[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"small-cell-lung-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:small-cell-lung-cancer":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,120,0,25,[9,46,75,119,145,171,197,224,249,270,292,319,356,381,403,471,498,528,553,577,599,617,640,661,698],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100652949","phase-3-phase-3-trial-of-tarlatamab-sc-vs-iv-in-extensive-stage-small-cell-lung-cancer-after-platinum-based-first-line-chemotherapy-es-sclc-100652949",false,"NCT07778316","Phase 3 Trial of Tarlatamab (SC vs IV) in Extensive-Stage Small Cell Lung Cancer After Platinum Based First-line Chemotherapy (ES-SCLC)","A Phase 3, Open-Label, Multicenter, Randomized Study of Subcutaneous vs Intravenous Tarlatamab in Participants With Relapsed Extensive-Stage Small Cell Lung Cancer After Platinum-based First-line Chemotherapy (DeLLphi-315)","DeLLphi-315","Inclusion Criteria:\n\n* Participant has provided informed consent prior to initiation of any study specific activities\u002Fprocedures.\n* Age ≥ 18 years (or legal adult age within country, whichever is older) at the time of signing the informed consent.\n* Histologically or cytologically confirmed SCLC with demonstrated progression or relapse.\n* Participants who progressed or recurred following 1 platinum-based regimen.\n* Measurable disease as defined per RECIST 1.1 within the 21-day screening period.\n* Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.\n* Minimum life expectancy of 12 weeks.\n* Adequate organ function.\n* History of central nervous system (CNS) metastases are allowed with considerations defined in the protocol.\n\nExclusion Criteria:\n\nDisease Related\n\n\\- Any previous diagnosis of non-small cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation that has transformed to SCLC, or mixed SCLC and NSCLC histology, with exceptions defined in the protocol.\n\nOther Medical Conditions\n\n* Myocardial infarction and\u002For symptomatic congestive heart failure (New York Heart Association \\> class II) within 6 months prior to first dose of study treatment.\n* History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 6 months prior to first dose of study treatment.\n* Current evidence or history of non-infectious pneumonitis\u002FILD (interstitial lung disease) that required steroids or other immunosuppressive treatment.\n* History of other malignancy within the past 2 years, with exceptions defined in the protocol.\n* Presence or history of viral infection based on criteria per protocol.\n* History of solid organ transplantation.\n* Symptoms and\u002For radiographic signs that indicate an acute and\u002For uncontrolled active systemic infection requiring antibiotics within 7 days prior to the first dose study treatment.\n* Known sensitivity or a contraindication to any of the products or components.\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.\n\nPrior\u002FConcomitant Therapy\n\n* Prior systemic anticancer therapy within 30 days of enrolment\n* Prior history of severe or life-threatening events from any immune-mediated therapy.\n* Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 14 days prior to first dose of study treatment.\n* Live and live-attenuated vaccines within 28 days prior to the start of study treatment.\n* Receiving another anticancer therapy for a malignancy other than SCLC.\n* More than 1 prior line of anticancer therapy for SCLC.\n* Participation in a tarlatamab clinical trial or prior therapy with any selective inhibitor of the delta-like ligand 3 (DLL3) pathway.\n* Treatment in an alternative investigational trial within 28 days prior to enrolment.\n* History of allergy or hypersensitivity to similar products (eg, drugs with a similar chemical structure or other monoclonal antibody) or any excipient.\n\nOther Exclusions\n\n* Participants unable to have SC injections administered in the abdomen or thigh.\n* Participant unlikely to be able to complete all protocol-required procedures, restrictions and requirements.\n* History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to participant safety.","ALL","18 Years","99 Years",{"count":22,"type":23},400,"ESTIMATED","INTERVENTIONAL",[26],"PHASE3","The primary objective of this study is to demonstrate non-inferiority in pharmacokinetic (PK) parameters of subcutaneous (SC) vs intravenous (IV) tarlatamab administration and to characterize the efficacy, safety, and tolerability of SC tarlatamab in participants with relapsed extensive-stage small-cell lung cancer (ES-SCLC) after platinum-based chemotherapy.",[29],"Small Cell Lung Cancer",[31,32],"Tarlatamab","ES-SCLC","RECRUITING","2026-08-20",{"date":36,"type":37},"2026-08-21","ACTUAL",{"date":39,"type":23},"2026-08-31",{"date":41,"type":23},"2030-07-30",{"name":43,"class":44},"Amgen","INDUSTRY",2,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":54,"targetDuration":4,"studyType":24,"phases":56,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100633777","phase-1-study-of-tarlatamab--zl-1310---anti-programmed-death-ligand-1-anti-pd-l1-in-small-cell-lung-cancer-sclc-100633777","NCT07531095","Study of Tarlatamab + ZL-1310 +\u002F- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)","A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination With ZL-1310 With or Without Anti-PD-L1 in Participants With Small Cell Lung Cancer","DeLLphi-313","Inclusion Criteria:\n\n* Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent.\n* Participants with Histologically or cytologically confirmed SCLC:\n* For Part 1, participants must have SCLC that has progressed or recurred following at least 1 line of platinum-based anti-cancer therapy.\n* For Parts 1 and 2, participants must have progressed or recurred following at least 1 line of platinum-based therapy. No prior tarlatamab is allowed in Cohort 2-1.\n* For Part 3, participants must have extensive-stage SCLC (ES-SCLC) with no prior systemic treatment other than 1 cycle of platinum-based chemotherapy.\n\nNote: Participants with prior treatment for limited-stage SCLC (LS-SCLC) before diagnosis of ES SCLC are permitted.\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* At least 1 measurable lesion as defined per RECIST v1.1 within 21-day screening period, not previously irradiated.\n* Adequate organ function (hematological, coagulation, renal, hepatic, pulmonary, and cardiac function).\n\nExclusion Criteria:\n\n* Symptomatic CNS metastases. Participants with treated brain metastases are eligible provided they meet the criteria specified in the protocol.\n* History of interstitial lung disease (ILD)\u002Fpneumonitis.\n* Received thoracic radiation therapy within 90 days prior to first dose of trial intervention.\n* Prior therapy with any delta-like ligand 3 (DLL3)-directed therapy.\n* Prior exposure to topoisomerase I inhibitors or antibody-drug conjugate (ADC) with topoisomerase I inhibitor payload.\n* Receiving strong CYP3A4 or CPY2D6 inhibitors within 14 days or 5 half-lives (whichever is longer) before the first dose of trial treatment.\n* Enrollment in any tarlatamab clinical trial.",{"count":55,"type":23},160,[57],"PHASE1","The primary objective of this trial is to evaluate the safety and tolerability of tarlatamab in combination with ZL-1310 with or without durvalumab and to determine the maximum tolerated combination dose (MTCD) and\u002For recommended phase 2 dose (RP2D) of ZL-1310 in combination with tarlatamab.",[29],[31,61,62,63,64,65,66,67],"ZL-1310","Durvalumab","SCLC","Anti-PD-L1","Extensive Stage Small Cell Lung Cancer","Programmed death protein-1 (PD-1)","Programmed death ligand 1 (PD-L1)",{"date":36,"type":37},{"date":70,"type":37},"2026-04-21",{"date":72,"type":23},"2031-05-21",{"name":43,"class":44},27,{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":24,"phases":85,"briefSummary":86,"conditions":87,"keywords":100,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":118},"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":84,"type":23},299,[57],"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.",[88,89,90,91,92,93,94,95,96,97,98,99],"Solid Tumor","Non-small Cell Lung Cancer","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",[101,102,89,103,90,104,91,105,106,92,93,107,94,95,96,97,108,98,99,109],"HH160","PD-1×CTLA-4×VEGF-A Antibody","NSCLC","HCC","CRC","GEA","RCC","TNBC","Ovarian Cancer","2026-08-19",{"date":36,"type":37},{"date":113,"type":37},"2026-06-11",{"date":115,"type":23},"2028-08",{"name":117,"class":44},"Huahui Health",3,{"id":120,"slug":121,"hasResults":12,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":24,"phases":128,"briefSummary":129,"conditions":130,"keywords":131,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":137,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":144},"100621024","phase-3-a-study-to-evaluate-adverse-events-and-change-in-disease-activity-of-intravenous-abbv-706-versus-standard-of-care-in-adult-participants-with-relapsedrefractory-small-cell-lung-cancer-100621024","NCT07365241","A Study to Evaluate Adverse Events and Change in Disease Activity of Intravenous ABBV-706 Versus Standard of Care in Adult Participants With Relapsed\u002FRefractory Small Cell Lung Cancer","A Phase 3 Randomized, Open Label, Multicenter Study to Evaluate the Safety and Efficacy of ABBV-706 Versus Standard of Care in Subjects With Relapsed\u002FRefractory Small Cell Lung Cancer (SCLC)","Inclusion Criteria:\n\n* Diagnosis of histologically or cytologically confirmed Relapsed\u002FRefractory (R\u002FR) Small Cell Lung Cancer (SCLC).\n* Participants must have progressed on prior systemic therapy, with CPI (if eligible) and prior tarlatamab, defined as:\n\n  * In the 1L and 2L setting respectively, platinum-based chemotherapy (i.e., carboplatin or cisplatin and etoposide with CPI, if eligible for CPI) and 2L tarlatamab; or\n  * In the 1L and 2L setting, platinum-based chemotherapy (i.e., carboplatin and etoposide with atezolizumab and lurbinectedin in combination with atezolizumab maintenance and 2L tarlatamab; or\n  * In the 1L setting, platinum-based chemotherapy (i.e., carboplatin or cisplatin and etoposide with CPI if eligible) in combination with tarlatamab in frontline induction and\u002For maintenance\n* Participants must be considered suitable to receive SOC comparator (topotecan, lurbinectedin, or amrubicin).\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 during the screening period prior to the first dose of study treatment.\n* Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n* Participants with brain metastasis from an extracranial solid tumor are eligible if the brain metastases are:\n\n  * Previously treated and not requiring anticonvulsants and steroids for at least 7 days prior to first dose of study treatment. If required for management, subjects on a steroid equivalent of prednisone dose of ≤ 10 mg\u002Fday are eligible or;\n  * Untreated and asymptomatic not requiring anticonvulsants and steroids for at least 7 days prior to the first dose of study treatment. If required for management, subjects on a steroid equivalent of prednisone of ≤ 10 mg\u002Fday are eligible.\n\nExclusion Criteria:\n\n* Participants with known active\u002Fsymptomatic central nervous system metastases.\n* Participants with a history of interstitial lung disease (ILD) or pneumonitis that previously required treatment with systemic steroids, or any evidence of active ILD\u002Fpneumonitis on screening chest computed tomography (CT) scan.\n* Participants with any clinically significant conditions that would adversely affect the participation in the study, and the subject should have a life expectancy of at least 3 months.\n* Participants who have received prior treatment with a seizure-related 6 homolog (SEZ6) targeted Antibody drug conjugate (ADC), other targeted ADCs, or any other investigational agent not including tarlatamab in 1L.\n* Participants who have received prior treatment with any Top1i such as topotecan, irinotecan, belotecan, camptothecin, rubitecan, exatecan or locally approved topoisomerase I inhibitor (Top1i) payload.",{"count":127,"type":23},531,[26],"Small cell lung cancer (SCLC) is characterized by aggressive and rapid growth and a tendency to develop early spread to distant sites including mediastinal lymph nodes, liver, bones, adrenal glands, and brain. The purpose of this study is to assess safety, tolerability, and change in disease activity of ABBV-706 compared to standard of care (SOC) treatment (topotecan, lurbinectedin, or amrubicin).\n\nABBV-706 is an investigational drug being developed for the treatment of SCLC. There are two treatment arms in this study. Participants will either receive ABBV-706 or SOC. Approximately 531 adult participants will be enrolled in the study across 175 sites worldwide.\n\nParticipants with SCLC will receive intravenous (IV) ABBV-706 or SOC \\[topotecan (IV or orally), or lubinectedin (IV), or amrubicin (IV)\\]. The estimated duration of the study is approximately 53 months.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.",[29],[29,63,132,133,134,135,136],"ABBV-706","Topotecan","Lurbinectedin","Amrubicin","Cancer",{"date":36,"type":37},{"date":139,"type":37},"2026-07-02",{"date":141,"type":23},"2030-09",{"name":143,"class":44},"AbbVie",49,{"id":146,"slug":147,"hasResults":12,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":24,"phases":154,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":170},"100647498","phase-1-dareon-36-a-study-to-test-obrixtamig-in-combination-with-zl-1310-in-people-with-advanced-small-cell-lung-cancer-or-other-neuroendocrine-cancers-100647498","NCT07707895","DAREON®-36: A Study to Test Obrixtamig in Combination With ZL-1310 in People With Advanced Small Cell Lung Cancer or Other Neuroendocrine Cancers","A Phase Ib\u002FII, Open-label, Safety and Tolerability Trial of Obrixtamig in Combination With ZL-1310 in Patients With Poorly Differentiated NEC","Inclusion criteria:\n\nFor Part 1\n\n1. Diagnosed with locally advanced, metastatic or relapsed cancer of the following histologies:\n\n   * Small cell lung carcinoma (SCLC)\n   * Large cell neuroendocrine lung carcinoma (LCNEC-L)\n   * Extrapulmonary neuroendocrine carcinoma (epNEC) of small or large cell histology\n2. Patients with tumours with mixed histologies for any above type are eligible only if the neuroendocrine carcinoma\u002Fsmall cell component is predominant and represents at least 50% of the overall tumour tissue\n3. Patients for whom no therapy of proven efficacy exists or who are not eligible for established treatment options. Patients must have exhausted available treatment options known to prolong survival for their disease. Previous therapies should include at least one line of platinum-based chemotherapy, unless there is a documented medical reason not to use platinum\n\n   For Part 2\n4. Histologically or cytologically confirmed extended stage small cell lung cancer (ES-SCLC) (excluding combined histologies) using the American Joint Committee on Cancer (AJCC) tumour node metastasis staging system combined with Veterans Administration Lung Study Group (VALG)'s two stage classification scheme.\n5. Patients must have received no prior systemic therapy for ES-SCLC. Participants with prior chemoradiotherapy for Limited stage small cell lung cancer (LS-SCLC) must have been treated with curative intent and had a treatment-free interval of at least 6 months after the last chemotherapy, radiotherapy, or chemoradiotherapy before diagnosis of ES-SCLC to be eligible\n\n   For both Part 1 and Part 2\n6. Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses\n7. Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the informed consent form (ICF)\n8. Willing and able to comply with scheduled visits, treatment schedule, the planned trial assessments, laboratory tests, restrictions regarding prohibited medications, lifestyle restrictions, and other requirements related to the trial. This includes that they are able to understand and follow trial-related instructions\n9. Further inclusion criteria apply.\n\nExclusion criteria:\n\n1. Serious concomitant disease or medical condition such as neurologic, psychiatric (including substance use disorder), active ulcers (gastrointestinal tract or skin) or laboratory abnormalities that may negatively impact patient safety during trial participation, affect compliance with trial requirements or invalidate assessments relevant for the investigation of the safety and preliminary efficacy of the investigational drugs\n2. Patients with a diagnosis of Merkel cell carcinoma or medullary thyroid cancer\n3. Presence of leptomeningeal disease and\u002For carcinomatous meningitis\n4. Known hypersensitivity to the trial drugs or their excipients, prior severe, life-threatening hypersensitivity reaction(s) to monoclonal antibodies, or significant risk of allergic or anaphylactic reaction(s) to any of the investigated drug products according to the investigator's judgement\n5. Participants who experienced severe, life-threatening immune-mediated adverse events, e.g. serious Grade 3 or higher immune-related adverse event (imAE) or infusion-related reactions, that led to permanent discontinuation while on treatment with immuno-oncology agents\n6. Persistent toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 (except for alopecia, asthenia\u002Ffatigue, amenorrhea\u002Fmenstrual disorders, CTCAE Grade 2 peripheral neuropathy, and CTCAE Grade 2 endocrinopathies controlled by replacement therapy, and toxicities, which are considered irreversible but stable for at least 4 weeks, per investigator judgment)\n7. Therapy with any of the following types of treatments or drugs within the noted time intervals prior to IMP administration: At any time: treatment with delta-like ligand 3 (DLL3)-targeting therapies or received more than 30 Gy of thoracic radiotherapy.\n8. Prior organ or tissue allograft\n9. Further exclusion criteria apply.",{"count":153,"type":23},60,[57,155],"PHASE2","This study is open to adults with advanced small cell lung cancer and other neuroendocrine cancers. The study has 2 parts. The purpose of Part 1 is to find a suitable dose of a combination study treatment, obrixtamig and ZL-1310. The purpose of Part 2 is to see how obrixtamig and ZL-1310 is tolerated when given with another medicine called a checkpoint inhibitor. Another purpose is to check whether the study treatment can stop the cancer from growing and keep it stable. Obrixtamig and ZL-1310 are being developed to help the immune system fight cancer.\n\nIn Part 1, participants get obrixtamig and ZL-1310. In Part 2, participants get obrixtamig and ZL-1310 with a checkpoint inhibitor. Part 2 is only open to people with advanced small cell lung cancer. All study treatments are given as infusions into a vein.\n\nThe study does not have a fixed duration. Participants can receive study treatment for up to 2 years if they benefit from treatment and can tolerate it. Participants visit the study site regularly, with some overnight stays required. During this time, doctors regularly check for health problems that could be caused by the study treatment. They also monitor the size of the tumour(s) and take laboratory tests.",[29,158,159,160],"Large Cell Neuroendocrine Lung Carcinoma","Extrapulmonary Neuroendocrine Carcinoma of Small Cell Histology","Extrapulmonary Neuroendocrine Carcinoma of Large Cell Histology","NOT_YET_RECRUITING","2026-08-18",{"date":110,"type":37},{"date":165,"type":23},"2026-09-24",{"date":167,"type":23},"2030-04-26",{"name":169,"class":44},"Boehringer Ingelheim",26,{"id":172,"slug":173,"hasResults":12,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":24,"phases":180,"briefSummary":181,"conditions":182,"keywords":183,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":190,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":45},"100586988","phase-1-phase-1-trial-of-st-001-nanofenretinide-in-relapsed-refractory-small-cell-lung-cancer-100586988","NCT06922539","Phase 1 Trial of ST-001 nanoFenretinide in Relapsed\u002F Refractory Small Cell Lung Cancer","A Phase 1b Trial in Relapsed\u002FRefractory Small Cell Lung Cancer to Determine the Clinical Activity, Safety Profile, and Pharmacology of ST-001, a Fenretinide Phospholipid Suspension (12.5 mg\u002FmL) for Intravenous Infusion","Inclusion Criteria:\n\n* Small cell lung cancer (SCLC).\n* Patients must all have at least one measurable disease site using RECIST version 1.1 criteria.\n* Patients must have relapsed or refractory disease to prior treatment with platinum-based chemotherapy ± immunotherapy. There is no limit on the number of prior systemic treatment regimens.\n* Relapsed\u002Frefractory disease of any stage if incurable in nature, is eligible for enrollment.\n* Minimum of 3 weeks or 5 half-lives, whichever is shorter must have elapsed since last systemic treatment. A 1-week washout is required for palliative radiation treatment and 2-week washout is required for whole brain radiation treatment. Patients must have recovered from all clinically significant toxicity of last treatment and cleared the pharmacological agent(s) used previously.\n* ECOG performance status 0-1 (Karnofsky ≥60%).\n* Life expectancy greater than 6 months.\n* Patients must have normal organ and marrow function.\n* Triglyceride blood level (fasting) \\\u003C300mg\u002FdL at time of enrollment (normal: \\\u003C150mg\u002FdL; borderline high = 150-199mg\u002FdL; high = 200-499mg\u002FdL; very high = 500mg\u002FdL or higher).\n* Women of non-child bearing potential, that is women who have been menopausal or surgically sterile for more than 1 year, are eligible for enrolment in the study.\n* Informed consent of the patient or a legal authorized representative (LAR) must be obtained prior to any study related procedures.\n\nExclusion Criteria:\n\n* Mixed SCLC\u002FNSCLC tumors are not eligible. Pregnant or breastfeeding women cannot take part in this study. Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.\n* Patients who are receiving any other investigational agents. SCLC patients with history of CNS metastasis may be included if CNS disease is asymptomatic and controlled without progression at least 4 weeks after treatment with radiotherapy, and patient is either no longer taking corticosteroids or on a stable dose of corticosteroids.\n* History of allergic reactions or sensitivity to retinoids or to any excipients of ST-001.\n* Patients who require concurrent treatment with drugs that are strong CYP3A inducers are excluded from the trial.\n* Patients who require concurrent treatment with drugs that are strong to moderate CYP3A inhibitors are excluded from the trial.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (NY heart classification III\u002FIV), unstable angina pectoris, cardiac arrhythmia, QTc interval \\>450 milliseconds for men and \\>460 milliseconds for women on baseline triplicate ECG, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* HIV-positive patients on combination antiretroviral therapy are ineligible. Patients with any active hepatitis infections. Presence of nyctalopia (night blindness), or hemeralopia (defective vision in a bright light, 'day blindness') at enrollment, or any other retinal, ophthalmological condition (e.g.: retinitis pigmentosa, choroidoretinitis and xerophthalmia), and glaucoma.\n* History of solid tumor malignancy other than the diseases under study, diagnosed within the last three (3) years of study enrollment, excluding adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer, in situ breast cancer, in situ prostate cancer (patients must have shown no evidence of active disease for 2 years prior to enrollment).",{"count":179,"type":23},44,[57],"This study evaluates a fenretinide phospholipid suspension for the treatment of small cell lung cancer (SCLC).",[29],[184,63,185,186,187,188,189],"fenretinide","Relapsed\u002FRefractory","Relapsed\u002FRefractory SCLC","R\u002FR SCLC","ST-001","intravenous administration",{"date":110,"type":37},{"date":192,"type":37},"2025-12-11",{"date":194,"type":23},"2028-10-01",{"name":196,"class":44},"SciTech Development, Inc.",{"id":198,"slug":199,"hasResults":12,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":24,"phases":206,"briefSummary":207,"conditions":208,"keywords":214,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":219,"leadSponsor":221,"locationsCount":223},"100629562","phase-2-symbiotic-lung-14-a-study-to-learn-about-the-study-medicine-called-pf08634404-in-combination-with-chemotherapy-in-adult-participants-with-transformed-small-cell-lung-cancer-100629562","NCT07476287","Symbiotic-Lung-14: A Study to Learn About the Study Medicine Called PF08634404 in Combination With Chemotherapy in Adult Participants With Transformed Small Cell Lung Cancer","A PHASE 2 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN PARTICIPANTS WITH PREVIOUSLY UNTREATED TRANSFORMED SMALL CELL LUNG CANCER","Inclusion Criteria:\n\n* Male or female participants aged ≥18 years at the time of informed consent.\n* Histologically or cytologically confirmed T-SCLC. Participant must have had a prior diagnosis of NSCLC with EGFR mutation which transformed to SCLC following the treatment with TKI(s).\n* Participants have not received systemic therapy for T-SCLC.\n* Have at least one measurable lesion as the target lesion based on RECIST v1.1.\n* Have sufficient tumor tissue from the diagnosis of transformed SCLC available.\n* Eastern Cooperative Oncology Group performance status of 0 or 1.\n* Have a minimum life expectancy of \\>12 weeks.\n* Clinical laboratory values at screening within acceptable limits, as defined in the protocol, including: 1) Hematology, 2) Liver function and 3) Renal function.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Active or untreated CNS disease, including brain, brainstem, spinal cord, or meningeal metastases. Participants with definitively treated, clinically stable brain metastases may be eligible per protocol criteria. Participants with untreated asymptomatic brain metastases of longest diameter \\\u003C1 cm are permitted if all of the following criteria are met: absence of neurological symptoms, no need for corticosteroids, and brain metastasis has no evidence of edema or hemorrhagic features.\n* Leptomeningeal disease\n* Clinically significant risk of hemorrhage or fistula, including tumor necrosis\u002Fcavitation, invasion or compression of major blood vessels, airways, or critical organs, or risk of tracheoesophageal or pleuroesophageal fistula\n* History of another malignancy (other than NSCLC) within 3 years prior to first dose, except for malignancies with negligible risk of metastasis or death (eg, adequately treated carcinoma in situ, nonmelanoma skin cancer)\n* Unresolved toxicity from prior anti-tumor therapy that has not recovered to Grade ≤1 per NCI CTCAE v5.0 (except alopecia or irreversible toxicities deemed stable)\n* History of allogeneic organ or hematopoietic stem cell transplantation\n* Active autoimmune disease requiring systemic treatment within the past 2 years (Stable replacement therapy and selected low-risk autoimmune conditions are permitted per protocol)\n* Interstitial lung disease (ILD), pneumonitis, or significant pulmonary disease, including:\n\n  * Prior or current non-infectious pneumonitis requiring systemic therapy\n  * DLCO \\\u003C50% predicted\n  * Severe asthma, COPD, pulmonary embolism, or autoimmune lung involvement\n* Uncontrolled or clinically significant cardiovascular, cerebrovascular, metabolic, hepatic, or renal disease within 6 months prior to first dose\n* Baseline QTcF \\>480 msec\n* Major surgery or severe trauma within 4 weeks prior to first dose, or planned major surgery during the study\n* Clinically significant pleural effusion, pericardial effusion, or ascites requiring repeated drainage\n* History of significant bleeding disorders or recent major bleeding events\n* Clinically significant gastrointestinal conditions, including recent perforation, fistula, obstruction, or active bleeding\n* Active, uncontrolled, or symptomatic infection, including:\n\n  * Active TB\n  * Active hepatitis B or C\n  * Uncontrolled HIV infection\n* History of immunodeficiency\n* Severe hypersensitivity or allergic reactions to study intervention components or monoclonal antibodies\n* Psychiatric illness or medical condition, including recent suicidal ideation or behavior, that may increase risk or interfere with study participation\n* Prior anti-angiogenic therapy or other prohibited anti-tumor or immunomodulatory therapies per protocol-specified washout periods\n* Use of prohibited concomitant medications, including high-dose systemic corticosteroids, certain anticoagulants, or live vaccines within protocol-specified timeframes\n* Recent participation in another investigational study (within 30 days or 5 half-lives, whichever is longer)\n* Pregnant or breastfeeding participants, or unwillingness to comply with contraception requirements",{"count":205,"type":23},40,[155],"This study is being done to learn more about a new medicine called PF-08634404. The study team wants to understand how well PF-08634404 works when given alone or with chemotherapy . Chemotherapy is a type of cancer treatment that uses medicines to destroy cancer cells or stop them from growing. The study is for adults with Transformed Small Cell Lung Cancer (T-SCLC ). T SCLC is a rare lung cancer that happens when one type of lung cancer changes into a more aggressive type after treatment stops working.\n\nTo join the study, participants must meet the following conditions:\n\n* Are aged 18 years or older\n* Diagnosed with T-SCLC and have not received treatment for this type of lung cancer (a single cycle of chemotherapy may be permitted)\n* Prior diagnosis of epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer treated with tyrosine kinase inhibitors (TKIs)\n* Have healthy organs based on medical tests and are in good physical condition\n\nAfter joining the study, adults will be given chemotherapy in addition to the study medicine. After this combination treatment is finished, the study medicine will be continued alone. Adults will receive the treatment through IV infusions (medicine given directly into a vein). All treatments will be done at clinical study sites, where a trained medical team will monitor adults during and after each visit.",[29,209,210,211,212,213],"Small Cell Lung Cancer ( SCLC )","Transformed Small Cell Lung Cancer","Lung Neoplasms","Carcinoma, Small Cell Lung","Small Cell Cancer Of The Lung",[210,29],"2026-08-14",{"date":217,"type":37},"2026-08-17",{"date":139,"type":37},{"date":220,"type":23},"2031-03-19",{"name":222,"class":44},"Pfizer",30,{"id":225,"slug":226,"hasResults":12,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":230,"eligibilityCriteria":231,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":232,"targetDuration":4,"studyType":24,"phases":234,"briefSummary":235,"conditions":236,"keywords":237,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":248},"100604873","phase-2-a-study-to-evaluate-the-optimal-dose-adverse-events-and-change-in-disease-activity-of-intravenous-abbv-706-in-combination-with-atezolizumab-versus-standard-of-care-as-first-line-treatment-in-adult-participants-with-previously-untreated-extensive-stage-small-cell-lung-cancer-100604873","NCT07155174","A Study to Evaluate the Optimal Dose, Adverse Events and Change in Disease Activity of Intravenous ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Adult Participants With Previously Untreated Extensive Stage Small Cell Lung Cancer","A Phase 2 Randomized, Open Label, Multicenter Study to Evaluate the Optimal Dose, Safety, and Efficacy of ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Subjects With Previously Untreated Extensive Stage Small Cell Lung Cancer (ES-SCLC)","SEZanne","Inclusion Criteria:\n\n* Diagnosis of histologically or cytologically confirmed extensive stage small cell lung cancer (ES-SCLC) requiring treatment with first line therapy.\n* Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 during the screening period prior to the first dose of study treatment.\n* Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).\n* Suspected brain metastases at screening should have a computed tomography (CT)\u002F magnetic resonance imaging (MRI) of the brain prior to study entry.\n\nExclusion Criteria:\n\n* Have received any kind of treatment for limited stage small cell lung cancer (LS-SCLC).\n* Known active\u002Fsymptomatic central nervous system (CNS) metastases should be excluded.\n* History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD\u002Fpneumonitis on screening chest computed tomography (CT) scan should be excluded.\n* Have any clinically significant conditions that would adversely affect the participant's participation in the study, and the subject should have a life expectancy of at least 3 months.",{"count":233,"type":23},180,[155],"Small cell lung cancer (SCLC) is characterized by aggressive and rapid growth and a tendency to develop early spread to distant sites including mediastinal lymph nodes, liver, bones, adrenal glands, and brain. The purpose of this study is to assess safety, dose, change in disease activity of ABBV-706 given with atezolizumab, compared to standard of care (SOC) treatment (etoposide, carboplatin, atezolizumab, and optional lurbinectedin).\n\nABBV-706 is an investigational drug being developed for the treatment of SCLC. There are multiple treatment arms in this study. Participants will either receive ABBV-706 given with atezolizumab, at 1 of 2 doses, or SOC. Approximately 180 adult participants will be enrolled in the study across sites worldwide.\n\nIn the safety lead-in, participants with SCLC will receive intravenous (IV) ABBV-706 in 1 of 2 doses with IV atezolizumab, or IV SOC. In the expansion portion of the study, participants with SCLC will receive IV ABBV-706 in 1 of 2 doses with atezolizumab, or IV SOC, until the optimal dose of ABBV-706 is determined. The estimated duration of the study is up to 69.5 months.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.",[29],[29,63,132,238,239,240,134],"Etoposide","Carboplatin","Atezolizumab","2026-08-13",{"date":215,"type":37},{"date":244,"type":37},"2025-11-25",{"date":246,"type":23},"2031-09",{"name":143,"class":44},63,{"id":250,"slug":251,"hasResults":12,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":255,"eligibilityCriteria":256,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":24,"phases":258,"briefSummary":259,"conditions":260,"keywords":261,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":263,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":223},"100523424","phase-2-a-study-of-alisertib-in-patients-with-extensive-stage-small-cell-lung-cancer-100523424","NCT06095505","A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer","A Phase 2 Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer","ALISCA-Lung1","Inclusion Criteria:\n\n* Aged ≥18 years at signing of informed consent\n* Pathologically confirmed SCLC\n* Prior treatment with one platinum-based chemotherapy and an anti-PD-L1\u002FPD-1 immunotherapy. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to two prior treatment regimens\n\nExclusion Criteria:\n\n* Prior treatment with an AURKA specific-targeted or pan-Aurora-targeted agent, including alisertib in any setting\n\nNote: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.",{"count":5,"type":23},[155],"PUMA-ALI-4201 is a Phase 2 study evaluating alisertib monotherapy in patients with pathologically-confirmed small cell lung cancer (SCLC) following progression on or after treatment with one platinum-based chemotherapy and anti-PD-L1\u002FPD-1 immunotherapy agent. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to two prior treatment regimens. This study is intended to identify the biomarker-defined subgroup(s) that may benefit most from alisertib treatment and to evaluate the efficacy, safety, and pharmacokinetics of alisertib.",[29],[262,63],"Alisertib",{"date":217,"type":37},{"date":265,"type":37},"2024-02-08",{"date":267,"type":23},"2028-04-30",{"name":269,"class":44},"Puma Biotechnology, Inc.",{"id":271,"slug":272,"hasResults":12,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":276,"eligibilityCriteria":277,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":278,"targetDuration":4,"studyType":24,"phases":280,"briefSummary":281,"conditions":282,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":291},"100609712","phase-3-a-study-of-zl-1310-versus-investigators-choice-of-therapy-in-participants-with-relapsed-small-cell-lung-cancer-dllevate-100609712","NCT07218146","A Study of ZL-1310 Versus Investigator's Choice of Therapy in Participants With Relapsed Small Cell Lung Cancer (DLLEVATE)","A Randomized, Open-Label, Phase 3 Study of ZL-1310, a DLL3 Antibody-Drug Conjugate (ADC), Compared to Investigator's Choice Therapy in Participants With Relapsed Small Cell Lung Cancer","DLLEVATE","Inclusion Criteria:\n\n* Age \\>\u002F= 18 years, or considered an adult by local regulations, at the time of consent\n* Signed informed consent\n* Histologically or cytologically confirmed SCLC. Received 1L platinum-based systemic therapy and had documented disease progression during or after the most recent systemic therapy. Or received 2L tarlatamab is allowed.\n* Measurable disease according to RECIST v1.1 as assessed by the investigator.\n* Participants with a history of treated and stable or untreated and asymptomatic CNS metastases based on criteria per protocol.\n* Adequate organ and marrow function\n* Eastern Cooperative Group (ECOG) performance status of 0 or 1\n* Life expectancy of at least 3 months\n* Participants must be willing to undergo a tumor biopsy or provide archived tumor tissue sample at Screening\n* Participants must be willing and able to comply with protocol for the duration of the study\n\nExclusion Criteria:\n\n* Received more than one line of systemic therapy for Extensive-Stage SCLC.\n* Received any prior ADC with topoisomerase 1 inhibitor payload\n* Participants with another known malignancy with exceptions defined in the protocol.\n* History or suspected ILD\u002Fpneumonitis based on criteria per protocol\n* Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses.\n* Receipt of anti-cancer treatment known to treat cancers within 3 weeks before the first dose of study treatment.\n* Prior radiotherapy before study treatment based on criteria per protocol\n* Unresolved toxicity of Grade \\>\u002F= 2 from previous anti-cancer treatment, except for alopecia and skin pigmentation.\n* Known infection or active infection defined in the protocol.\n* Clinically significant active cardiovascular disease or history of arterial thromboembolic event within 6 months prior to the first dose of study treatment based on criteria per protocol.",{"count":279,"type":23},480,[26],"The purpose of this study is to evaluate the efficacy and safety of ZL-1310 compared to Investigator's Choice Therapy in participants with relapsed Small Cell Lung Cancer.",[96],"2026-08-12",{"date":217,"type":37},{"date":286,"type":37},"2025-11-30",{"date":288,"type":23},"2028-11-30",{"name":290,"class":44},"Zai Lab (Shanghai) Co., Ltd.",111,{"id":293,"slug":294,"hasResults":12,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":299,"targetDuration":4,"studyType":24,"phases":301,"briefSummary":302,"conditions":303,"keywords":305,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":318},"100377838","phase-1-petct-imaging-of-small-cell-lung-cancer-using-89zr-dfo-sc1656-100377838","NCT04199741","PET\u002FCT Imaging of Small Cell Lung Cancer Using 89Zr-DFO-SC16.56","Immuno-PET Imaging of Neuroendocrine Tumors Using 89Zr-DFO-SC16.56, a DLL3-targeting Monoclonal Antibody","Inclusion Criteria:\n\nSubject Inclusion Criteria for Adult population\n\n* Signed, informed consent\n* Age 18 or more years\n* Histologically confirmed, SCLC, (newly diagnosed or recurrent); small cell carcinoma of unknown or non-lung origin; or other types of neuroendocrine tumor OR Histologically confirmed prostate cancer, with suspected or confirmed NEPC based upon clinical assays obtained prior to the trial OR Histologically confirmed or suspected primary brain neoplasm OR Desmoplastic small round cell tumors, osteosarcoma, Ewing's sarcoma, rabdomyosarcoma, Wilms tumors, hepatoblastomas, rhabdoid tumors and neuroblastoma patients\n* At least one tumor lesion on CT2 or MRI ≥ 0.8 cm OR\n* Tumor detectable FDG PET, PSMA PET, DOTATATE PET, MIBG SPECT (or planar MIBG scan if SPECT unavailable) OR\n* MRI or bone scan that shows new osseous metastases. The scans should have been obtained in the last 12 weeks\n* ECOG performance status 0 to 2\n* Negative serum pregnancy test within 2 weeks of 89Zr-DFO-SC16.56 for women of child-bearing potential\n* Available archival tumor specimen suitable for DLL3 IHC or clinician already has plans to obtain tumor specimen as part of standard of care (unrelated to patient participation in 19-292) which will yield sufficient tumor specimen to allow for DLL3 IHC\n* For the prostate cancer patient cohort, as an alternative if archival tissue is not available, patients must be willing to undergo PET\u002FCT guided biopsy3 as described in section 9.3.\n\n  1. Patients with SCLC will be the primary study population, however patients with other types of neuroendocrine tumors may be included at the PI's discretion.\n  2. Criterion is intended to demonstrate presence of imageable disease. A low-dose CT (e.g. from a PET\u002FCT scan) may be used at PI's discretion.\n  3. While willingness to undergo the biopsy is required if archival tissue is not available, PET\u002FCT guided biopsy is not a mandatory study assessment. As described in section 9.3, the guided biopsy may be waived at the discretion of the principal investigator if the DLL3 PET\u002FCT reveals no sites of DLL3 tracer-avid tumor or if the principal investigator deems itis not in the best interest of the patient, according to best clinical judgement. The pediatric population would not be approached for an optional PET\u002FCT-guided biopsy\n\nSubject Inclusion Criteria for Pediatric population\n\n* Signed, informed consent\n* Age 4 or more years\n* High risk neuroblastoma patients\n* At least one tumor lesion on CT2 or MRI ≥ 0.8 cm OR Tumor detectable FDG PET, PSMA PET, DOTATATE PET, MIBG SPECT (or planar MIBG scan if SPECT unavailable) OR MRI or bone scan that shows new osseous metastases. The scans should have been obtained in the last 12 weeks\n* ECOG performance status 0 to 2\n* Performance Status: Subjects must have a Lansky (\\\u003C16 years) of at least 40\n* Negative serum pregnancy test within 2 weeks of 89Zr-DFO-SC16.56 for women of child-bearing potential\n\nExclusion Criteria:\n\nSubject Exclusion Criteria for the Adult population\n\n* History of anaphylactic reaction to humanized or human antibodies\n* Pregnant or breast feeding\n* Psychiatric illness that would interfere with compliance with the study procedures\n* Inability to undergo PET scan due to weight limit\n* Patients who require anesthesia or monitored sedation to tolerate PET scan procedure\n\nSubject Exclusion Criteria for the Pediatric population\n\n* History of anaphylactic reaction to humanized or human antibodies\n* Pregnant or breast feeding\n* Psychiatric illness that would interfere with compliance with the study procedures\n* Inability to undergo PET scan due to weight limit\n* Patients who require anesthesia or monitored sedation to tolerate PET scan procedure",{"count":300,"type":23},105,[57,155],"The purpose of this study is to look at how safe 89Zr-DFO-SC16.56 is, and how it is processed by the body in people with small cell lung cancer.",[29,304],"Small Cell Lung Carcinoma",[306,304,307,308,309],"Small cell lung cancer","89Zr-DFO-SC16.56","19-292","Memorial Sloan Kettering Cancer Center","2026-08-11",{"date":283,"type":37},{"date":313,"type":37},"2019-12-11",{"date":315,"type":23},"2027-06-11",{"name":309,"class":317},"OTHER",1,{"id":320,"slug":321,"hasResults":12,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":326,"targetDuration":4,"studyType":24,"phases":328,"briefSummary":329,"conditions":330,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":355},"100534718","phase-1-a-study-of-mgc026-in-participants-with-advanced-solid-tumors-100534718","NCT06242470","A Study of MGC026 in Participants With Advanced Solid Tumors","A Phase 1\u002F1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Adults ≥ 18 years old, able to provide informed consent\n* Adequate performance and laboratory parameters\n* Availability of archival or formalin-fixed paraffin-embedded tumor tissue sample. Participants may undergo a fresh tumor biopsy to obtain a specimen for testing if an archival tumor sample is not available. Participants with no available archival tissue sample who cannot safely undergo a fresh biopsy as determined by consultation between the sponsor and investigator are eligible\n* Unresectable, locally advanced or metastatic solid tumors including: squamous cell cancer (SCC) of the head and neck, esophageal SCC, squamous and non-squamous non-small cell lung cancer, small cell lung cancer, bladder cancer, sarcoma, endometrial cancer, melanoma, castration resistant prostate cancer, breast cancer, ovarian cancer, cervical cancer, colorectal cancer gastric or gastroesophageal cancer, pancreatic carcinoma, clear cell renal cell cancer or hepatocellular cancer.\n* Measurable disease per RECIST v1.1. Participants with metastatic CRPC without measurable disease are eligible.\n* Must be willing to use highly effective methods of birth control from the time of consent through 7 months after discontinuation of MGC026.\n* Not pregnant or breastfeeding.\n\nExclusion Criteria:\n\n* Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.\n* Another cancer that required treatment within the past 2 years, with the exception of those with low risk of cancer spreading or death such as adequately treated non melanomatous skin cancer, localized prostate cancer (Gleason Score \\\u003C 6), or carcinoma in situ.\n* Patients with history of prior central nervous system (CNS) metastasis must have been treated, be asymptomatic, and not have concurrent treatment for CNS disease, progression of CNS metastases on magnetic resonance imaging, computed tomography or positron emission tomography, or history of leptomeningeal disease or cord compression at the time of enrollment.\n* Treatment with surgery, systemic cancer therapy, immunotherapy, chimeric antigen receptor-T therapy, or anti-hormonal within protocol specified intervals.\n* Prior treatment with any B7-H3 targeted agent for cancer or any ADC with a topoisomerase payload.\n* Prior autologous or allogeneic stem cell or solid organ transplant.\n* Clinically significant cardiovascular, pulmonary, or gastrointestinal disorders.\n* Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 1 week of first study drug administration.\n* Known history of hepatitis B or C infection or known positive test for hepatitis B surface antigen or core antigen, or hepatitis C polymerase chain reaction.\n* Known positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome.\n* History of primary immunodeficiency.\n* Major trauma or major surgery within 4 weeks of first study drug administration.\n* Known hypersensitivity to recombinant proteins.",{"count":327,"type":23},250,[57],"The study is designed to understand the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of MGC026 in participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors The study has a dose escalation portion and a cohort expansion portion of the study.\n\nParticipants will receive MGC026 by intravenous (IV) infusion. The dose of MGC026 will be assigned at the time of enrollment. Participants may receive up to 35 treatments if there are no severe side effects and as long as the cancer does not get worse. Participants will be monitored for side effects, and progression of cancer, have blood samples collected for routing laboratory work, and blood samples collected for research purposes.",[331,332,333,334,335,96,336,337,94,338,339,95,91,340,341,342,343,90,344,345,109,346],"Advanced Solid Tumor","Advanced Cancer","Metastatic Cancer","Squamous Cell Carcinoma of Head and Neck","Non Small Cell Lung Cancer","Bladder Cancer","Sarcoma","Melanoma","Castration Resistant Prostatic Cancer","Gastric Cancer","Gastro-esophageal Cancer","Pancreas Cancer","Clear Cell Renal Cell Carcinoma","Platinum-resistant Ovarian Cancer","Breast Cancer","Esophageal Squamous Cell Cancer (SCC)","2026-08-10",{"date":310,"type":37},{"date":350,"type":37},"2024-03-06",{"date":352,"type":23},"2028-10",{"name":354,"class":44},"MacroGenics",12,{"id":357,"slug":358,"hasResults":12,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":363,"enrollmentInfo":364,"targetDuration":4,"studyType":24,"phases":366,"briefSummary":368,"conditions":369,"keywords":370,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":374,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":318},"100481733","phase-ii-trial-of-consolidative-thoracic-radiotherapy-for-es-sclc-after-standard-care-of-chemo-immunotherapy-100481733","NCT05552846","Phase II Trial of Consolidative Thoracic Radiotherapy for ES-SCLC After Standard Care of Chemo-immunotherapy","Consolidative Thoracic Radiotherapy for Extensive-stage Small-cell Lung Cancer Treated With Chemo-immunotherapy Followed by PD-1\u002FPD-L1 Maintenance Therapy：an Open Label, Single Arm Prospective Trial","Inclusion Criteria:\n\n1. Age between18 years and 80 years at time of study entry\n2. ECOG performance status of 0 or 1\n3. Body weight \\>30 kg\n4. Adequate bone marrow, liver and kidney function\n5. Life expectancy of at least 3 months\n6. At least one measurable (RECIST 1.1), thoracic lesion that can be irradiated with 45 Gy\u002F15 fractions\n7. Histologic or cytologic confirmation of small cell lung cancer\n8. Stage III-IV disease (TNM v8)\n9. Adequate pulmonary function with FEV1 \\>1 L or \\>30 % of predicted value and DLCO \\>30 % of predicted value\n10. Patients with brain metastases are eligible provided they are asymptomatic or treated and stable on steroids and\u002For anticonvulsants prior to the start of treatment -\n\nExclusion Criteria:\n\n1. Previous chemo-, immuno- or radiotherapy for SCLC\n2. Major surgical procedure last 28 days\n3. History of allogenic organ transplantation, autoimmune disease, immunodeficiency, hepatitis or HIV\n4. Uncontrolled intercurrent illness\n5. Other active malignancy\n6. Leptomeningeal carcinomatosis\n7. Immunosuppressive medication\n8. Pregnant or breastfeeding women","80 Years",{"count":365,"type":23},104,[367],"NA","This is an open-label, single arm Phase II study designed to evaluate the efficacy and safety of thoracic radiotherapy for extensive-stage small-cell lung cancer treated with PD-1\u002FPD-L1 plus etoposide platinum followed by PD-1\u002FPD-L1 maintenance therapy",[96],[371,372,373],"thoradic radiotherapy","immune checkpoint inhibitors","chemo-immunotherapy",{"date":283,"type":37},{"date":376,"type":37},"2021-01-30",{"date":378,"type":23},"2027-09-30",{"name":380,"class":317},"Ruijin Hospital",{"id":382,"slug":383,"hasResults":12,"nctId":384,"briefTitle":385,"officialTitle":385,"acronym":4,"eligibilityCriteria":386,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":387,"targetDuration":4,"studyType":24,"phases":389,"briefSummary":390,"conditions":391,"keywords":392,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":396,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":318},"100604875","phase-1-small-cell-lung-cancer-irinotecan-and-cdc2-like-kinase-inhibition-trial-slick-trial-100604875","NCT07155200","Small Cell Lung Cancer Irinotecan and CDC2-like Kinase Inhibition Trial (SLICK Trial)","Inclusion Criteria:\n\n* Histologically or cytologically confirmed small cell lung cancer that has progressed on at least one line of prior platinum-based chemotherapy, given with or without anti-PD-(L)1 therapy.\n* Presence of measurable disease per RECIST 1.1 criteria\n* At least 18 years of age.\n* ECOG performance status ≤ 2\n* Adequate bone marrow and organ function as defined below:\n\n  * Absolute neutrophil count ≥ 1.0 K\u002Fcumm\n  * Platelets ≥ 100 K\u002Fcumm\n  * Total bilirubin ≤ 1.5 x IULN (except participants with Gilbert's syndrome, who must have total bilirubin \\\u003C 3.0 mg\u002FdL)\n  * AST(SGOT)\u002FALT(SGPT) ≤ 2.5 x IULN (≤ 5 x IULN for patients with liver metastases)\n  * Calculated creatinine clearance \\> 35 mL\u002Fmin by Cockcroft-Gault\n* The effects of cirtuvivint on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 31 weeks after completion of study treatment (either drug). Should a woman become pregnant or suspect she is pregnant while participating in this study or should a man suspect he has fathered a child, s\u002Fhe must inform the treating physician immediately.\n* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria:\n\n* Prior or concurrent malignancy whose treatment or natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition (following discussion with the PI) are eligible for this trial.\n* Previous intolerance to irinotecan. Treatment with prior irinotecan is allowed as along as treatment was not discontinued for treatment related adverse events.\n* Currently receiving any other investigational agents.\n* Patients with untreated symptomatic brain metastases or with clinically evident CNS hemorrhage. Patients with treated brain metastases are allowed if post-treatment brain imaging after CNS-directed therapy shows no evidence of progression. Patients with asymptomatic, punctate brain metastases \\\u003C 5 mm are allowed.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to cirtuvivint, irinotecan, or other agents used in the study.\n* Concurrent diarrheal illness (such as inflammatory bowel disease) that requires medical therapy.\n* Undergone major surgery within 28 days prior to Cycle 1 Day 1\n* Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis at a level of Child-Pugh B or worse, cirrhosis (any degree) with a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis (defined as ascites from cirrhosis requiring diuretics or paracentesis), fatty liver, and inherited liver disease.\n* Unresolved grade 2 or higher toxicities from previous treatment with the exception of fatigue, lymphopenia, anemia, endocrine AEs that are being managed with hormone replacement, alopecia, or dysgeusia.\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to C1D1.\n* HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing is not required in the absence of known history of infection.\n* Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing is not required in the absence of known history of infection.\n* History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing is not required in the absence of known history of infection.\n* Known retinal abnormalities, including diabetic retinopathy, macular degeneration, other retinal degenerative diseases, or other retinal findings that may place the patient at risk.\n* Patients currently using or anticipating the need for food or drugs known to strongly inhibit or induce CYP3A4, such as ketoconazole, itraconazole, erythromycin, or rifampin, within 10 days prior to first dose of study medication.\n* Patients with a corrected QT interval (QTc) using Fridericia's formula (QTcF) \\> CTCAE v5.0 Grade 1 (\\>480 msec) based on the mean of triplicate evaluation at Screening. In patients with ventricular paced rhythm, a 50 msec subtraction should be applied to the QTc to calculate the QTcF, potential exceptions for patients with pacemakers should be discussed with the PI.",{"count":388,"type":23},42,[57,155],"Although small cell lung cancer (SCLC) responds dramatically to initial platinum-based chemotherapy, recurrences are nearly universal. The addition of atezolizumab, an immune checkpoint inhibitor, to front-line chemotherapy has recently demonstrated an improvement in overall survival (OS) in extensive stage SCLC (ES-SCLC). Subsequent lines of therapies are associated with modest efficacy in patients with relapsed disease, and the median overall survival is still 12 to 13 months at best.\n\nCirtuvivint is a small molecule inhibitor of the CDC2-like kinases (CLKs) and dual-specificity tyrosine-regulated kinases (DYRKs); inhibiting CLKs and DYRKs has been shown in preclinical models to cause tumor growth inhibition and sensitize cancer cells to cytotoxic chemotherapy.\n\nThis study is testing the hypothesis that adding cirtuvivint to chemotherapy in patients with relapsed SCLC will be well tolerated and improve the response rate and progression-free survival (PFS).",[96,304,29],[29,393,394],"CLK Inhibitors","Cirtuvivint","2026-08-09",{"date":283,"type":37},{"date":398,"type":37},"2025-12-18",{"date":400,"type":23},"2029-01-31",{"name":402,"class":317},"Washington University School of Medicine",{"id":404,"slug":405,"hasResults":12,"nctId":406,"briefTitle":407,"officialTitle":408,"acronym":4,"eligibilityCriteria":409,"healthyVolunteers":12,"sex":18,"minAge":410,"maxAge":4,"enrollmentInfo":411,"targetDuration":4,"studyType":24,"phases":413,"briefSummary":414,"conditions":415,"keywords":433,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":463,"startDateStruct":464,"completionDateStruct":466,"leadSponsor":468,"locationsCount":470},"100407463","the-evaluation-of-pc14586-in-patients-with-advanced-solid-tumors-harboring-a-tp53-y220c-mutation-pynnacle-100407463","NCT04585750","The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","A Phase 1\u002F2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","Inclusion Criteria:\n\n* At least 18 years of age or 12 to 17 years of age after Safety Review Committee approval.\n* Locally advanced or metastatic solid malignancy with a TP53 Y220C mutation\n* Eastern Cooperative Oncology Group (ECOG) status of 0 or 1\n* Previously treated with one or more lines of anticancer therapy and progressive disease\n* Adequate organ function\n* Measurable disease per RECIST v1.1 (Phase 2)\n\nAdditional Criteria for Inclusion in Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Anti-PD-1\u002FPD-L1 naive or must have progressed on treatment\n* Measurable disease\n\nExclusion Criteria:\n\n* Anti-cancer therapy within 21 days (or 5 half-lives) of receiving the study drug\n* Radiotherapy within 14 days of receiving the study drug\n* Primary CNS tumor\n* History of leptomeningeal disease or spinal cord compression\n* Brain metastases, unless neurologically stable and do not require steroids to treat associated neurological symptoms\n* Stroke or transient ischemic attack within 6 months prior to screening\n* Heart conditions such as unstable angina within 6 months prior to screening, uncontrolled hypertension, a heart attack within 6 months prior to screening, congestive heart failure, prolongation of QT interval, or other rhythm abnormalities\n* Strong CYP3A4 inducers and strong CYP2C9 inhibitors\u002Finducers within 14 days of first dose of rezatapopt\n* History of gastrointestinal (GI) disease that may interfere with absorption of study drug or patients unable to take oral medication\n* History of prior organ transplant\n* Known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer\n* Known, active uncontrolled Hepatitis B, Hepatitis C, or human immunodeficiency virus infection\n\nAdditional Criteria for Exclusion from Phase 2 (rezatapopt monotherapy)\n\n* Known KRAS mutation, defined as a single nucleotide variant (SNV) (Phase 2)\n\nAdditional Criteria for Exclusion from Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and discontinued from that treatment due to a Grade 3 or higher immune-related AE (irAE)\n* Received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention\n* Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy within 7 days prior to the first dose of study drug\n* Hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients\n* Active autoimmune disease that has required systemic treatment in past 2 years\n* History of radiation pneumonitis\n* History of (non-infectious) or active pneumonitis \u002F interstitial lung disease that required steroids\n* Active infection requiring systemic therapy\n* Known history of HIV infection\n* Has previously received rezatapopt","12 Years",{"count":412,"type":23},300,[57,155],"The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion of the study will assess the safety, tolerability and preliminary efficacy of multiple dose levels of rezatapopt as monotherapy and in Phase 1b in combination with pembrolizumab.",[331,416,333,417,418,109,94,419,91,345,420,421,422,423,29,209,304,103,424,63,425,97,108,426,427,428,429,430,431,432],"Advanced Malignant Neoplasm","Metastatic Solid Tumor","Lung Cancer","Prostate Cancer","Other Cancer","Locally Advanced","Head and Neck Cancer","Gall Bladder Cancer","NSCLC (Non-small Cell Lung Cancer)","Non-Small Cell Lung Carcinoma","HER2+ Breast Cancer","Non-Small Cell Lung Cancer","ER\u002FPR Positive Breast Cancer","HER2- Breast Cancer","HER2-positive Breast Cancer","HER2-negative Breast Cancer","ER\u002FPR(+), Her2(-) Breast Cancer",[434,435,436,437,438,439,440,441,442,443,444,445,446,447,448,449,450,451,452,453,454,455,456,457,458,459,460,461],"PC14586","p53","Y220C","Phase 1","Phase 1\u002F2","PMV","PMV Pharma","p53 mutation","TP53","TP53 mutation","p53 mutant","p53 reactivator","pembrolizumab","Keytruda","combination","PD-1","PD-L1","anti-PD-1","Merck","MSD","IgG4","mAb","Phase 1b","NGS","Next Generation Sequencing","precision","Phase 2","Rezatapopt","2026-08-07",{"date":347,"type":37},{"date":465,"type":37},"2020-10-29",{"date":467,"type":23},"2027-12-31",{"name":469,"class":44},"PMV Pharmaceuticals, Inc",77,{"id":472,"slug":473,"hasResults":12,"nctId":474,"briefTitle":475,"officialTitle":476,"acronym":477,"eligibilityCriteria":478,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":479,"targetDuration":4,"studyType":24,"phases":480,"briefSummary":481,"conditions":482,"keywords":483,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":492,"completionDateStruct":494,"leadSponsor":496,"locationsCount":318},"100651405","phase-2-nk-cells-plus-ici-for-sclc-maintenance-100651405","NCT07759856","NK Cells Plus ICI for SCLC Maintenance","A Randomized, Controlled, Open and Exploratory Clinical Trial of Immunization Combined With Allogeneic NK Cells in the Immune Maintenance Stage After First-line Treatment of Extensive Small Cell Lung Cancer","NK-ICI-SCLC","Inclusion Criteria:\n\n* 1: Male or female, aged 18 years or above\n\n  2: ECOG score 0-2\n\n  3: metastatic or extensive-stage small cell lung cancer (SCLC) confirmed by histology or cytology, followed by 4 cycles of platinum-based doublet-chemotherapy with at least 2 cycles of immune checkpoint inhibitor plus chemotherapy. And stable disease (SD), partial response (PR), or complete response (CR) as assessed by imaging (RECIST1.1 criteria) after the last treatment. (The checkpoint inhibitors used were those recommended by the NCCN, ESMO, and CSCO guidelines for extensivestage SCLC, including but not limited to: Duvalumab, atezolizumab, slulizumab, adbelimumab, toripalimab, etc.)\n\n  4: After standard concurrent chemoradiotherapy, LS-SCLC could be enrolled in this study if sensitive relapse (relapse more than 6 months after the end of first-line treatment) progressed to extensive-stage (Ed) and met the inclusion criteria No.3;\n\n  5: At least 4 weeks after major surgery or trauma, and the wound must be completely healed; At least 1 week after minor surgical procedures or trauma (e.g., tissue biopsy or fine-needle aspiration);\n\n  6: Objective measurable lesions according to RECIST 1.1 criteria;\n\n  7: predicted survival time ≥1 year;\n\n  8: bone marrow function: ANC≥1.5×109\u002FL, HB≥70 g\u002FL (blood transfusion allowed), PLT≥80×109\u002FL;\n\n  9: Liver function: ALT≤3×ULN, AST≤3×ULN, TBIL≤2×ULN (patients with liver metastasis ALT≤5×ULN, AST≤5×ULN, TBIL≤2×ULN) Child-Pugh score ≤7; Renal function: uric acid \\\u003C500 μmol\u002FL, serum creatinine \\\u003C1.7 mg\u002FdL, proteinuria ≤2+ or ≤2g\u002F24h, glomerular filtration rate (GFR) ≥60 ml\u002Fmin\u002F1.73m2;\n\n  10: no history of autoimmune diseases or current autoimmune diseases;\n\n  11: The subjects voluntarily participated in the study, signed the informed consent form, communicated well with the investigators, and completed the study in accordance with the protocol.\n\nExclusion Criteria:\n\n* 1:Participate in other clinical trials or use other research drugs or equipment within 4 weeks of the first treatment.\n\n  2: During the screening period and previous imaging evaluation, active or untreated CNS metastasis was found by CT scanning or MRI. Patients with asymptomatic CNS metastasis who had been treated in the past can participate in this study as long as they meet all the following criteria: corticosteroids are not needed to treat CNS diseases, and imaging examination has not found any progress from the end of CNS directional treatment to the screening period。 If new asymptomatic CNS metastases are found in patients during the screening period, they must undergo radiotherapy and\u002For CNS metastasis surgery\n\n  3: The effusion in the third space with clinical symptoms needs repeated drainage (for example, less than once every four weeks), such as pericardial effusion, pleural effusion and peritoneal effusion that are still uncontrollable after pumping or other treatments\n\n  4: Live vaccine was inoculated within 30 days before the first administration of the study drug. Live vaccines include but are not limited to measles, mumps, minute needle, chickenpox\u002Fherpes zoster, rabies, BCG, typhoid vaccine, etc. Seasonal influenza vaccine for injection is generally inactivated virus vaccine, which is allowed to be used.\n\n  5: The patient is known to have other malignant tumors, which are progressing or need active treatment in the past 3 years (except for in situ cancer or localized prostate cancer supplemented by PSA test)\n\n  6: Received major surgery, open surgical biopsy or severe traumatic injury 28 days before joining the group.\n\n  7: Clinically related or preexisting interstitial lung disease\n\n  8: Severe unhealed wound, ulcer or fracture\n\n  9: Suffering from autoimmune diseases requiring systemic treatment in the past 2 years\n\n  10: Unstable systemic concomitant diseases (active infection, moderate and severe chronic obstructive pulmonary disease, poorly controlled hypertension, unstable angina pectoris, congestive heart failure, myocardial infarction, cerebrovascular accident, pulmonary embolism or untreated history of Grade 3 deep vein thrombosis (DVT) within 6 months, serious mental disorder requiring drug control, liver, kidney or other metabolic diseases, neuropsychiatric diseases such as Alzheimer's disease).\n\n  11: According to the judgment of the researcher, there are patients with accompanying diseases that seriously endanger the safety of patients or affect the completion of the study.",{"count":388,"type":23},[155],"This research study is designed for patients with extensive-stage small cell lung cancer (ES-SCLC) who have already received four cycles of standard chemotherapy, with at least two cycles combined with immunotherapy, and have achieved disease control (stable disease, partial response, or complete response) at their last efficacy evaluation.\n\nIn this study, participants will be randomly assigned to one of two groups:\n\nGroup A will receive standard immunotherapy plus 1 to 3 courses of allogeneic natural killer (NK) cell therapy. Each course consists of six NK cell infusions given over 28 days.\n\nGroup B will receive standard immunotherapy alone. All participants will continue treatment until their disease progresses or they experience unacceptable side effects. The immunotherapy agents used in this study are those recommended by major international and national clinical guidelines for extensive-stage SCLC, including but not limited to durvalumab, atezolizumab, serplulimab, and adebrelimab.\n\nThe purpose of this study is to evaluate whether adding NK cell therapy to standard immunotherapy can provide additional benefits for patients with extensive-stage SCLC who have responded well to initial treatment.",[29],[484,485,486,487,488,489],"Extensive-Stage Small Cell Lung Cancer","Immunotherapy","Allogeneic NK Cells","Natural Killer Cells","Maintenance Therapy","Randomized Controlled Trial","2026-08-06",{"date":283,"type":37},{"date":493,"type":23},"2026-08",{"date":495,"type":23},"2029-08",{"name":497,"class":317},"Tianjin First Central Hospital",{"id":499,"slug":500,"hasResults":12,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":4,"eligibilityCriteria":504,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":505,"targetDuration":4,"studyType":507,"phases":4,"briefSummary":508,"conditions":509,"keywords":513,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":520,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":525,"locationsCount":318},"100220369","tissue-procurement-and-natural-history-study-of-people-with-non-small-cell-lung-cancer-small-cell-lung-cancer-extrapulmonary-small-cell-cancer-pulmonary-neuroendocrine-tumors-and-thymic-epithelial-tumors-100220369","NCT02146170","Tissue Procurement and Natural History Study of People With Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Extrapulmonary Small Cell Cancer, Pulmonary Neuroendocrine Tumors, and Thymic Epithelial Tumors","Tissue Procurement and Natural History Study of Patients With Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Extrapulmonary Small Cell Cancer, Pulmonary Neuroendocrine Tumors, and Thymic Epithelial Tumors","* INCLUSION CRITERIA:\n* Individuals with histologically or cytologically confirmed NSCLC, SCLC, ESCC, PNET, and TET.\n* Individuals consulted in the Clinical Center without a definitive diagnosis, but clinically considered likely to have a malignancy of the above histologies, pending further tissue acquisition and\u002For pathology review.\n* Age greater than or equal to18 years. Children are excluded from the study, as the above thoracic malignancies are rare in this population.\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Active symptomatic major organ disorder that would increase the risk of biopsy, including but not limited to ischemic heart disease, recent myocardial infarction, active congestive heart failure, pulmonary dysfunction.\n* Active concomitant medical or psychological illnesses that may increase the risk to the subject, at the discretion of the Principal Investigator.\n* Known HIV-positive individuals not on combination antiretroviral therapy are ineligible.",{"count":506,"type":23},2000,"OBSERVATIONAL","Background:\n\n\\- Lung cancer is the leading cause of cancer-related death worldwide. It causes more than one million deaths every year. Researchers want to gather tissue samples from people with lung and thymic cancers to understand the disease better. This may lead to new ways to diagnose and treat it.\n\nObjective:\n\n\\- To collect tissue samples for use in the study of lung cancers.\n\nEligibility:\n\n\\- Adults over age 18 with non-small cell lung cancer, small cell lung cancer, extra pulmonary small cell cancer, pulmonary neuroendocrine tumors, and thymic epithelial tumors.\n\nDesign:\n\n* Participants will be screened with a medical history, physical exam, and blood tests. They will be asked about how they perform their daily tasks.\n* Participants may be asked to give urine and blood samples. They may give a saliva sample if they cannot give blood. They will also give a sample of their tumor from a biopsy they had. They may also be given the option to undergo a biopsy.\n* Participants may have MRI, CT, and\u002For PET scans of the body. They will lie in a machine that takes pictures of the body.\n* After visits to the Clinical Center end, researchers will contact participants by phone every year to check on their health.",[427,29,510,511,512],"Extrapulmonary Small Cell Cancer","Pulmonary Neuroendocrine Tumors","Thymic Epithelial Tumors",[514,515,516,517,518,519],"Sample Acquisition","Genetic and Epigenetic Alterations","Mig6 Expression","Proteomic Analysis","Genomic Analysis","Natural History",{"date":462,"type":37},{"date":522,"type":37},"2014-05-28",{"date":524,"type":23},"2029-12-31",{"name":526,"class":527},"National Cancer Institute (NCI)","NIH",{"id":529,"slug":530,"hasResults":12,"nctId":531,"briefTitle":532,"officialTitle":533,"acronym":534,"eligibilityCriteria":535,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":536,"targetDuration":4,"studyType":24,"phases":538,"briefSummary":539,"conditions":540,"keywords":541,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":544,"lastUpdatePostDateStruct":545,"startDateStruct":546,"completionDateStruct":548,"leadSponsor":550,"locationsCount":552},"100531700","phase-3-a-study-of-ifinatamab-deruxtecan-versus-treatment-of-physicians-choice-in-subjects-with-relapsed-small-cell-lung-cancer-100531700","NCT06203210","A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer","A Phase 3, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice (TPC) in Subjects With Relapsed Small Cell Lung Cancer (SCLC) (IDeate-Lung02)","IDeate-Lung02","Inclusion Criteria\n\nParticipants must meet all the following criteria to be eligible for randomization into the study:\n\n1. Sign and date the informed consent form (ICF) prior to the start of any study-specific qualification procedures.\n2. Adults greater than or equal to (≥)18 years or the minimum legal adult age (whichever is greater) at the time the ICF is signed.\n3. Has histologically or cytologically documented extensive-stage small cell lung cancer (ES-SCLC).\n4. The participant must provide adequate baseline tumor samples with sufficient quantity and quality of tumor tissue content.\n5. Has received prior therapy with only one prior platinum-based line as systemic therapy for SCLC with at least 2 cycles of therapy and a chemotherapy free-interval \\[CTFI\\] (duration from stop date of the platinum agent in 1L therapy to radiological PD) of ≥30 days.\n6. Has at least 1 measurable lesion according to RECIST v1.1 as assessed by the investigator.\n7. Has documentation of radiological disease progression on or after the most recent systemic therapy.\n8. Has ECOG PS of less than or equal to (≤)1 within 7 days prior to Cycle 1 Day 1 (C1D1).\n9. Participants with brain metastasis\u002Fleptomeningeal disease are eligible if protocol specified criteria are met.\n\nExclusion Criteria\n\nParticipants who meet any of the following criteria will be disqualified from entering the study:\n\n1. Has received prior treatment with orlotamab, enoblituzumab, or other B7 homologue 3 (B7-H3) targeted agents, including I-DXd.\n2. Prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities.\n3. Has received any of the comparators used in this study or any topoisomerase I inhibitor.\n4. Has inadequate washout period before randomization as specified in the protocol.\n5. Has any of the following conditions within the past 6 months: cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event.\n6. Has uncontrolled or significant cardiovascular (CV) disease.\n7. Has clinically significant corneal disease.\n8. All of the following indicators of interstitial lung disease (ILD)\u002Fpneumonitis are excluded:\n\n   1. Any history of ILD\u002Fpneumonitis irrespective of steroid use, except for a history of radiation pneumonitis that did not require steroids.\n   2. Current diagnosis of ILD.\n   3. Clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out. Radiographic findings may include presence of lung parenchymal fibrosis, combined fibrosis and emphysema (CPFE), and\u002For interstitial lung abnormalities such as reticular opacities, traction bronchiectasis, honeycombing, or extensive ground glass opacities. Screening computed tomography (CT) scans must be submitted for independent central radiology review and results before randomization.\n9. Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, including, but not limited to, any underlying pulmonary disorder and potential pulmonary involvement caused by any autoimmune, connective tissue, or inflammatory disorders, prior pneumonectomy, or requirement for supplemental oxygen.",{"count":537,"type":23},540,[26],"This study is designed to compare the efficacy and safety of I-DXd with treatment of physician's choice in participants with relapsed small cell lung cancer (SCLC).",[29],[306,542,543],"Ifinatamab deruxtecan","I-DXd","2026-08-04",{"date":490,"type":37},{"date":547,"type":37},"2024-05-21",{"date":549,"type":23},"2029-12-01",{"name":551,"class":44},"Daiichi Sankyo",229,{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":4,"eligibilityCriteria":559,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":560,"targetDuration":4,"studyType":24,"phases":561,"briefSummary":562,"conditions":563,"keywords":567,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":570,"startDateStruct":571,"completionDateStruct":573,"leadSponsor":575,"locationsCount":4},"100650768","phase-1-a-study-of-lg00313112-in-participants-with-advanced-solid-malignancies-harboring-a-tp53-y220c-mutation-100650768","NCT07752875","A Study of LG00313112 in Participants With Advanced Solid Malignancies Harboring a TP53 Y220C Mutation","A Phase 1\u002F2, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of LG00313112 in Participants With Advanced Solid Malignancies Harboring a TP53 Y220C Mutation","Inclusion Criteria:\n\n1. Males and females aged 18 years or older\n2. Diagnosed locally advanced unresectable or metastatic solid tumor with a TP53 Y220C mutation.\n3. Documented disease progression during or after the most recent line of therapy. In addition, must be refractory to or intolerant of standard of care therapy or have no standard therapy.\n4. Measurable disease per RECIST v1.1.\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n6. Adequate organ function.\n\nExclusion Criteria:\n\n1. Investigational therapy or anti-cancer therapy within 21 days or 5 half-lives prior to the first dose of study drug.\n2. Radiotherapy within 14 days prior to the first dose of study drug.\n3. Known brain metastases (Exception: Brain metastases are permitted if the participant is neurologically stable), leptomeningeal disease or carcinomatous meningitis.\n4. Uncontrolled pleural effusion, pericardial effusion, or ascites.\n5. History of myocardial infarction or unstable angina within 6 months prior to enrollment, or clinically significant cardiac disease\n6. Serious infections requiring intravenous antibiotics within 14 days of first dose of study drug.\n7. Active uncontrolled Hepatitis B, Hepatitis C, or human immunodeficiency virus infection\n8. Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease\n9. History of prior organ transplant\n10. Currently receiving strong Cytochrome P4503A (CYP3A4) inhibitors or inducers",{"count":327,"type":23},[57,155],"This is a first-in-human, Phase 1\u002F2, open-label study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of LG00313112 in participants with advanced solid malignancies harboring a TP53 Y220C mutation",[109,29,335,91,564,345,94,422,565,566],"Esophageal Cancer","Pancreatic Cancer","Locally Advanced Unresectable or Metastatic Solid Tumor",[568],"Solid Tumor, TP53 Y220C Mutation","2026-08-03",{"date":462,"type":37},{"date":572,"type":23},"2026-12-01",{"date":574,"type":23},"2033-04-30",{"name":576,"class":44},"LG Chem",{"id":578,"slug":579,"hasResults":12,"nctId":580,"briefTitle":581,"officialTitle":582,"acronym":4,"eligibilityCriteria":583,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":584,"targetDuration":4,"studyType":24,"phases":586,"briefSummary":587,"conditions":588,"keywords":590,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":594,"startDateStruct":595,"completionDateStruct":596,"leadSponsor":598,"locationsCount":318},"100634920","phase-1-dsp-0390-in-combination-with-atezolizumab-for-small-cell-lung-cancer-100634920","NCT07545954","DSP-0390 in Combination With Atezolizumab for Small Cell Lung Cancer","A Pilot Study of DSP-0390 in Combination With Atezolizumab as Maintenance Therapy for Extensive Stage Small Cell Lung Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed small cell lung cancer.\n* Completed 3-4 cycles of induction chemoimmunotherapy as first line treatment of ES-SCLC without disease progression.\n* Measurable disease per RECIST 1.1.\n* At least 18 years of age.\n* ECOG performance status ≤ 2\n* Adequate bone marrow and organ function as defined below:\n\n  * Absolute neutrophil count ≥ 1.0 K\u002Fcumm\n  * Platelets ≥ 100 K\u002Fcumm\n  * Hemoglobin ≥ 8.0 g\u002FdL\n  * Total bilirubin ≤ 1.5 x IULN\n  * AST(SGOT)\u002FALT(SGPT) ≤ 3.0 x IULN (≤ 5.0 x IULN for patients with liver metastases)\n  * Calculated creatinine clearance \\> 40 mL\u002Fmin by Cockcroft-Gault\n* The effects of DSP-0390 on the developing human fetus are unknown. For this reason, people of childbearing potential and people able to father a child must agree to use adequate contraception prior to study entry, for the duration of study treatment, and for 6 months after the last dose of DSP-0390.\n* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria:\n\n* Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition (following discussion with the PI) are eligible for this trial\n* Currently receiving any other investigational agents, or received within 4 weeks prior to Day 1 (unless investigational immunotherapy, which may not have been received within 6 weeks prior to Day 1).\n* Patients with untreated symptomatic brain metastases or with clinically evident CNS hemorrhage. Patients with treated brain metastases are allowed if post-treatment brain-imaging after CNS-directed therapy shows no evidence of progression. Patients with asymptomatic, punctate brain metastases \\\u003C 5 mm are allowed.\n* Known contraindications to use of PD-L1 inhibitor as assessed by the treating physician.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to DSP-0390 or atezolizumab.\n* Undergone major surgery within 28 days prior to Cycle 1 Day 1.\n* Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. Patients with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Function Classification; to be eligible for this trial, patients should be a class 2B or better.\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to Cycle 1 Day 1.\n* Patient is known to have short-gut syndrome, or other condition that may significantly limit the ingestion or gastrointestinal absorption of drugs administered orally.\n* HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing not required in the absence of known history of infection.\n* Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing not required in the absence of known history of infection.\n* History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection.\n* Concurrent use of prohibited medications: carbamazepine, phenytoin, phenobarbital, other strong or moderate CYP3A4 inhibitor or inducer, or strong CYP2D6 inhibitors. These should be discontinued 1 week or 5 half-lives (whichever is greater) prior to study day 1. Note that both oral and IV ondansetron at doses ≤ 8 mg Q6h are permitted.\n* Patient has a clinically significant abnormal ECG, including those where QT prolongation is determined by the Fridericia formula (QTcF \\>450 msec for males and \\>470 msec for females); and\u002For the patient has a history of Torsade de Pointes.",{"count":585,"type":23},20,[57],"This is a single center pilot, phase Ib study with a safety lead-in evaluating the safety and preliminary efficacy of the EBP inhibitor DSP-0390 in combination with atezolizumab in patients with extensive stage small cell lung cancer (ES-SCLC) whose disease has not progressed after initial induction therapy with platinum-based chemotherapy and anti-PD-L1 immunotherapy (atezolizumab or durvalumab per treating physician's discretion). This trial is testing the hypothesis that inhibition of de novo cholesterol synthesis by DSP-0390 when used in combination with atezolizumab in the maintenance therapy of patients with ES-SCLC will be tolerable.",[96,589],"Small Cell Lung Cancer Extensive Stage",[591,592,485,593],"Small cell","Lipid metabolism","Maintenance",{"date":544,"type":37},{"date":569,"type":37},{"date":597,"type":23},"2030-02-28",{"name":402,"class":317},{"id":600,"slug":601,"hasResults":12,"nctId":602,"briefTitle":603,"officialTitle":604,"acronym":4,"eligibilityCriteria":605,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":606,"targetDuration":4,"studyType":507,"phases":4,"briefSummary":607,"conditions":608,"keywords":4,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":609,"startDateStruct":611,"completionDateStruct":613,"leadSponsor":615,"locationsCount":4},"100628977","sclc-tarlatamab-blood-collection-100628977","NCT07468656","SCLC Tarlatamab Blood Collection","Analysis of Blood Samples in Small Cell Lung Cancer Patients Treated With Tarlatamab","Inclusion Criteria:\n\n* Pathologically documented small cell lung cancer (SCLC) or neuroendocrine tumor\n* Appropriate candidate for treatment with tarlatamab based on investigator discretion\n* Age \\> 18 years\n* Signed written informed consent including HIPAA according to institutional guidelines\n\nExclusion Criteria:\n\n* Does not meet all inclusion criteria",{"count":7,"type":23},"The overall objective of this project is to prospectively collect blood samples throughout treatment with tarlatamab in patients with small cell lung cancer (SCLC). These samples will then be analyzed through a variety of assays to better characterize tarlatamab in the real-world setting.\n\nThe investigators will prospectively collect blood samples from 25 patients on days 1, 8, and 15 of tarlatamab treatment, as well as after each interval scan for disease monitoring. The investigators will also collect patient data including demographics and baseline characteristics, primary diagnosis, treatment history, and disease monitoring and progression.",[96],{"date":610,"type":37},"2026-08-05",{"date":612,"type":23},"2026-10",{"date":614,"type":23},"2028-12",{"name":616,"class":317},"Duke University",{"id":618,"slug":619,"hasResults":12,"nctId":620,"briefTitle":621,"officialTitle":622,"acronym":623,"eligibilityCriteria":624,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":625,"targetDuration":4,"studyType":24,"phases":627,"briefSummary":628,"conditions":629,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":631,"lastUpdatePostDateStruct":632,"startDateStruct":634,"completionDateStruct":635,"leadSponsor":637,"locationsCount":639},"100623877","phase-2-tarlatamab-for-sclc-brain-metastases-100623877","NCT07402343","Tarlatamab for SCLC Brain Metastases","A Single Arm Phase II Study Evaluating Intracranial Efficacy of Tarlatamab in Patients With Asymptomatic Active Brain Metastases From Small Cell Lung Cancer","T-BRAIN","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, a subject must meet all of the following criteria:\n\n1. Signed and written informed consent\n2. Age 18 years or older\n3. Patients with pathology proven metastatic SCLC\n4. Pretreated with at least platinum-doublet chemotherapy with or without immunotherapy, no maximum of previous lines of systemic therapy\n5. WHO\u002FECOG PS 0-1\n6. Estimated life expectancy 12 weeks or more\n7. At least one asymptomatic active (newly diagnosed or unequivocally progressive) untreated brain metastasis ≥ 5mm:\n\n   1. Subjects with largest measurable intracranial lesion ≥5 mm but \\\u003C10mm may be allowed to enroll upon agreement with investigator (for patients with target lesions of ≥ 5mm but \\\u003C10 mm, 1.5 mm slice thickness brain MRI is required).\n   2. \"Untreated\" refers to the lesion not being previously treated with stereotactic radiosurgery\u002Ftherapy (SRS\u002FSRT) or surgery.\n   3. Prior treatment with whole brain radiation therapy or local surgery is permissible provided unequivocal progression in the lesion has since occurred\n8. For at least 7 days prior to study start: Patient must be asymptomatic from CNS metastases and on a stable dose of anti-epileptics and corticosteroids. Maximum dose of steroids is 10 mg prednisolone or equivalent\u002Fday, dose should be noted.\n9. Adequate organ and bone marrow function, defined as:\n\n   a. Hematological function: i. Absolute neutrophil count ≥1.5 x109\u002FL ii. Platelet count ≥ 100 x109\u002FL iii. Hemoglobin ≥ 5.6 mmol\u002Fl b. Coagulation function: i. Protrombin time (PT)\u002F international normalized ratio (INR) and partial thromboplastin time (PTT) or activated partial thromboplastin time (APTT) ≤ 1.5 x institutional upper limit of normal (ULN) except for subjects receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to start of study treatment.\n\n   c. Renal function: i. Estimated glomerular filtration rate (eGFR) based on Modification of Dietin Renal Disease (MDRD) calculation \\> 30 mL\u002Fmin\u002F1.73 m2 d. Hepatic function: i. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 3x ULN (or \\\u003C 5x ULN for subjects with liver metastases) ii. Total bilirubin \\\u003C 1.5x ULN (or \\\u003C 2x ULN for subjects with liver metastases), except for subjects with Gilberts disease e. Pulmonary function: i. No clinically significant pleural effusion. Pleural effusions managed with indwelling pleural catheter (eg, PleurX) are allowed.\n\nii. Baseline oxygen saturation \\> 90% on room air f. Cardiac function: i. Cardiac ejection fraction ≥50%, no clinically significant pericardial effusion as determined by an echocardiogram (ECHO) or multigated acquisition (MUGA) scan, and no clinically significant electrocardiogram (ECG) finding\n\nExclusion Criteria:\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study:\n\n1. Symptomatic BM (if asymptomatic with corticosteroids with a maximum dose of steroids of 10 mg prednisolone or equivalent\u002Fday, the patient is eligible). If in doubt, discussion with the sponsor is necessary\n2. Leptomeningeal metastases (evaluated with MRI brain)\n3. BM in eloquent area (to be discussed with neuro-oncologist)\n4. Contra-indication for MRI\n5. Prior history of severe or life-threatening events from any immune-mediated therapy\n6. Grade 2 or higher toxicity from previous systemic therapy, except for alopecia\n7. History of other malignancy within the past 2 years, with the following exceptions:\n\n   1. Malignancy treated with curative intent before enrolment, with no known active disease and felt to be at low risk for recurrence by the treating physician, after discussion with the sponsor\n   2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n   3. adequately treated cervical cancer in situ without evidence of disease\n   4. adequately treated breast ductal carcinoma in situ without evidence of disease\n   5. prostatic intraepithelial neoplasia without evidence of prostate cancer\n   6. adequately treated urothelial papillary non-invasive carcinoma or carcinoma in situ\n8. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g. colitis or Crohn's disease\\], systemic lupus erythematosus, sarcoidosis, granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc), autoimmune pneumonitis, and autoimmune myocarditis. The following are exceptions to this criterion:\n\n   1. Subjects with vitiligo or alopecia\n   2. Subjects with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement\n   3. Any chronic skin condition that does not require systemic therapy\n   4. Subjects without active disease in the last 5 years may be included but only after consultation with the sponsor\n   5. Subjects with coeliac disease controlled by diet alone\n9. Myocardial infarction and\u002For symptomatic congestive heart failure (New York Heart Association \\> class II, appendix 2), within 6 months prior to first dose of study treatment\n10. History of arterial thrombosis (e.g. stroke or transient ischemic attack) within 6 months prior to first dose of study treatment\n11. Evidence of ILD or active, non-infectious pneumonitis\n12. History of solid organ transplant\n13. Major surgical procedures within 28 days prior to first dose of study treatment\n14. Presence of active HIV or hepatitis infection\n\n    1. HIV infection: subjects with HIV infection on antiviral therapy and undetectable viral load are permitted with a requirement for regular monitoring for reactivation for the duration of the treatment on study per local or institutional guidelines\n    2. Active hepatitis C infection (subjects with detectable hepatitis C antibody \\[HCV Ab\\] and hepatitis C virus (HCV) RNA viral load above the limit of quantification) are not allowed. Subjects with presence of HCV antibody (HCV Ab positive) and HCV RNA viral load below the limit of quantification (HCV RNA negative) with or without prior treatment are allowed\n    3. Active hepatitis B infection (subjects with presence of hepatitis B surface antigen \\[HBsAg-positive\\] and hepatitis B virus (HBV) DNA viral load above the limit of quantification \\[HBV DNA positive) are not allowed. Subjects with resolved HBV infection, defined as absence of HBV surface antigen (HBsAg-negative) and presence of HBV core antibody (anti-HBc positive) followed by an HBV DNA viral load below the limit of quantification (HBV DNA negative) are allowed with a requirement for regular monitoring for reactivation for the duration of treatment on the study and assessing the need for HBV prophylaxis therapy per local or institutional guidelines. Subjects with inactive HBV infection inactive carrier state, defined as presence of HBV surface antigen (HBsAg-positive) and HBV DNA viral load below the limit of quantification (HBV DNA negative) are allowed with the requirement for regular monitoring for reactivation for the duration of the treatment on the study and assessing the need for HBV prophylaxis therapy per local or institutional guidelines.\n15. Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 14 days prior to first dose of study treatment\n\n    a. Low-dose corticosteroids (prednisone ≤ 10 mg per day or equivalent is permitted during the study)\n16. Subjects with symptoms and\u002For clinical signs and\u002For radiographic signs that indicate an acute and\u002For uncontrolled active systemic infection within 7 days prior to the first dose of study treatment\n\n    a. Note: simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment. Subjects requiring oral antibiotics who have been afebrile \\> 24 hours, have no leukocytosis, nor clinical signs of an infection are eligible. Screening for chronic infectious conditions is not required unless otherwise noted as exclusion criteria.\n17. Treatment with live virus, including live-attenuated vaccination, within 4 weeks prior to the first dose of study treatment. Inactive vaccines (e.g. non-live or non-replication agent) and live viral non-replicating vaccines (e.g. Jynneos for mpox infection) within 3 days prior to first dose of study treatment\n18. Prior therapy with any selective inhibitor of the DLL3 pathway\n19. Receiving another anticancer therapy. Adjuvant hormonal therapy for resected breast cancer is permitted.\n20. Treatment in an alternative investigational trial within 28 days prior to enrollment\n21. Female subjects of childbearing potential unwilling to use protocol specified method of contraception (appendix 3) during treatment and for an additional 60 days after the last dose of tarlatamab\n22. Female subjects who are breastfeeding or who plan to breastfeed while on study through 60 days after the last dose of tarlatamab\n23. Female subjects planning to become pregnant or donate eggs while on study through 60 days after the last dose of tarlatamab\n24. Female subjects of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive serum pregnancy test\n25. Male subjects with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 60 days after the last dose of tarlatamab\n26. Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 60 days after the last dose of tarlatamab\n27. Male subjects unwilling to abstain from donating sperm during treatment and for an additional 60 days after the last dose of tarlatamab\n28. Subject has known sensitivity to any of the products or components to be administered during dosing of tarlatamab.\n29. History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.\n30. Subjects likely to not be available to complete all protocol-required study visits or procedures, and\u002For to comply with all required study procedures to the best of the subject and investigators knowledge.",{"count":626,"type":23},35,[155],"A single arm phase II study evaluating intracranial efficacy of tarlatamab in patients with asymptomatic active brain metastases from small cell lung cancer (SCLC).",[29,630],"Brain Metastases, Adult","2026-07-30",{"date":633,"type":37},"2026-07-31",{"date":493,"type":23},{"date":636,"type":23},"2030-02",{"name":638,"class":317},"Maastricht University Medical Center",4,{"id":641,"slug":642,"hasResults":12,"nctId":643,"briefTitle":644,"officialTitle":645,"acronym":4,"eligibilityCriteria":646,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":647,"targetDuration":4,"studyType":24,"phases":649,"briefSummary":650,"conditions":651,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":652,"lastUpdatePostDateStruct":653,"startDateStruct":655,"completionDateStruct":657,"leadSponsor":659,"locationsCount":118},"100587687","phase-1-study-of-nms-03305293-in-adult-patient-with-relapsed-small-cell-lung-cancer-100587687","NCT06931626","Study of NMS-03305293 in Adult Patient With Relapsed Small Cell Lung Cancer","Study of NMS-03305293, a Non-Trapping PARP1-Specific PARP Inhibitor in Relapsed Small Cell Lung Cancer","Inclusion Criteria -\n\n* Histologically confirmed extensive-stage Small Cell Lung Cancer (SCLC); must have failed prior front-line platinum-based therapy including immune therapy with relapse within 6 months followed by failed tarlatamab therapy, if available and appropriate, and no more than 3 total prior lines of systemic therapy (therapy terminated due to toxicity or drug shortage, in the absence of Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 progression, will be considered part of the same line). Sponsor may opt to allow history of treatment free interval from front-line longer than 6 months .\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n* Patient must have progressed radiographically on or after their most recent line of anticancer therapy and have measurable disease as defined by RECIST v1.1 (radiologically measured by the Investigator).\n* The interval from prior antitumor treatment should be at least 2 weeks or 5 half-lives, whichever longer for small-molecule agents and chemotherapies. For prior biologic therapy, including monoclonal antibodies, antibody-drug conjugates, immune checkpoint inhibitors, and bispecific antibodies, the interval should be at least 4 weeks or 5 half-lives, whichever is longer, unless otherwise justified based on the agent's known pharmacokinetics, pharmacodynamics, and residual toxicities.\n* All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 Grade ≤ 1 or to the baseline laboratory values as defined in the protocol.\n* Patients must use highly effective contraception or true abstinence.\n* Ability to swallow capsules intact (without chewing, crushing, or opening).\n\nExclusion Criteria -\n\n* Current enrollment in another interventional clinical trial.\n* Current treatment with other anticancer agents or devices.\n* Major surgery, other than surgery for recurrent SCLC, within 4 weeks prior to treatment start.\n* Patients with prior wide-field radiotherapy (RT) affecting at least 20 percent of the bone marrow.\n* Histologically transformed SCLC, i.e. tumors initially diagnosed as Non-Small Cell Lung Cancer (NSCLC) or mixed lung adenocarcinoma\n* Known paraneoplastic syndrome uncontrolled or that required therapeutic changes (either new\u002Facute or chronic) in the 14 days prior to study entry\n* Use of full-dose anticoagulants unless the International Normalized Ratio (INR) or a Partial Thromboplastin Time (PTT) is within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose of anticoagulants for at least 2 weeks before enrollment.\n* Treatment with concomitant medications known to be sensitive substrates of CYP2D6 and CYP2C19 that cannot be replaced with another treatment.\n* Treatment with systemic immune modulators such as corticosteroids at prednisone equivalent dose of \\> 10 mg\u002Fday, cyclosporine and tacrolimus or radiotherapy within 28 days before treatment start.\n* Breast-feeding women or women planning to breast feed during the study or within 3 months after study treatment.\n* Known hypersensitivity to any component of NMS-03305293 or Temozolomide (TMZ) drug formulations.\n* Known active, life-threatening or clinically significant uncontrolled systemic infection (bacterial, fungal, viral including Human Immunodeficiency Virus \\[HIV\\] positivity or Hepatitis B Virus \\[HBV\\] or Hepatitis B Virus \\[HCV\\] infections) requiring systemic treatment; HIV or Acquired Immune Deficiency Syndrome (AIDS)-related illness are allowed as long as controlled more than 6 months to undetectable on anti-HIV medications.\n* Patients with QT interval using Fridericia standard (QTcF) interval \\>450 milliseconds or with risk factors for torsade de pointes (e.g., uncontrolled heart failure, uncontrolled hypokalemia, history of prolonged QTc interval or family history of long QT syndrome). For patients receiving treatment with concomitant medications known to prolong the QTc interval, replacement with another treatment prior to enrollment is mandatory. If concomitant use of anti-emetics is considered essential for the care of the patients, follow instruction in this protocol\n* Known active gastrointestinal disease (e.g., documented gastrointestinal ulcer, Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes or structural issues or ulcer that would impact on drug absorption.\n* Any of the following in the previous 6 months: myocardial infarction, unstable angina, coronary\u002Fperipheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, active bleeding disorder and interstitial lung disease.\n* History of long QT disorder or familial sudden death syndromes or related syndromes in the opinion of the Investigator.\n* Currently active second malignancy, except for adequately treated basal or squamous cell skin cancer and\u002For cone biopsied or post curative intention in situ carcinoma of the cervix uteri and\u002For superficial bladder cancer.\n* Symptomatic, or untreated central nervous system (CNS) lesions except stable and well controlled with no neurological symptoms; patients receiving corticosteroids to control neurological symptoms should be on stable doses for at least 14 days before study entry.\n* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study or could compromise protocol objectives in the opinion of the Investigator and\u002For the Sponsor.\n\nNOTE: Other protocol defined inclusion and exclusion criteria may apply.",{"count":648,"type":23},10,[57],"This is an open-label study of NMS-03305293 with Temozolomide (TMZ) in patients with Small Cell Lung Cancer (SCLC). The aim of this study is to determine the safety and tolerability, as well as to evaluate the anti-tumor efficacy and pharmacokinetics of NMS-03305293 in combination with TMZ.",[29],"2026-07-23",{"date":654,"type":37},"2026-07-24",{"date":656,"type":37},"2025-08-15",{"date":658,"type":23},"2027-02-28",{"name":660,"class":44},"Nerviano Medical Sciences",{"id":662,"slug":663,"hasResults":12,"nctId":664,"briefTitle":665,"officialTitle":666,"acronym":667,"eligibilityCriteria":668,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":669,"enrollmentInfo":670,"targetDuration":4,"studyType":507,"phases":4,"briefSummary":672,"conditions":673,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":688,"lastUpdatePostDateStruct":689,"startDateStruct":691,"completionDateStruct":693,"leadSponsor":695,"locationsCount":697},"100602476","destiny-pantumour04-100602476","NCT07124000","DESTINY-PANTUMOUR04","Effectiveness of T-DXd Across HER2-positive Solid Tumors in Patients Who Have Received Prior Systemic Treatment and Have no Satisfactory Alternative Treatment Options: A Hybrid Observational Study","DP-04","Inclusion Criteria:\n\n1. Adults aged ≥18 years\n2. Patients with locally advanced, unresectable, or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options as determined by the Investigator (see Exclusion Criterion 1 for excluded solid tumors);\n3. A clinician decision has been made for treatment with T-DXd in accordance with the FDA label;\n4. HER2-positive (IHC 3+) by local testing prior to study enrolment at the time of signed and dated informed consent;\n5. Patients who are willing and able to provide a signed and dated informed consent.\n\nExclusion Criteria:\n\n1. Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, NSCLC, adenocarcinoma of the gastric body or gastroesophageal junction or hematological malignancies;\n2. Prior T-DXd therapy;\n3. Patients without a baseline assessment of tumor burden undertaken prior to initiating T-DXd.\n4. Patient is participating in a clinical trial at time of enrolment","130 Years",{"count":671,"type":23},100,"This study will evaluate the effectiveness of T-DXd in patients with HER2-positive (IHC 3+) locally advanced, unresectable, or metastatic solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options in a real-world setting in the US",[674,675,336,95,94,564,423,676,422,677,338,678,679,680,109,565,419,93,681,337,29,682,683,684,685,686,687],"Adenocarcinoma (NOS)","Anal Cancer","Gastrointestinal Stromal Tumour","Liver Cancer","Mouth Cancer","Nasopharangeal Cancer","Neuroendocrine, Gastrointestinal Cancer","Salivary Gland Cancer","Testicular Cancer","Throat Cancer","Thyroid Cancer","Urethral Cancer","Vaginal Cancer","Vulvar Cancer","2026-07-21",{"date":690,"type":37},"2026-07-22",{"date":692,"type":37},"2025-09-18",{"date":694,"type":23},"2028-03-30",{"name":696,"class":44},"AstraZeneca",18,{"id":699,"slug":700,"hasResults":12,"nctId":701,"briefTitle":702,"officialTitle":703,"acronym":4,"eligibilityCriteria":704,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":82,"enrollmentInfo":705,"targetDuration":4,"studyType":24,"phases":706,"briefSummary":707,"conditions":708,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":709,"lastUpdatePostDateStruct":710,"startDateStruct":711,"completionDateStruct":713,"leadSponsor":715,"locationsCount":648},"100612404","phase-2-a-phase-ii-clinical-study-to-evaluate-hlx43-in-combination-with-serplulimab-in-subjects-with-advanced-lung-cancer-100612404","NCT07253142","A Phase II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Subjects With Advanced Lung Cancer","A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Combination With Serplulimab (Humanized Anti-PD-1 Monoclonal Antibody Injection) in Advanced Stage Lung Cancer","Inclusion Criteria:\n\n* 1\\. Voluntarily to participate in the trial, and be able to complete the study as required by the protocol;\n* 2\\. Age ≥18 years and ≤75 years;\n* 3\\. Histologically or cytologically confirmed locally advanced (stage IIIB\u002FIIIC) or metastatic (stage IV) NSCLC unsuitable for radical treatment without actionable gene alteration (AGA); or Histologically or cytologically confirmed SCLC unsuitable for radical treatment, with evidence of disease progression or recurrence;\n* 4\\. Subjects must meet the following prior treatment requirements:\n\n  1. Have received platinum-based chemotherapy combined with anti-PD-1\u002FL1 monoclonal or bispecific antibodies as prior first-line treatment; have received no more than second-line treatment; or\n  2. Have received platinum-based chemotherapy and anti-PD-1\u002FL1 monoclonal or bispecific antibodies (in any sequence) as sequential treatment; have received no more than third-line treatment;\n* 5\\. Within 4 weeks prior to randomization, have at least one measurable lesion according to RECIST 1.1 efficacy evaluation criteria;\n* 6\\. Subjects agree to provide archived tumor tissue samples (from the most recent surgery or biopsy, preferably within 2 years) that meet testing requirements or agree to undergo a biopsy to collect tumor tissue for PD-L1 expression testing;\n* 7\\. Before the first administration of the investigational drug, there must be at least a 3-week interval or 5 half-lives of the drug (whichever is shorter) from prior major surgical procedures, device therapy, local radiotherapy (excluding palliative radiotherapy for bone lesions), cytotoxic chemotherapy, immunotherapy, or biological therapy. There must be at least a 2-week interval from prior hormone therapy or small molecule targeted therapy, and at least a 1-week interval from traditional Chinese medicine with anti-tumor indications or minor surgical procedures. Adverse events caused by prior treatment must have recovered to CTCAE v5.0 ≤ grade 1 (excluding grade 2 peripheral neurotoxicity and alopecia);\n* 8\\. ECOG performance status score of 0-1 within one week prior to randomization;\n* 9\\. Expected survival time of more than 3 months;\n* 10\\. Laboratory tests within one week prior to randomization confirm adequate organ function (within 14 days before the first administration, without receiving treatments such as transfusion, granulocyte colony-stimulating factor, thrombopoietin, or erythropoietin);\n* 11\\. Male and female subjects with reproductive potential must agree to use at least one highly effective contraceptive method during the trial and for at least 6 months after the last administration of the investigational drug. Female subjects of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.\n\nExclusion Criteria:\n\n* 1\\. Mixed SCLC, mixed NSCLC, or sarcomatoid carcinoma components confirmed by tumor histology or cytology;\n* 2\\. Imaging suggests tumor invasion of major blood vessels or important organs, or the presence of a risk of esophago-tracheal fistula or esophagopleural fistula;\n* 3\\. Previously received any drug therapy targeting topoisomerase I, including chemotherapy or ADC drugs;\n* 4\\. Received radical radiotherapy within 3 months prior to the first dose;\n* 5\\. History of any second malignancy within 2 years prior to randomization, except for early-stage malignancies treated with radical therapy (carcinoma in situ or stage I tumors), such as non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, ductal carcinoma in situ of the breast, or papillary thyroid carcinoma;\n* 6\\. History of adverse events leading to permanent discontinuation of immunotherapy, or a history of ≥ grade 2 immune-related pneumonitis or immune-related myocarditis;\n* 7\\. Presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;\n* 8\\. Presence of spinal cord compression or clinically active central nervous system metastases (referring to untreated or symptomatic metastases, or metastases requiring corticosteroids or anticonvulsants to control related symptoms), or meningitis carcinomatosa. Subjects who have previously received treatment for brain metastases (e.g., whole-brain radiotherapy or stereotactic brain radiotherapy) may participate in the study, provided they have been clinically stable for at least 4 weeks with no imaging evidence of brain metastasis progression;\n* 9\\. History or current presence of clinically severe lung impairment caused by pulmonary diseases, including but not limited to any underlying pulmonary disease (e.g., pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease, restrictive pulmonary disease, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, pleural effusion, etc., within 3 months prior to the first dose) or any autoimmune, connective tissue, or inflammatory diseases potentially involving the lungs (e.g., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or subjects who have undergone pneumonectomy, which may interfere with the detection and management of suspected drug-related pulmonary toxicity; subjects with radiation pneumonitis within 6 months;\n* 10\\. Subjects with poorly controlled cardiovascular or cerebrovascular clinical symptoms or diseases;\n* 11\\. Presence of active systemic infectious diseases requiring intravenous antibiotic therapy within 2 weeks prior to randomization;\n* 12\\. Use of moderate or strong CYP2D6 or CYP3A inhibitors or inducers within 2 weeks prior to randomization;\n* 13\\. Patients who received systemic corticosteroids (prednisone \\>10mg\u002Fday or equivalent doses of similar drugs) or other immunosuppressive therapy within 2 weeks prior to randomization;\n* 14\\. Presence of known active or suspected autoimmune diseases. However, patients with autoimmune-related hypothyroidism receiving thyroid hormone replacement therapy are allowed to participate in the study; patients with controlled type 1 diabetes receiving insulin therapy are allowed to participate in the study;\n* 15\\. Received live or attenuated live vaccines within 4 weeks prior to randomization;\n* 16\\. Known history of allergic reactions to macromolecular protein preparations\u002Fmonoclonal antibodies, or allergies to components of the investigational drug formulation;\n* 17\\. Active pulmonary tuberculosis;\n* 18\\. History of immunodeficiency diseases, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation;\n* 19\\. Active HBV or HCV infection or HBV\u002FHCV co-infection;\n* 20\\. Pregnant or lactating women;\n* 21\\. Subjects with a known history of psychiatric drug abuse, substance abuse, or alcoholism; patients who have ceased alcohol consumption may be enrolled;\n* 22\\. The investigator considers the subject unsuitable for participation in this clinical study due to any clinical or laboratory abnormalities or other reasons.",{"count":5,"type":23},[155],"The study is to explore the the reasonable dosage and to evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in combination with Serplulimab (anti-PD-1 humanized monoclonal antibody injection) in patients with advanced lung cancer.",[335,29],"2026-07-20",{"date":688,"type":37},{"date":712,"type":37},"2026-02-05",{"date":714,"type":23},"2028-06-19",{"name":716,"class":44},"Shanghai Henlius Biotech"]