[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-small-cell-lung-carcinoma-nsclc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-small-cell-lung-carcinoma-nsclc":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,84,111],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100643662","phase-4-pharmacokinetic-study-of-pembrolizumab-and-its-impact-on-immunity-and-the-tumor-microenvironment-which-may-explain-the-efficacy-of-post-immunotherapy-chemotherapy-100643662",false,"NCT07633613","Pharmacokinetic Study of Pembrolizumab and Its Impact on Immunity and the Tumor Microenvironment, Which May Explain the Efficacy of Post-immunotherapy Chemotherapy.","CPI","Inclusion Criteria:\n\n\\- Patients over 18 years of age\n\n\\- Patients diagnosed with :\n\n1. Non-small cell lung cancer (NSCLC), including adenocarcinoma and squamous cell carcinoma.\n2. Head and neck squamous cell carcinoma, p16-negative for oropharyngeal tumors.\n\n   * Recurrent and\u002For metastatic tumor not amenable to curative locoregional treatment.\n   * Disease progression under Pembrolizumab immunotherapy, administered at the standard dose of 200 mg every 3 weeks, as first-line treatment for metastatic disease, regardless of the number of cycles received, either as monotherapy or in combination with chemotherapy, as defined below:\n\n     • For pulmonary adenocarcinomas: i. First-line treatment with Pembrolizumab in combination with a platinum agent (Carboplatin or Cisplatin) and Pemetrexed\n\n   ii. Maintenance therapy with Pembrolizumab, with or without Pemetrexed.\n\n   • For pulmonary squamous cell carcinomas: i. First-line treatment with Pembrolizumab in combination with a platinum agent (Carboplatin) and Paclitaxel\n\n   +\u002F- ii. Maintenance therapy with Pembrolizumab alone.\n\n   • For head and neck squamous cell carcinomas : i. First-line treatment with Pembrolizumab in combination with a platinum agent (Carboplatin or Cisplatin) ± 5-Fluorouracil (5-FU) or Paclitaxel\n\n   +\u002F- ii. Maintenance therapy with Pembrolizumab alone.\n   * Eligibility for salvage chemotherapy within standard care:\n\n     • For pulmonary adenocarcinomas: weekly Paclitaxel, with or without Bevacizumab.\n     * For pulmonary squamous cell carcinomas: Gemcitabine monotherapy.\n     * For head and neck squamous cell carcinomas: weekly Paclitaxel and\u002For Cetuximab. Standard salvage chemotherapy may be initiated between Day 18 and Day 35 following the last Pembrolizumab injection, at standard doses.\n   * Measurable disease according to RECIST 1.1 criteria.\n   * Performance status (PS) 0 to 2.\n   * Baseline laboratory results meeting the usual criteria permitting initiation of salvage chemotherapy.\n   * Patients who has voluntarily agreed to participate in the study (including additional blood sampling) and has signed the informed consent form.\n   * For the subpopulation with accessible tissue biopsy:\n\n     * Patient agrees to undergo biopsy,\n     * INR \\\u003C 1.5, Platelets \\> 50000\u002FμL.\n   * Patients covered by a social security health insurance scheme.\n\n   Exclusion Criteria:\n   * History of cancer, except for cancers in complete remission for more than 3 years, fully resected cutaneous basal cell carcinomas, or treated carcinoma in situ or cervical intraepithelial neoplasia (in situ cervical epithelioma),\n   * Patients participating in another clinical trial for which an exclusion period is specified,\n   * Minor patients,\n   * For the subpopulation with accessible tissue biopsy, patients receiving:\n\n     • Clopidogrel (hydrogen sulfate) or Prasugrel (hydrochloride) or Ticlopidine (hydrochloride) without the possibility of discontinuation for 5 days,\n\n     • Low-molecular-weight heparin (LMWH) without the possibility of dose suspension prior to the procedure,\n\n     • Or Fondaparinux without the possibility of discontinuation,\n\n     • Or Abciximab without the possibility of discontinuation for 24 hours and aPTT \\\u003C 50s and ACT \\\u003C 150s,\n\n     • Or Eptifibatide or Tirofiban hydrochloride monohydrate or Argatroban without the possibility of discontinuation 4 hours before the procedure,\n     * Or Bivalirudin without the possibility of discontinuation 2-3 hours before the procedure if CrCL \\> 50 mL\u002Fmin, or 3-5 hours if CrCL \\\u003C 50 mL\u002Fmin,\n     * Or Dabigatran etexilate without the possibility of discontinuation 2-3 days before the procedure if CrCL \\> 50 mL\u002Fmin, or 3-5 days if CrCL \\\u003C 50 mL\u002Fmin.\n   * Vulnerable persons as defined in Articles L1121-5 to L1121-8 :\n\n     • Pregnant women, women in labour, and breastfeeding mothers,\n     * Persons deprived of liberty by judicial or administrative decision, and persons hospitalized without consent under Articles L3212-1 and L3213-1 who do not fall under the provisions of Article L1121-8,\n     * Persons admitted to a health or social care institution for purposes other than research,\n     * Adults under legal protection measures or unable to express their consent.","ALL","18 Years",{"count":19,"type":20},110,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","This is a single-center pharmacokinetic study evaluating the impact of residual pembrolizumab levels on the efficacy of salvage chemotherapy following immunotherapy in patients with non-small cell lung cancer (NSCLC) or recurrent and\u002For metastatic head and neck squamous cell carcinoma (HNSCC) not amenable to curative local treatment.",[26,27],"Non-Small Cell Lung Carcinoma (NSCLC)","Metastatic Head and Neck Squamous Cell Carcinoma",[29,30,31,32],"Pembrolizumab","immunotherapy","salvage chemotherapy","pharmacokinetics","NOT_YET_RECRUITING","2026-06-04",{"date":36,"type":37},"2026-06-08","ACTUAL",{"date":39,"type":20},"2026-07",{"date":41,"type":20},"2028-12",{"name":43,"class":44},"Centre Antoine Lacassagne","OTHER",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":72,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":4},"100643697","phase-2-exploratory-study-on-the-efficacy-and-safety-of-trastuzumab-rezetecan-in-the-treatment-of-her2-expressiong-advanced-solid-tumor-100643697","NCT07631884","Exploratory Study on the Efficacy and Safety of Trastuzumab Rezetecan in the Treatment of HER2-Expressiong Advanced Solid Tumor","Inclusion Criteria:\n\n1. Male and female participants aged 18 years or older.\n2. Participants with locally advanced, unresectable or metastatic solid tumors who have progressed after at least one prior systemic therapy for advanced\u002Fmetastatic disease, or have no satisfactory alternative treatment options. Eligible tumor types include but are not limited to biliary tract cancer, endometrial cancer, urothelial carcinoma, pancreatic cancer, colorectal cancer, gastric cancer, non-small cell lung cancer, head and neck adenocarcinoma (salivary gland adenocarcinoma, lacrimal gland adenocarcinoma, adenocarcinoma of unknown primary in the neck), cervical cancer, ovarian cancer and adenocarcinoma of unknown primary. Breast cancer is excluded.\n3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.\n4. Confirmed HER2 expression defined as IHC 1+, 2+ or 3+ (per GC criteria).\n5. Willing and able to provide adequate tumor specimens for central pathological re-testing of HER2 status. For participants previously treated with anti-HER2 therapy, tumor specimens obtained after the last anti-HER2 treatment are optional.\n6. At least one measurable lesion at baseline per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n7. Adequate organ and bone marrow function within 14 days prior to enrollment, meeting the following criteria:\n\n   Hemoglobin ≥ 9 g\u002FdL; Platelet count ≥ 100,000\u002Fmm³; Absolute neutrophil count (ANC) ≥ 1500\u002Fmm³; Serum albumin ≥ 3.0 g\u002FdL; Prothrombin time (PT), activated partial thromboplastin time (aPTT) and International Normalized Ratio (INR) ≤ 1.5 × upper limit of normal (ULN); Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 × ULN; ≤ 5 × ULN for participants with liver metastases; Total bilirubin ≤ 1.5 × ULN for participants without liver metastases; ≤ 3 × ULN for participants with Gilbert's syndrome or liver metastases at baseline; Creatinine clearance ≥ 30 mL\u002Fmin (calculated by the Cockcroft-Gault formula)\n8. Left ventricular ejection fraction (LVEF) ≥ 50% assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days prior to enrollment.\n\nExclusion Criteria:\n\nParticipants meeting any of the following conditions are ineligible for this study:\n\n1. Presence of any severe and\u002For uncontrolled diseases:\n\n   * Poorly controlled blood pressure (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg); poorly controlled diabetes (fasting blood glucose \\[FBG\\] \\> 10 mmol\u002FL).\n   * Grade ≥ 2 myocardial ischemia, myocardial infarction, arrhythmia (QTc interval ≥ 470 ms), or Grade ≥ 2 congestive heart failure (per New York Heart Association \\[NYHA\\] classification).\n   * Active or uncontrolled severe infections (Grade ≥ 2 per NCI CTCAE) requiring systemic antibacterial, antifungal or antiviral therapy, including pulmonary tuberculosis.\n   * History of active tuberculosis.\n   * Uncontrolled ascites, pericardial effusion or pleural effusion requiring repeated drainage.\n2. Active hepatitis: Liver function not meeting the inclusion criteria. Hepatitis B: HBV DNA ≥ 2000 IU\u002FmL or ≥ 10\\^4 copies\u002FmL.Hepatitis C: HCV RNA ≥ 2000 IU\u002FmL or ≥ 10\\^4 copies\u002FmL. Participants with viral load below the above thresholds after nucleoside antiviral therapy are eligible. Chronic hepatitis B virus carriers with HBV DNA \\\u003C 10\\^4 IU\u002FmL must receive concurrent antiviral treatment throughout the study for enrollment.\n3. History of immunodeficiency diseases, including HIV positivity or other acquired\u002Fcongenital immunodeficiency disorders.\n4. History of allogeneic solid organ transplantation or allogeneic hematopoietic stem cell transplantation.\n5. Confirmed meningeal metastasis, spinal cord metastasis or spinal cord compression.\n6. Within 6 months prior to the first study drug administration, presence of esophageal gastric varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, acute gastrointestinal bleeding, extensive intestinal resection (partial colectomy or extensive small bowel resection complicated with chronic diarrhea), Crohn's disease, ulcerative colitis or long-standing chronic diarrhea.\n7. Unhealed or poorly healing wounds, or active ulcers.\n8. Toxicities from prior anti-tumor therapy have not resolved to Grade 0 or 1 per NCI CTCAE version 5.0.\n9. Received major surgery, incisional biopsy or significant traumatic injury within 28 days before study treatment initiation; or with long-standing unhealed wounds or fractures.\n10. History of severe hypersensitivity reactions to monoclonal antibodies; known allergy to the active ingredients or excipients of the study drug.",{"count":52,"type":20},15,[54],"PHASE2","The goal of this clinical trial is to learn if Trastuzumab Rezetecan can treat advanced solid tumors with HER-2 expression in adult participants.\n\nThe main question it aims to answer is: What is the objective response rate of Trastuzumab Rezetecan in adult patients with HER-2 expressed advanced solid tumors? Participants will receive intravenous infusion of Trastuzumab Rezetecan on Day 1 of each 21-day treatment cycle. The dosage is 4.8 mg\u002Fkg per cycle; participants with a body weight of 85 kg or above will receive a fixed dose of 408 mg every 3 weeks.",[57,58,59,60,61,62,63,64,65,66,67,68,69,26,70,71],"Solid Tumors","Neoplasms (Cancer \u002F Tumors)","Advanced Malignant Solid Neoplasm","Locally Advanced Malignant Solid Neoplasm","Unresectable Malignant Solid Neoplasm","Metastatic Malignant Solid Neoplasm","HER2 Expression","Biliary Tract Neoplasms","Endometrial Neoplasms","Urothelial Carcinoma (UC)","Pancreatic Neoplasms","Colorectal Neoplasms","Gastric Neoplasms","Head and Neck Neoplasms","Cervical Neoplasms",[73,74,75],"HER2 expression","Trastuzumab Rezetecan","Advanced Solid Tumor","2026-06-02",{"date":36,"type":37},{"date":79,"type":20},"2026-06-15",{"date":81,"type":20},"2028-12-31",{"name":83,"class":44},"Haihua Yuan",{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":91,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":5},"100621359","impact-of-chemotherapy-dose-reductions-on-survival-outcomes-among-older-nsclc-patients-without-actionable-mutations-100621359","NCT07369596","Impact of Chemotherapy Dose Reductions on Survival Outcomes Among Older NSCLC Patients Without Actionable Mutations","Impact of Chemotherapy Dose Reductions on Survival Outcomes Among Older NSCLC Patients Without Actionable Mutations: A Retrospective Cohort Study.","Inclusion Criteria:\n\n* Age ≥65 years\n* Histologically confirmed stage IV NSCLC\n* Negative for EGFR mutation, ALK rearrangement, and ROS1 fusion\n* Treated with at least ONE cycle of first-line chemotherapy\n\nExclusion Criteria:\n\n* Patients who received targeted therapy or immunotherapy as monotherapy in the first-line setting\n* Incomplete survival data","65 Years",{"count":93,"type":20},150,"OBSERVATIONAL","Evidence suggests that appropriately selected older adults can tolerate standard-dose chemotherapy and achieve survival outcomes comparable to younger patients. However, older adults are usually under-represented in clinical trials and often receive reduced doses of chemotherapy due to concerns regarding age-related frailty, polypharmacy, and toxicity.\n\nThis study seeks to evaluate chemotherapy dosing patterns and associated survival outcomes in older patients.",[97],"Non Small Cell Lung Carcinoma NSCLC",[99,100,101],"NSCLC","older patients","chemotherapy","RECRUITING","2026-05-30",{"date":76,"type":37},{"date":106,"type":37},"2026-01-01",{"date":108,"type":20},"2026-12-31",{"name":110,"class":44},"University of Malaya",{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":21,"phases":120,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":134},"100620810","phase-3-a-study-to-evaluate-the-safety-and-tolerability-of-sctb14-as-first-line-therapy-in-non-small-cell-lung-cancer-100620810","NCT07362459","A Study to Evaluate the Safety and Tolerability of SCTB14 as First-Line Therapy in Non-Small Cell Lung Cancer.","A Phase III, Randomized, Double-blind, Multicenter Clinical Study to Evaluate the Efficacy and Safety of SCTB14 Versus Pembrolizumab as First-Line Therapy in Patients With Driver Gene-Negative, TPS ≥10% Locally Advanced or Metastatic Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Voluntarily sign the written informed consent form prior to screening.\n2. Age ≥ 18 years, both male and female.\n3. ECOG Performance Status score of 0 to 1.\n4. An expected survival of ≥ 3 months.\n5. Histologically or cytologically confirmed, unresectable locally advanced (Stage IIIB\u002FIIIC) or metastatic (Stage IV) Non-Small Cell Lung Cancer (NSCLC) that is not amenable to curative surgery or radical concurrent\u002Fsequential chemoradiotherapy.\n6. For subjects with non-squamous cell carcinoma, as well as non-smoking subjects with squamous cell carcinoma containing mixed adenocarcinoma components, confirmation of the absence of EGFR sensitizing mutations or ALK gene rearrangements from tumor tissue is required prior to enrollment.\n7. Subjects must provide a histology sample suitable for PD-L1 testing, with a Tumor Proportion Score (TPS) ≥ 10%.\n8. No prior systemic anti-tumor therapy for the studied disease.\n9. At least one measurable non-CNS lesion according to RECIST v1.1 criteria.\n10. Adequate function of major organs.\n\nExclusion Criteria:\n\n1. Known actionable driver gene mutations such as ROS1 fusion, BRAF V600E mutation, NTRK fusion, MET exon 14 skipping mutation, and RET fusion mutation.\n2. Received non-specific immunomodulatory therapy or immunosuppressive drugs within 2 weeks before the first dose; received traditional Chinese medicine with antineoplastic indications within 1 week before the first dose.\n3. Prior thoracic radiotherapy; or local anti-tumor therapy within 2 weeks before first dosing.\n4. Prior treatment with antitumor immunotherapy, antiangiogenic therapy, or other small molecule tyrosine kinase inhibitor (TKI)-based antitumor drugs.\n5. subjects with metastasis or compression involving the brainstem, meninges, or spinal cord, or those with active CNS metastases or multiple brain metastases.\n6. Imaging demonstrates tumor invasion of major blood vessels, significant necrosis or cavitation within the primary tumor lesions, or the presence of lymphangitic carcinomatosis.\n7. Imaging demonstrates tumor invasion or compression of adjacent vital organs or carries a risk of developing an esophagotracheal fistula or esophagopleural fistula.\n8. History of hypertensive crisis or hypertensive encephalopathy, or the presence of uncontrolled hypertension despite medication, or poorly controlled diabetes despite pharmacotherapy.\n9. A history of arterial thrombosis, deep vein thrombosis, cerebral infarction, transient ischemic attack, or significant vascular disease within 6 months prior to enrollment.\n10. A history of myocardial infarction, unstable angina, cardiac insufficiency with New York Heart Association (NYHA) class ≥ III, or severe arrhythmia uncontrolled by medication within 6 months prior to enrollment.\n11. The presence of any active autoimmune disease or a history of autoimmune disease with an anticipated recurrence.\n12. A history of esophageal\u002Fgastric varices, severe ulcer, abdominal fistula, intra-abdominal abscess, gastrointestinal perforation and\u002For fistula, acute gastrointestinal bleeding, intestinal obstruction, or extensive intestinal resection within 6 months prior to the first dose.\n13. A history of bleeding tendency, high bleeding risk, or coagulation dysfunction,.\n14. The presence of other malignant tumors.\n15. Toxicities from prior neoadjuvant\u002Fadjuvant therapy, surgery, radiotherapy, or other previous antitumor treatments have not recovered to Grade 0-1.\n16. Receipt of a live or attenuated vaccine within 4 weeks prior to the first dose, or a plan to receive a live or attenuated vaccine during the study period; however, the use of inactivated vaccines is permitted.\n17. Presence of any of the following infectious conditions: a) severe infection within 4 weeks prior to the first dose; b) active infection within 2 weeks prior to enrollment; c) active tuberculosis; d) positive HIV antibody; e) active hepatitis B or C; f) known active syphilis.\n18. Major surgery planned or anticipated during the study period, or unhealed tissue present before enrollment..\n19. Presence of symptomatic or recurrent pleural effusion, pericardial effusion, or ascites requiring drainage.\n20. A history of non-infectious pneumonia requiring treatment or the presence of interstitial lung disease\n21. A history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n22. Known hypersensitivity to any component of the investigational drug or a documented history of severe hypersensitivity reactions to any other monoclonal antibody.\n23. Current participation in another clinical trial, with the exception of observational (non-interventional) studies or the follow-up phase of an interventional trial.\n24. Pregnancy or lactation in female subjects.\n25. A known history of alcohol or drug addiction, psychiatric disorders, or drug abuse in the subject.\n26. Tumor-induced conditions or symptoms associated with a high medical risk.\n27. Any other condition deemed by the investigator to be inappropriate for enrollment.",{"count":119,"type":20},246,[121],"PHASE3","This Phase III, randomized, double-blind study compares the efficacy and safety of SCTB14 versus pembrolizumab as first-line treatment in patients with driver gene-negative, TPS ≥10% locally advanced or metastatic non-small cell lung cancer (NSCLC). The primary objective is to assess superiority of SCTB14 over pembrolizumab in prolonging progression-free survival. Safety will be closely monitored.",[26],"2026-01-15",{"date":126,"type":37},"2026-01-23",{"date":128,"type":37},"2025-12-30",{"date":130,"type":20},"2029-09",{"name":132,"class":133},"Sinocelltech Ltd.","INDUSTRY",1]