2027-12-01",{"name":576,"class":39},"InSightec",{"id":578,"slug":579,"hasResults":12,"nctId":580,"briefTitle":581,"officialTitle":582,"acronym":4,"eligibilityCriteria":583,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":564,"enrollmentInfo":584,"targetDuration":4,"studyType":22,"phases":585,"briefSummary":587,"conditions":588,"keywords":591,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":548,"lastUpdatePostDateStruct":605,"startDateStruct":606,"completionDateStruct":608,"leadSponsor":610,"locationsCount":612},"100311904","phase-4-dabrafenib-andor-trametinib-rollover-study-100311904","NCT03340506","Dabrafenib and\u002For Trametinib Rollover Study","Open Label, Multi-center Roll-over Study to Assess Long Term Safety in Patients Who Have Completed a Global Novartis or GSK Sponsored Dabrafenib and\u002For Trametinib Study","Inclusion Criteria:\n\n* Patient is currently receiving treatment with dabrafenib\u002Ftrametinib monotherapy or combination within a Novartis or former GSK sponsored study which has fulfilled the requirements for the primary objective.\n* In the opinion of the Investigator would benefit from continued treatment.\n\nExclusion Criteria:\n\n* Patient has been previously permanently discontinued from study treatment in the parent protocol.\n* Patient's indication is commercially available and reimbursed in the local country.\n* Patient currently has unresolved toxicities for which dabrafenib and\u002For trametinib dosing has been interrupted in the parent study.",{"count":191,"type":21},[586],"PHASE4","This study is to provide access for patients who are receiving treatment with dabrafenib and\u002For trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.",[454,113,273,589,590],"Rare Cancers","High Grade Glioma",[592,593,594,595,596,454,597,598,599,161,600,113,601,602,603,604,590],"Tafinlar","Mekinist","Dabrafenib","Trametinib","Adult","Melanoma Stage IV","Metastatic Melanoma","Advanced Melanoma","NSLC","BRAF V600 Mutation","BRAF Gene Mutation","Solid tumor","Rare cancers",{"date":397,"type":32},{"date":607,"type":32},"2018-01-26",{"date":609,"type":21},"2032-12-28",{"name":611,"class":39},"Novartis Pharmaceuticals",33,{"id":614,"slug":615,"hasResults":12,"nctId":616,"briefTitle":617,"officialTitle":618,"acronym":4,"eligibilityCriteria":619,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":620,"targetDuration":4,"studyType":22,"phases":621,"briefSummary":622,"conditions":623,"keywords":624,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":631,"lastUpdatePostDateStruct":632,"startDateStruct":633,"completionDateStruct":635,"leadSponsor":637,"locationsCount":237},"100555587","phase-2-study-of-bebt-109-in-subjects-with-non-small-cell-lung-cancer-carrying-egfr-exon-20-insertion-mutations-100555587","NCT06514027","Study of BEBT-109 in Subjects With Non-Small Cell Lung Cancer Carrying EGFR Exon 20 Insertion Mutations","A Multicenter, Open Phase II Clinical Study on the Safety and Efficacy of BEBT-109 Combined With Chemotherapy as First-Line Treatment for Non-Small Cell Lung Cancer Carrying EGFR Exon 20 Insertion Mutations","Inclusion Criteria:\n\n1. Participants have a comprehensive understanding, voluntarily sign the Informed Consent Form (ICF), and are capable of completing all trial procedures;\n2. Age ≥18 years old, both males and females are eligible;\n3. According to the 8th edition of the American Joint Committee on Cancer（AJCC）TNM staging criteria for lung cancer: patients with histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC) that is unresectable and intolerant or refuses radical synchronous radiochemotherapy, with locally advanced (stage IIIB or IIIC), recurrent, or metastatic (stage IV) disease;\n4. No prior systemic treatment for locally advanced (stage IIIB or IIIC) or recurrent\u002Fmetastatic (stage IV) NSCLC. Note: 1) Neoadjuvant\u002Fadjuvant therapy is allowed as long as it has been completed at least 6 months before the disease is diagnosed as locally progressive or metastatic tumor; 2) Participants who have failed treatment with savolitinib in the past are allowed;\n5. EGFR exon 20 insertion mutations confirmed by peripheral blood or tumor tissue testing conducted by a tertiary hospital or a qualified third-party testing agency, and records must be provided. Patients may have only EGFR exon 20 insertion mutations or may also have other EGFR or HER2 mutations;\n6. At least one measurable lesion that meets the RECIST V1.1 criteria during the screening period. Lesions previously treated with radiotherapy cannot be used as target lesions unless there is clear radiological progression after radiotherapy;\n7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1, and no decline in performance status within two weeks before the screening period, with an expected survival time ≥12 weeks;\n8. Provided that the subject has not received blood transfusion, erythropoietin, recombinant human thrombopoietin, or colony-stimulating factor treatment within 14 days before the screening period, laboratory tests indicate that the subject has adequate organ function, including:\n\n   * Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL; Platelet count (PLT) ≥100×10\\^9\u002FL; Hemoglobin (HGB) ≥90 g\u002FL;\n   * Total serum bilirubin (TBIL) ≤1.5×upper limit of normal (ULN) (for patients with Gilbert's syndrome, total bilirubin ≤3×ULN is allowed);\n   * AST and ALT ≤2.5×ULN (for those with liver metastasis, AST and ALT ≤5×ULN is allowed);\n   * Creatinine clearance ≥45 ml\u002Fmin (calculated according to the Cockcroft-Gault formula), and urine protein ≤1+ or for subjects with urine protein ≥2+, the 24-hour urine protein total is ≤1 g\u002F24 h;\n   * Activated partial thromboplastin time (APTT) ≤1.5×ULN, prothrombin time (PT) ≤1.5×ULN, international normalized ratio (INR) ≤1.5×ULN;\n9. Participants with a history of liver cirrhosis have a Child-Pugh score of A or B ≤7 at screening;\n10. The QT interval evaluated by ECG at screening is normal, defined as the corrected QT interval (Fridericia) (QTcF) ≤450 ms (for males) or ≤470 ms (for females) (those not meeting the standard need to be retested twice, and the average corrected value of the three measurements is taken);\n11. Male and female participants of childbearing potential must agree to use reliable contraceptive methods (hormonal or barrier methods) during the study period and for at least 6 months after the last administration of the drug, and must not breastfeed, with a negative blood pregnancy test before the first administration.\n\nExclusion Criteria:\n\n1. History of severe allergic diseases (such as uncontrollable asthma), severe drug (including investigational drugs not yet marketed) allergies, or known allergies or intolerance to any drug or drug component in this study;\n2. Diagnosis of other primary malignant tumors besides NSCLC, except for the following: non-melanoma skin cancer or cervical carcinoma in situ that has been adequately treated and cured, non-metastatic prostate cancer, or other primary malignant tumors that have been clearly recurrence-free for at least 3 years since the last treatment and have a low potential risk of recurrence;\n3. Major surgical procedures within 28 days before the first administration of the study drug, planned surgery during the study period, or postoperative complications from surgery performed within 2 months before the first administration of the study drug (except for minor surgeries that the investigator deems do not affect participation in the trial, such as catheter placement or minimally invasive biopsy);\n4. Presence of pleural effusion, ascites, or pericardial effusion with significant symptoms or requiring drainage;\n5. Poorly controlled diabetes mellitus. Definition: Hemoglobin A1C (HbA1c) ≥8%; or 7% ≤ Hemoglobin A1C \\\u003C 8%, accompanied by clinical symptoms of diabetes, such as polyuria, polydipsia, polyphagia, and weight loss. (Subjects who have not been adequately treated to control blood sugar, after adjusting the drug treatment plan, with fasting blood glucose ≤10 mmol\u002FL, and deemed suitable to participate in this study by the investigator, can be included);\n6. Received live vaccines within 28 days before the first administration of the study drug or plan to receive any live vaccines during the study period;\n7. Subjects with a tendency to bleed or evidence of bleeding, including:\n\n   1. History of active ulcers or perforations of the stomach and duodenum within 6 months before the first dose, persistent positive fecal occult blood, history of gastrointestinal bleeding such as ulcerative colitis;\n   2. History of hemoptysis (defined as blood that is bright red or 2.5 ml) within 2 weeks before the first dose, or the presence of unhealed wounds, ulcers, or fractures;\n   3. Vasculitis;\n   4. Other conditions that may cause bleeding as determined by the investigator;\n8. Presence of severe gastrointestinal functional abnormalities that may affect the intake, transport, or absorption of the test drug (such as inability to swallow, uncontrollable vomiting, history of extensive gastrointestinal resection, chronic diarrhea, long-term use of proton pump inhibitors (PPIs) for gastric diseases, Crohn's disease, ulcerative colitis, intestinal obstruction, etc.);\n9. Presence of central nervous system (CNS) metastasis, except for those who are asymptomatic, have stable disease, and do not require drug treatment within 4 weeks before the start of the study treatment;\n10. Current spinal cord compression (symptomatic or asymptomatic, and detected by radiographic examination) or suspected meningeal disease (symptomatic or asymptomatic);\n11. Imaging (CT or MRI) shows that the tumor invades major blood vessels or is not clearly demarcated from major blood vessels;\n12. Significant clinical cardiovascular and cerebrovascular diseases within 6 months before the first study drug administration, including but not limited to:\n\n    e. Acute myocardial infarction, unstable angina; f. New York Heart Association (NYHA) class III or IV congestive heart failure; g. Left ventricular ejection fraction \\\u003C50% measured by echocardiography or multigated acquisition (MUGA) scan or with severe wall motion abnormalities; h. History of clinically significant ventricular arrhythmias (such as sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes); i. Subjects with poorly controlled hypertension, with systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg; j. Arterial\u002Fvenous thrombotic events, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism; low molecular weight heparin treatment is allowed, and the use of nonsteroidal anti-inflammatory drugs (NSAIDs) or antiplatelet drugs (such as aspirin (\\>325 mg\u002Fday), clopidogrel (\\>75 mg\u002Fday), dipyridamole, ticlopidine, or cilostazol, etc.) is prohibited throughout the study period; k. Other arrhythmias deemed unsuitable for inclusion in this study by the investigator (such as third-degree atrioventricular block);\n13. Presence of other severe or uncontrolled diseases that the investigator deems unsuitable for participation in this clinical trial or may affect the subject's compliance with the study protocol, including but not limited to:\n\n    1. Interstitial lung disease, radiation pneumonitis or drug-related pneumonitis requiring steroid treatment;\n    2. History of uncontrolled hereditary or acquired thrombotic diseases;\n    3. Persistent or active infections, including but not limited to: hepatitis B virus (meeting both hepatitis B surface antigen positive or hepatitis B e antigen positive, and HBV-DNA greater than the upper limit of normal of the center's laboratory), hepatitis C virus (meeting both HCV-Ab positive and HCV-RNA positive), human immunodeficiency virus (HIV-Ab positive), syphilis non-specific antibody positive (rapid plasma reagin \\[RPR\\] or toluidine red unheated serum test \\[TRUST\\]) without clinical symptoms, or other active infections that require systemic treatment within 14 days before the first study drug administration;\n    4. Severe or unhealed wounds, ulcers, or fractures;\n14. History of drug or alcohol abuse or mental illness;\n15. Use of drugs or herbal supplements that are strong inhibitors or inducers of CYP 3A4 and CYP 2C8 within 14 days before the first administration of the study drug ;\n16. Received \\>30Gy of non-thoracic radical radiotherapy within 28 days before the first dose, \\>30Gy of thoracic radiotherapy within 24 weeks before the first dose, and ≤30Gy of palliative radiotherapy within 14 days before the first dose;\n17. Participation in another clinical trial and drug administration within 4 weeks before the first dose;\n18. Other conditions deemed unsuitable for entry into this study by the investigator.",{"count":413,"type":21},[157],"This is a multicenter, open Phase II clinical study to evaluate the efficacy, safety, and pharmacokinetic characteristics of BEBT-109 combined with injectable pemetrexed disodium and carboplatin or cisplatin injection as first-line treatment for locally advanced, recurrent, or metastatic non-small cell lung cancer carrying EGFR exon 20 insertion mutations.",[113],[625,626,627,628,629,630],"BEBT-109","EGFR exon 20 insertion mutations","Drug combination","First-line treatment","Safety","Efficacy","2026-08-16",{"date":397,"type":32},{"date":634,"type":32},"2024-08-28",{"date":636,"type":21},"2027-11",{"name":638,"class":39},"BeBetter Med Inc"]