[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"squamous-non-small-cell-lung-cancer-sqnsclc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:squamous-non-small-cell-lung-cancer-sqnsclc":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,54,79],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100650274","phase-4-metronomic-oral-paclitaxel-plus-pd-1-pd-l1-inhibitor-maintenance-in-advanced-lung-cancer-pulse-study-100650274",false,"NCT07744698","Metronomic Oral Paclitaxel Plus PD-1\u002F PD-L1 Inhibitor Maintenance in Advanced Lung Cancer (PULSE Study)","Efficacy and Safety of Metronomic Oral Paclitaxel Plus an Immune Checkpoint Inhibitor as Maintenance Therapy After First-Line Induction in Advanced Squamous Non-Small Cell Lung Cancer and Extensive-Stage Small Cell Lung Cancer: A Multicenter, Multi-Cohort Exploratory Study","PULSE","Inclusion Criteria:\n\n* 1\\. The participant has been fully informed about the study, voluntarily agrees to participate, provides written informed consent, and is willing to comply with long-term follow-up and study medication management.\n* 2\\. Age 18 to 75 years, inclusive.\n* 3\\. The participant meets the disease-specific requirements for either Cohort A or Cohort B: - Cohort A: Histologically and\u002For cytologically confirmed squamous non-small cell lung cancer(sqNSCLC), clinical stage IIIB to IV, unresectable and not suitable for definitive chemoradiotherapy, without actionable driver-gene alterations, and treatment-naive before initiation of first-line induction therapy. - Cohort B: Histologically and\u002For cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC), defined according to the eighth edition of the American Joint Committee on Cancer staging system as stage IV disease, including any T, any N, and M1a, M1b, or M1c disease, or T3 to T4 disease due to multiple pulmonary nodules or disease that is too extensive or bulky to be included within a tolerable definitive radiotherapy field.\n* 4\\. The participant has completed the required first-line induction regimen: - Cohort A: Completion of four cycles of a PD-1 or PD-L1 inhibitor plus cisplatin or carboplatin and paclitaxel or nab-paclitaxel, with a best induction response of complete response (CR), partial response (PR), or stable disease (SD) and no evidence of disease progression. - Cohort B: Completion of four cycles of a PD-1 or PD-L1 inhibitor plus cisplatin or carboplatin and etoposide, with a best induction response of CR, PR, or SD and no evidence of disease progression.\n* 5\\. The last dose of first-line induction treatment was administered no more than 28 days before the first study treatment.\n* 6\\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* 7\\. Estimated life expectancy of at least 3 months.\n* 8\\. Adequate bone marrow and organ function, including: - Absolute neutrophil count (ANC) of at least 1.5 × 10⁹\u002FL, platelet count of at least 100 × 10⁹\u002FL, and hemoglobin of at least 90 g\u002FL, without blood transfusion, growth-factor support, or erythropoietin within 14 days before assessment. - International normalized ratio (INR) and\u002For prothrombin time (PT) no greater than 1.5 times the upper limit of normal (ULN), and activated partial thromboplastin time (APTT) no greater than 1.5 times ULN. Participants receiving anticoagulation are eligible if coagulation parameters are within the expected therapeutic range.- Total serum bilirubin no greater than 1.5 times ULN; for participants with Gilbert syndrome, total bilirubin no greater than 3 times ULN. - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) no greater than 2.5 times ULN, or no greater than 5 times ULN in participants with documented liver metastases.- Serum creatinine no greater than 1.5 times ULN and creatinine clearance of at least 60 mL\u002Fmin for participants who received cisplatin or greater than 45 mL\u002Fmin for participants who received carboplatin, calculated using the Cockcroft-Gault formula. - Serum amylase and\u002For lipase no greater than 1.5 times ULN.\n* 9\\. At least one measurable lesion according to RECIST v1.1 before initiation of first-line induction therapy. Participants who achieve a CR and have no measurable lesion at maintenance-study entry remain eligible for progression-free survival (PFS) follow-up.\n* 10\\. Participants with central nervous system (CNS) metastases may be enrolled if previous CNS metastases have received local treatment with surgery and\u002For radiotherapy at least 2 weeks before enrollment, neurological symptoms are absent or stable, and treatment-related adverse events have recovered to grade 1 or lower. Participants should not require ongoing antiepileptic treatment. If corticosteroids are clinically required, the dose must be stable and no greater than 10 mg\u002Fday prednisone or equivalent.\n* 11\\. Participants of reproductive potential must agree to use an effective method of contraception during the study and for at least 3 months after the last study treatment. Women of childbearing potential must have a negative serum or urine pregnancy test before enrollment.\n\nExclusion Criteria:\n\n* 1\\. Known hypersensitivity to oral paclitaxel, an immune checkpoint inhibitor, or any component of the study drugs.\n* 2\\. Requirement for long-term treatment with a strong P-glycoprotein inhibitor that cannot be discontinued during the study.\n* 3\\. A gastrointestinal disorder within 6 months before the first study treatment that may substantially interfere with oral drug absorption, including complete intestinal obstruction. Previous gastrectomy alone is not an exclusion criterion.\n* 4\\. Active autoimmune disease or a history of autoimmune disease, including but not limited to interstitial pneumonitis, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, or nephritis. Participants with vitiligo, well-controlled type 1 diabetes mellitus, or hypothyroidism requiring only hormone-replacement therapy may be enrolled.\n* 5\\. Any of the following during previous immune checkpoint inhibitor (ICI) treatment: - Immune-related pneumonitis, immune-related myocarditis, or immune-related neurological toxicity of any grade. - Other grade 3 or higher immune-related adverse events (irAE) that have not recovered to grade 1 or lower or to baseline. - Grade 3 or higher irAE during first-line induction that have not recovered to grade 1 or lower or to baseline. - Permanent discontinuation of the ICI because of immune-related toxicity.\n* 6\\. Major surgery within 28 days before the first study treatment without adequate recovery, or planned major surgery during the study.\n* 7\\. Active hepatitis, active tuberculosis, or another serious infection requiring systemic treatment, including active hepatitis C virus (HCV) infection, except for participants who are HCV antibody-positive but RNA-negative; active hepatitis B virus (HBV) infection with positive HBV surface antigen and HBV DNA greater than 2,000 IU\u002FmL; bacteremia; or severe infectious pneumonia.\n* 8\\. Uncontrolled or serious cardiovascular disease, including: - Myocardial infarction, unstable angina, congestive heart failure of New York Heart Association class 2 or higher, or another serious cardiac disorder within 6 months before the first study treatment. - A clinically significant electrocardiographic (ECG) abnormality, including clinically significant arrhythmia or corrected QT interval greater than 450 milliseconds.- Left ventricular ejection fraction below 50% on echocardiography.\n* 9\\. Inability or unwillingness to comply with protocol requirements, or any condition that, in the investigator's judgment, makes the participant unsuitable for study participation.","ALL","18 Years","75 Years",{"count":21,"type":22},107,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","This study will evaluate the efficacy and safety of metronomic oral paclitaxel combined with a PD-1 or PD-L1 inhibitor as maintenance therapy in patients with advanced lung cancer whose disease has not progressed after first-line chemoimmunotherapy.\n\nThe study will include two independently analyzed cohorts. Cohort A will include patients with advanced squamous non-small cell lung cancer(sqNSCLC), and Cohort B will include patients with extensive-stage small cell lung cancer(ES-SCLC). All participants will receive oral paclitaxel three times weekly together with the same immune checkpoint inhibitor used during first-line induction therapy, whenever feasible.\n\nThe primary outcome is progression-free survival. Other outcomes include tumor response, overall survival, adverse events, treatment tolerability, and quality of life. Approximately 107 participants will be enrolled across multiple study centers.",[28,29],"Squamous Non-Small Cell Lung Cancer sqNSCLC","Extensive-stage Small Cell Lung Cancer (ES-SCLC)",[31,32,33,34,35,36,37,38,39,40],"Oral paclitaxel","Metronomic chemotherapy","Maintenance therapy","Immune checkpoint inhibitor","PD-1 inhibitor","PD-L1 inhibitor","sqNSCLC","ES-SCLC","Chemoimmunotherapy","First-line maintenance therapy","RECRUITING","2026-08-02",{"date":44,"type":45},"2026-08-04","ACTUAL",{"date":47,"type":45},"2026-07-24",{"date":49,"type":22},"2029-06",{"name":51,"class":52},"Anhui Provincial Cancer Hospital","OTHER",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":23,"phases":64,"briefSummary":66,"conditions":67,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":4},"100638941","phase-1-evaluate-the-safety-tolerability-and-preliminary-efficacy-of-evm14-in-combination-with-ivonescimab-in-sq-nsclc-patients-100638941","NCT07614646","Evaluate the Safety, Tolerability, and Preliminary Efficacy of EVM14 in Combination With Ivonescimab in Sq-NSCLC Patients","A Phase Ia Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of EVM14 Combined With Ivonescimab in Patients With Squamous Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Pathologically confirmed locally advanced (Stage IIIB\u002FIIIC) or metastatic (Stage IV) squamous non-small-cell lung cancer (sq-NSCLC), which is unresectable or not curable by definitive concurrent\u002Fsequential chemoradiotherapy.\n2. Known positive PD-L1 expression in tumor tissue prior to enrollment, with Tumor Proportion Score (TPS) ≥ 1% assessed via the 22C3 assay.\n3. No prior systemic anti-tumor therapy. Neoadjuvant\u002Fadjuvant systemic chemoradiotherapy for curative intent in non-metastatic disease, or definitive concurrent\u002Fsequential chemoradiotherapy for locally advanced disease, are permitted, provided disease progression occurs ≥ 6 months after the last treatment.\n4. Patients with at least 1 measurable lesion as defined per RECIST v1.1.\n5. Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.\n6. Life expectancy ≥ 6 months.\n7. Patients must have adequate organ function.\n\nExclusion Criteria:\n\n1. Has disease that is suitable for local treatment administered with curative intent.\n2. Cannot provide sufficient tumor slides for biomarker testing.\n3. Has a diagnosed and\u002For treated additional malignancy within 5 years prior to the first dose of study treatment except for: curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, and curatively resected in situ breast, cervical cancer, and prostate cancer.\n4. Active central nervous system (CNS) metastases. Patients with clinically stable brain metastases are eligible for enrollment.\n5. Has active autoimmune disease that has required systemic treatment in past 2 years or history of autoimmune disease that has possibility of relapse or at risk of having these conditions.\n6. Has received prior systemic anti-angiogenic therapy or any tumor-directed immunotherapy\n7. The left ventricular ejection fraction (LVEF) \\\u003C 50% during the screening period.\n8. Patients known to be human immunodeficiency virus (HIV)-positive.","99 Years",{"count":63,"type":22},13,[65],"PHASE1","The purpose of this clinical trial is to evaluate the safety, tolerability, preliminary efficacy, and immunogenicity of EVM14 administered intramuscularly (IM) combination with Ivonescimab in patients with sq-NSCLC.",[28],"NOT_YET_RECRUITING","2026-05-28",{"date":71,"type":45},"2026-05-29",{"date":73,"type":22},"2026-07",{"date":75,"type":22},"2028-07",{"name":77,"class":78},"Everest Medicines (Beijing) Co., Ltd.","INDUSTRY",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":23,"phases":89,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":4},"100573506","phase-2-efficacy-and-safety-of-sintilimab-combined-with-nab-pp-plus-rh-endostatin-in-locally-advancedadvanced-and-recurrent-metastatic-squamous-non-small-cell-lung-cancer-a-single-arm-multicenter-clinical-study-100573506","NCT06747169","Efficacy and Safety of Sintilimab Combined with Nab-PP Plus Rh-endostatin in Locally Advanced\u002Fadvanced and Recurrent Metastatic Squamous Non-small Cell Lung Cancer: a Single-arm, Multicenter Clinical Study","Efficacy and Safety of PD-1 Inhibitor Combined with Nab-PP Plus Rh-endostatin in Locally Advanced\u002Fadvanced and Recurrent Metastatic Squamous Non-small Cell Lung Cancer: a Single-arm, Multicenter Clinical Study","Inclusion Criteria:\n\n1. Patients must voluntarily participate in the study and provide written informed consent.\n2. Age between 18 and 70 years, applicable to both sexes.\n3. Histologically or cytologically confirmed advanced or metastatic (Stage IIIB, IIIC, or IV) squamous NSCLC without driver gene mutations.\n4. At least one measurable target lesion per RECIST 1.1 criteria, untreated with local therapies (e.g., radiotherapy).\n5. ECOG performance status score of 0-1.\n6. Expected survival ≥ 3 months.\n7. Treatment-naïve patients (no prior systemic anti-tumor therapy, including radiotherapy, chemotherapy, targeted, or immunotherapy), or patients with recurrence ≥ 6 months after adjuvant chemotherapy.\n8. Adequate organ function within 7 days prior to treatment:\n\n1）Hematology (without recent blood transfusion): Hemoglobin (HB) ≥ 90 g\u002FL Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL Platelets (PLT) ≥ 80 × 10⁹\u002FL 2）Biochemistry: Total bilirubin (TBIL) ≤ 1.5 × ULN ALT and AST ≤ 2.5 × ULN (≤ 5 × ULN for liver metastases) Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance (CCr) ≥ 60 mL\u002Fmin Serum albumin ≥ 35 g\u002FL 3) Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%. 9.Tissue samples required for biomarker analysis (e.g., PD-L1): newly obtained samples are preferred. Archived samples (collected within 2 years prior to enrollment) are acceptable, with 3-5 μm paraffin sections (5-8 slides).\n\nExclusion Criteria:\n\n1. History of severe hypersensitivity or allergic reactions to humanized antibodies or fusion proteins.\n2. Known hypersensitivity to recombinant human endostatin or any component of antibody preparations.\n3. Diagnosed with immunodeficiency or receiving systemic corticosteroids or other immunosuppressive therapies within 14 days prior to the first dose of study treatment (physiologic doses of corticosteroids, such as ≤10 mg\u002Fday prednisone or equivalent, are allowed).\n4. Active, known, or suspected autoimmune diseases (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hypothyroidism). However, patients with Type 1 diabetes, hypothyroidism requiring only hormone replacement, skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia), or autoimmune conditions not expected to recur in the absence of external triggers may be included.\n5. Pre-existing severe cardiac conditions, including congestive heart failure, uncontrolled high-risk arrhythmias, unstable angina, myocardial infarction, or severe valvular disease.\n6. Prior treatment with anti-angiogenic drugs (e.g., bevacizumab, sunitinib, sorafenib, imatinib, famitinib, regorafenib, apatinib, anlotinib).\n7. Planned systemic anti-tumor therapy (e.g., cytotoxic therapy) within 4 weeks before randomization or during the study.\n8. Active hepatitis B (HBV DNA ≥2000 IU\u002Fml or 10⁴ copies\u002Fml) or active hepatitis C (positive anti-HCV and detectable HCV RNA).\n9. Active tuberculosis (TB) infection based on chest X-ray, sputum examination, or clinical assessment. Patients with a history of active TB within the past year, even if treated, are excluded. Patients with a history of TB more than one year ago may participate only if prior anti-TB treatment was deemed appropriate.\n10. Symptomatic brain metastases or brain metastases with symptom control \\\u003C2 months.\n11. Major surgical procedures, incisional biopsy, or significant traumatic injuries within 28 days prior to randomization.\n12. Tumors invading major blood vessels or with a high risk of vascular invasion and fatal hemorrhage, as determined by investigators.\n13. Evidence or history of bleeding diathesis, regardless of severity. Patients with unresolved wounds, ulcers, or fractures, or those experiencing bleeding events ≥CTCAE Grade 3 within 4 weeks prior to randomization are excluded.\n14. Venous or arterial thrombotic events (e.g., stroke, transient ischemic attack, deep vein thrombosis, pulmonary embolism) within the past 6 months.\n15. Any comorbidity that, in the investigator's judgment, pose a significant risk to patient safety or interfere with study completion.","70 Years",{"count":88,"type":22},32,[90],"PHASE2","The goal of this single-arm, multi-center phase II clinical study is to evaluate the efficacy and safety of recombinant human endostatin (rh-Endostatin) combined with nab-paclitaxel, platinum-based chemotherapy, and PD-1 inhibitors in patients with locally advanced, advanced, or recurrent metastatic squamous non-small cell lung cancer (NSCLC).\n\nThe main questions it aims to answer are:\n\nWhat is the progression-free survival (PFS) and objective response rate (ORR) of this combination therapy? What is the safety profile, including adverse event (AE) and serious adverse event (SAE) rates? Researchers will compare the treatment effects over time by evaluating tumor responses using RECIST 1.1 criteria and assessing quality of life using the EORTC QLQ-C30 (v3.0) and QLQ-CX24 scales.\n\nParticipants will:\n\nReceive 4-6 cycles of rh-Endostatin combined with nab-paclitaxel, platinum-based chemotherapy, and PD-1 inhibitors.\n\nContinue maintenance treatment with rh-Endostatin and PD-1 inhibitors until disease progression or intolerable toxicity.",[93],"Squamous Non-Small Cell Lung Cancer SqNSCLC","2024-12-20",{"date":96,"type":45},"2024-12-27",{"date":98,"type":22},"2024-12-17",{"date":100,"type":22},"2026-12-17",{"name":102,"class":52},"Jian-Guo Zhou, MD, PhD"]