[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"resectable-non-small-cell-lung-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:resectable-non-small-cell-lung-cancer":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,42,70,97,127,150],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100617439","phase-1-nk-cell-therapy-combined-with-pd-1-antibody-and-platinum-based-chemotherapy-as-neoadjuvant-therapy-in-resectable-nsclc-100617439",false,"NCT07318636","NK-cell Therapy Combined With PD-1 Antibody and Platinum-Based Chemotherapy as Neoadjuvant Therapy in Resectable NSCLC","An Open-Label, Single-Arm Study Evaluating the Safety and Efficacy of NK010 Cell Injection Combined With PD-1 Antibody and Platinum-Based Chemotherapy as Neoadjuvant Therapy in Patients With Resectable Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Able to understand and voluntarily sign the written informed consent form (ICF).\n* Male or female patients aged ≥18 years.\n* Histologically and\u002For cytologically confirmed resectable stage IB to IIIA non-small cell lung cancer (NSCLC) according to AJCC 8th edition.\n* Treatment-naïve NSCLC (no prior systemic anticancer therapy).\n* No sensitizing EGFR mutations (exon 19 deletion, exon 21 L858R) and no ALK gene rearrangement.\n* At least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n* Estimated life expectancy of more than 6 months.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n* Adequate bone marrow, liver, and renal function.\n* Female participants of childbearing potential must have a negative pregnancy test prior to initiation of study treatment.\n\nExclusion Criteria:\n\n* Prior receipt of any systemic anticancer therapy.\n* Known sensitizing EGFR mutations or ALK gene rearrangements.\n* Active, known, or suspected autoimmune disease.\n* Interstitial lung disease.\n* Any medical condition, therapy, or laboratory abnormality that, in the opinion of the investigator, could confound the study results, interfere with the participant's ability to comply with study procedures, or is not in the best interest of the participant.\n* Locally advanced unresectable or metastatic NSCLC.\n* Major cardiovascular events, unstable arrhythmia, or unstable angina within 3 months prior to study treatment initiation.\n* Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use effective contraception during the study.\n* Any other condition judged by the investigator to make the participant unsuitable for clinical trial participation.","ALL","18 Years",{"count":19,"type":20},10,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This open-label, single-arm study is designed to evaluate the safety and preliminary efficacy of NK010 cell injection combined with a PD-1 antibody and platinum-based chemotherapy as neoadjuvant therapy in patients with resectable non-small cell lung cancer (NSCLC). The study aims to assess the safety profile, feasibility of administration, and potential antitumor activity of this combination regimen.",[26],"Resectable Non-small Cell Lung Cancer",[28],"Non-Small Cell Lung Cancer","NOT_YET_RECRUITING","2026-01-04",{"date":32,"type":33},"2026-01-06","ACTUAL",{"date":35,"type":20},"2026-01-20",{"date":37,"type":20},"2027-12-30",{"name":39,"class":40},"The First Affiliated Hospital of Guangzhou Medical University","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":5},"100595900","phase-2-a-multicenter-phase-ii-randomized-trial-of-limertinib-followed-by-sintilimab-and-chemotherapy-vs-limertinib-followed-by-limertinib-and-chemotherapy-as-neoadjuvant-therapy-in-resectable-stage-ii-iiib-egfr-mutant-nsclc-100595900","NCT07038460","A Multicenter Phase II Randomized Trial of Limertinib Followed by Sintilimab and Chemotherapy vs. Limertinib Followed by Limertinib and Chemotherapy as Neoadjuvant Therapy in Resectable Stage II-IIIB EGFR-Mutant NSCLC","NEO-LISI","Inclusion Criteria:\n\n1. Signed written informed consent form\n2. Age: 18-75 years.\n3. Cytologically\u002Fhistologically confirmed (via percutaneous lung puncture, bronchoscopy, mediastinoscopy, etc.), previously untreated stage II-IIIB (IASLC 8th Edition Thoracic Tumor Classification) lung adenocarcinoma.\n4. Tumor tissue or blood samples confirmed as EGFR-sensitive or rare mutation-positive by laboratory testing\n5. Must provide archived tumor tissue or newly resected tumor biopsy samples for PD-L1 IHC testing during screening.\n6. Eastern Cooperative Oncology Group (ECOG) performance status ≤1.\n7. Measurable lesions per RECIST v1.1.\n8. Surgically evaluated as eligible for local surgical resection (adequate pulmonary\u002Forgan function).Surgically evaluated as eligible for local surgical resection (adequate pulmonary\u002Forgan function).\n9. Adequate organ and bone marrow function (within 7 days prior to enrollment; no corrective therapies within 14 days prior to testing): • Hematology: ANC ≥1.5×10⁹\u002FL, platelets ≥100×10⁹\u002FL, hemoglobin ≥100 g\u002FL. • Hepatic: Total bilirubin ≤1.5×ULN; AST\u002FALT ≤2.5×ULN; albumin ≥35 g\u002FL. • Renal: Serum creatinine ≤1.5×ULN; CrCl ≥60 mL\u002Fmin (Cockcroft-Gault formula); urine protein \\\u003C2+ or 24-hour urine protein \\\u003C1 g. Cockcroft-Gault formula: • Female: CrCl = \\[(140 - age) × weight (kg) × 0.85\\] \u002F \\[72 × serum creatinine (mg\u002FdL)\\]. • Male: CrCl = \\[(140 - age) × weight (kg)\\] \u002F \\[72 × serum creatinine (mg\u002FdL)\\]. • Coagulation: INR ≤1.5×ULN; PT\u002FAPTT ≤1.5×ULN.\n10. For women of childbearing potential: Negative urine\u002Fserum pregnancy test within 7 days prior to first dose. Confirmatory blood test required if urine test is positive.\n\nExclusion Criteria:\n\n1. Patients with stage I or IV NSCLC who have previously received systemic anti-tumor therapies (e.g., ICIs, targeted therapy, chemotherapy).\n2. Active known or suspected autoimmune diseases (exceptions: type I diabetes, hypothyroidism requiring hormone replacement only, non-progressive skin conditions like vitiligo\u002Fpsoriasis\u002Falopecia).\n3. Active hepatitis B (HBsAg-positive) or hepatitis C (HCV RNA-positive). Patients with resolved HBV infection (HBsAg-negative, HBcAb-positive) must provide HBV DNA-negative results. HCV antibody-positive patients require negative HCV RNA PCR.\n4. HIV-positive or AIDS history.\n5. Arterial thrombosis within 6 months, or deep vein thrombosis\u002Fpulmonary embolism within 3 months.\n6. Uncontrolled angina, arrhythmias, or congestive heart failure.\n7. Active malignancies within 5 years (except cured cervical\u002Fcutaneous carcinoma in situ, superficial bladder\u002Fprostate\u002Fbreast cancer).\n8. Contraindications to local therapies (surgery, radiotherapy, or intervention) per investigator judgment.\n9. Hypersensitivity to sintilimab, limertinib, chemotherapy agents, or excipients.\n10. Unwillingness to sign informed consent or comply with follow-up.\n11. Any condition compromising trial integrity or patient safety, as judged by the investigator.","75 Years",{"count":51,"type":20},134,[53],"PHASE2","This clinical trial aims to evaluate the efficacy and safety of neoadjuvant therapy with Limertinib Followed by Sintilimab and Chemotherapy in resectable Stage II-IIIB EGFR-Mutant NSCLC. Untreated stage II-IIIB NSCLC (AJCC 8th edition) patients assessed as surgically resectable by investigators will be randomized 1:1 into the experimental or control group after signing informed consent and meeting eligibility criteria. All patients receive Limertinib for 6 weeks. Within 7 days thereafter, imaging assessment will be performed. If no progression is observed, experimental group patients discontinue therapy for 1 week, then receive Sintilimab + Carboplatin\u002FCisplatin + Pemetrexed every 3 weeks for 3 cycles; control group patients receive Limertinib for 9 weeks and Carboplatin\u002FCisplatin + Pemetrexed every 3 weeks for 3 cycles. Preoperative tumor assessment is required. Surgery will be performed 2-6 weeks (±7 days) after the first dose of the final cycle. Then patients will recieve 2-year adjuvant Osimertinib starting 1 month post-surgery. If imaging assessment after 6 weeks of limertinib treatment shows lesion enlargement but remains confined to stage II-IIIB, the investigator will decide whether the patient continues study treatment or not; if progression occurs to unresectable stage III or advanced disease, the patient must discontinue. The primary endpoint is pathological complete response (pCR) rate.",[26],[57,58,59,60],"NSCLC","EGFRmut","Limertinib","Sintilimab","2025-06-18",{"date":63,"type":33},"2025-06-26",{"date":65,"type":20},"2025-07",{"date":67,"type":20},"2029-12",{"name":69,"class":40},"Wen-zhao ZHONG",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":4},"100588855","phase-2-comparison-of-neoadjuvant-cadonilimab-versus-chemotherapy-combined-with-pd-1-in-the-treatment-of-resectable-non-small-cell-lung-cancer-with-high-pd-l1-expression-a-single-center-randomized-exploratory-clinical-study-100588855","NCT06946836","Comparison of Neoadjuvant Cadonilimab Versus Chemotherapy Combined With PD-1 in the Treatment of Resectable Non-Small Cell Lung Cancer With High PD-L1 Expression: A Single-Center, Randomized, Exploratory Clinical Study","Neoadjuvant","Inclusion Criteria:\n\n* The patient shall sign the Informed Consent Form.\n\n  1. Aged 18 ≥ years.\n  2. Histological or cytological diagnosis of NSCLC by needle biopsy, and stage IB-IIIA confirmed by imageological examinations (CT, PET-CT or EBUS) and Treatment-naïve for relevant antitumor therapy .\n  3. Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.\n  4. Life expectancy is at least 12 weeks.\n  5. At least 1 measurable lesion according to RECIST 1.1.\n  6. Patients with good function of other main organs (liver, kidney, blood system, etc.)\n  7. Patients with lung function can tolerate surgery;\n  8. Without systematic metastasis (including M1a, M1b and M1c);\n  9. Fertile female patients must voluntarily use effective contraceptives not less than 120 days after chemotherapy or the last dose of serplulimab (whichever is later) during the study period, and urine or serum pregnancy test results within 7 days prior to enrollment are negative.\n  10. Unsterilized male patients must voluntarily use effective contraception during the study period not less than 120 days after chemotherapy or the last dose of serplulimab (whichever is later).\n\nExclusion Criteria:\n\n* 1.Histology suggestive of small cell component and Participants who have received any systemic anti-cancer treatment for thymic epithelial tumor, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment; 2. Participants with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (\\>= NYHA) Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases; 3. With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment; 4. Participants who are allergic to the test drug or any auxiliary materials; 5. Participants with Interstitial lung disease currently; 6. Participants with active hepatitis B, hepatitis C or HIV; 7. Pregnant or lactating women; 8. Participants suffering from nervous system diseases or mental dieases that cannot cooperate; 9.Participated in another therapeutic clinical study; Other factors that researchers think it is not suitable for enrollment.",{"count":78,"type":20},80,[53],"The advent of immunotherapy has changed the treatment landscape for patients with non-small cell lung cancer. It has become the mainstay of perioperative treatment for patients with resectable non-small cell lung cancer。 Cadonilimab is the world's first bispecific antibody drug targeting PD-1 and CTLA-4. Previous studies on AK104 have demonstrated preliminary efficacy in both treatment-naïve advanced NSCLC patients and immunotherapy-resistant patients, showing a favorable safety and tolerability profile. This study aims to evaluate the effectiveness of neoadjuvant bispecific antibody AK104 compared with neoadjuvant chemotherapy combined with a PD-1 inhibitor in the treatment of resectable non-small cell lung cancer (NSCLC) with high PD-L1 expression.",[26,82,83],"Bispecific Antibody","Neoadjuvant Therapy",[85,86,87],"Resectable non-small cell lung cancer","bispecific antibody","Neoadjuvant therapy","2025-04-19",{"date":90,"type":33},"2025-04-27",{"date":92,"type":20},"2025-04-21",{"date":94,"type":20},"2031-05-11",{"name":96,"class":40},"Shanghai Pulmonary Hospital, Shanghai, China",{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":104,"enrollmentInfo":105,"targetDuration":4,"studyType":21,"phases":107,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":41},"100562804","neoadjuvant-with-t1-plus-immuno-chemotherapy-for-resectable-nsclc-100562804","NCT06607926","Neoadjuvant With Tα1 Plus Immuno-chemotherapy for Resectable NSCLC","Efficacy and Safety of Thymosin α1 Plus Immune Checkpoint Inhibitors and Chemotherapy as Neoadjuvant Therapy in Patients With Resectable Stage II - IIIB Non Small Cell Lung Cancer: A Prospective, Multicenter, Randomized, Controlled Trial","Inclusion Criteria:\n\n* Males and females aged ≥ 18 years and ≤ 70 years\n* With operable NSCLC confirmed by imaging studies and histopathology. (Stage II-IIIB\\[N2\\], according to the 8th Edition of the American Joint Committee on Cancer (AJCC-TNM) Staging Manual). Operable NSCLC, as defined by the Multidisciplinary Consensus Statement on the Clinical Management of Patients with Stage III Non-Small Cell Lung Cancer (2019 edition), includes resectable and potentially resectable cases. Resectable stage III NSCLC mainly includes stage IIIA N0-1, N2 with a single mediastinal lymph node metastasis and a short diameter \\< 2 cm and some T4N1 (with solitary carcinomatous nodules in different lobes of the same lung). Potentially resectable stage III NSCLC includes some IIIA and IIIB tumors, usually including a single N2 mediastinal lymph node with a short diameter \\< 3 cm, a potentially resectable superior sulcus tumor, and a potentially resectable T3 or T4 central tumor.\n* Presence of at least one measurable lesion on imaging as per the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n* Negative for EGFR and ALK driver mutations\n* With an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 - 1.\n* With a life expectancy \\> 6 months.\n* No prior systemic treatment (including surgery, chemotherapy, radiotherapy, targeted therapy, or immunotherapy) for lung cancer.\n* Informed consent to undergo radical surgery.\n* No contraindications to surgery, as assessed by a thoracic surgeon.\n* With adequate organ function, and with laboratory test results meeting the following criteria:\n\n  * Absolute neutrophil count (ANC) ≥ 1.5×10\\^9\u002FL without the use of granulocyte colony-stimulating factor in the past 14 days\n  * Platelet count ≥ 100×10\\^9\u002FL without blood transfusion in the past 14 days\n  * Hemoglobin (Hb) level ≥ 90 g\u002FL without blood transfusion or erythropoietin administration in the past 14 days.\n  * Serum creatinine ≤ 1.5 × upper limit of normal (ULN) and creatinine clearance (calculated by the Cockcroft-Gault equation) ≥ 60 mL\u002Fmin.\n  * Total bilirubin ≤ 1.5×ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN.\n  * Good coagulation, defined as prothrombin time\u002Finternational normalized ratio (INR) ≤ 1.5 × ULN.\n  * Normal thyroid function, defined as thyroid-stimulating hormone (TSH) level within the reference range. Subjects with baseline TSH level beyond the normal range may also be enrolled if total T3 (or free T3) and free T4 levels are within the normal range.\n  * The cardiac enzyme levels are within the normal limits (enrollment is also permitted if the investigator deems laboratory abnormalities as clinically insignificant).\n* Females of childbearing potential must agree to use contraceptive methods throughout the study and for 6 months post-study. Patients must have a negative serum or urine pregnancy test within 7 days prior to enrollment and should not be lactating. Male patients must agree to use contraceptive methods throughout the study and for 6 months post-study.\n* Subjects have full understanding of the study and voluntarily sign the informed consent form before any trial-related procedure is initiated.\n\nExclusion Criteria:\n\n* History of other malignancies within 5 years prior to the initial dose, excluding radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For carcinoma in situ following radical resection.\n* Positive for EGFR and ALK driver mutations or unknown\n* Ongoing participation in another interventional clinical trial, or receipt of other investigational agents or devices within 4 weeks prior to the first dose.\n* Prior multidisciplinary treatment for lung cancer, including but not limited to surgery, radiotherapy, chemotherapy, and\u002For immunotherapy (e.g., PD-1 or PD-L1 inhibitors and CTLA-4 inhibitors).\n* Use of systemic therapy with anti-tumor traditional Chinese patent medicines or immunomodulatory drugs (including thymopeptides, interferons, and interleukins, except for topical use for pleural effusions) within 2 weeks before the first dose.\n* Active autoimmune disease necessitating systemic treatment (e.g., disease-modifying drugs, glucocorticoids, and immunosuppressants) within 2 years before the first dose. Replacement therapies such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency are not classified as systemic therapy.\n* Use of systemic glucocorticoid therapy (excluding intranasal, inhaled, or other topical applications) or any other immunosuppressive treatment within 7 days before the first dose. Note: Glucocorticoids at physiological doses (≤ 10 mg\u002Fday of prednisone or equivalent) are allowed.\n* History of allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation.\n* Allergic to the active substance or excipients of the study drug.\n* Incomplete recovery from toxicity and\u002For complications due to prior interventions (i.e., ≤ grade 1 or baseline, excluding fatigue and alopecia) before treatment initiation.\n* Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV-1\u002F2 antibody).\n* Untreated active hepatitis B, defined as positive HBsAg along with HBV-DNA levels exceeding the ULN as determined by the clinical laboratory of the research center. Note: Subjects with hepatitis B may be eligible if they meet the following criteria:\n\n  * The HBV viral load is \\< 1000 copies\u002FmL (200 IU\u002FmL) before the first dose, with subjects being required to undergo anti-HBV therapy throughout chemotherapy to prevent viral reactivation.\n  * For subjects with anti-HBc(+), HBsAg(-), anti-HBs(-), and HBV viral load (-), no HBV prophylaxis is required, although viral reactivation should be monitored closely.\n* Subjects with active hepatitis C virus (HCV) infection, defined as positive HCV antibody and HCV-RNA levels above the threshold of detection.\n* Administration of a live vaccine within 30 days before the first dose. Note: administration of inactivated influenza vaccine by injection within 30 days before the first dose is allowed; however, subjects with a history of administration of intranasal live attenuated influenza vaccines will be excluded.\n* Pregnant or lactating women.\n* Subjects with any severe or uncontrolled systemic condition, including but not limited to:\n\n  * Significant resting ECG abnormalities in rhythm, conduction, or morphology (e.g., complete left bundle branch block, second- and higher-degree heart block, ventricular arrhythmias, or atrial fibrillation), corresponding to severe and difficult-to-control symptoms.\n  * Unstable angina, congestive heart failure, or New York Heart Association (NYHA) class ≥ 2 chronic heart failure.\n  * History of arterial thrombosis, embolism, or ischemia, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months preceding enrollment.\n  * Uncontrolled blood pressure, with systolic blood pressure (SBP) \\> 140 mmHg or diastolic blood pressure (DBP) \\> 90 mmHg.\n  * History of non-infectious pneumonitis necessitating glucocorticoid therapy within 1 year before the first dose, or current clinically active interstitial lung disease.\n  * Active tuberculosis.\n  * Active or uncontrolled infection requiring systemic treatment.\n  * Clinically active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction.\n  * Liver diseases, including cirrhosis, decompensated liver disease, and acute\u002Fchronic active hepatitis.\n  * Poorly controlled diabetes mellitus, with fasting blood glucose (FBG) \\> 10 mmol\u002FL.\n  * Urine protein ≥++ on routine urinalysis, along with a 24-hour urine protein level of \\> 1.0 g.\n  * A psychiatric disorder that limits the patient's ability to comply with the treatment or to follow the protocol.\n* A history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study; or, any condition that is judged by the Investigator to be inappropriate for the study.","70 Years",{"count":106,"type":20},40,[108],"NA","This study aims to explore the efficacy and safety of thymosin α-1 (Tα1) plus chemotherapy and PD-1 inhibitors as neoadjuvant therapy for operable non-small cell lung cancer",[111],"Resectable Non-Small-Cell Lung Cancer",[113,114,115,116,117],"non-small-cell lung cancer","resectable","thymosin alpha-1","PD-1 inhibitor","pCR","2024-09-19",{"date":120,"type":33},"2024-09-23",{"date":122,"type":20},"2024-10-15",{"date":124,"type":20},"2025-12-30",{"name":126,"class":40},"Xuanwu Hospital, Beijing",{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":21,"phases":135,"briefSummary":137,"conditions":138,"keywords":139,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":4},"100553397","phase-3-a-prospective-cohort-study-of-neoadjuvant-chemotherapy-plus-sintillumab-in-the-treatment-of-resectable-nsclc-100553397","NCT06485557","A Prospective Cohort Study of Neoadjuvant Chemotherapy Plus Sintillumab in the Treatment of Resectable NSCLC","Inclusion Criteria:\n\n1. Subjects must sign the written informed consent form (ICF), and be able to follow the visits and relevant procedures specified in the protocol\n2. Age ≥ 18 years\n3. Cytologically or histologically confirmed primary NSCLC (including adenocarcinoma, squamous cell carcinoma, adenosquamous carcinoma)\n4. Subjects with Stage IIA (primary focus\\>4cm), IIIA or IIIB (resectable N2 only) disease based on the 8th edition of the TNM staging classification for lung cancer issued by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Classification (AJCC8), resectable N2 only refers to non-massive (defined as short diameter less than 3cm), discrete or single station N2 involvement.\n5. No EGFR sensitive mutations and ALK rearrangements should be tested in non-squamous non-small cell lung cancer, and will be not mandatory in squamous cell carcinoma\n6. Deemed radically resectable with curative intent\n7. Pulmonary function reached the standard of planned pneumonectomy ( FEV1 ≥ 50 % predicted value, MVV ≥ 50 % predicted value ), and there was no surgical contraindication\n8. Enough tissue samples for PD-L1 detection (Number of slices ≥ 6)\n9. At least one measurable lesion in line with RECIST V1.1\n10. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1\n11. Have not received any prior systemic anti-tumor therapy or local radiotherapy for NSCLC\n12. Have adequate organ and bone marrow function, and the laboratory examination values within 14 days prior to enrollment meet the following requirements (no blood components, cell growth factors, albumin and other intravenous or subcutaneously administered drugs to correct hematological or liver and kidney dysfunction were allowed within the first 14 days of obtaining laboratory tests), as follows:\n13. Hematological function was sufficient, defined as absolute neutrophil count ≥ 1.5 × 109 \u002F L, platelet count ≥ 100 × 109 \u002F L, hemoglobin ≥ 100g \u002F L;\n14. Full liver function, defined as total bilirubin level ≤ 1.5 × ULN, AST and ALT level ≤ 2.5 × ULN, albumin (ALB) ≥ 35g \u002F L;\n15. Renal function was sufficient, serum creatinine (Scr) ≤ 1.5 × ULN, creatinine clearance rate (CrCl) ≥ 60mL \u002F min (calculated by Cockcroft \u002F Gault formula) and urine routine test results showed that urinary protein (UPRO) \\< 2 + or 24-hour urinary protein \\< 1g;\n16. The international normalized ratio (INR) ≤ 1.5 × ULN, and prothrombin time (PT) or activated partial thromboplastin time (APTT) ≤ 1.5 × ULN within 7 days before treatment;\n17. For women of childbearing age, urine or serum pregnancy tests were negative for at least seven days prior to the first study drug administration. If the urine pregnancy test is positive, a blood pregnancy test is required;\n18. If there is a risk of conception, male and female patients need to use high-efficiency contraception (i.e., the method with an annual failure rate of less than 1 %) and continue until at least 180 days after discontinuation of the trial; Note: If abstinence is the normal lifestyle and preferred contraceptive method of the subjects, abstinence can be accepted as a contraceptive method.\n\nExclusion Criteria:\n\n1. Pathological examination showed that small cell carcinoma, neuroendocrine carcinoma, sarcoma, lymphoepithelioma-like carcinoma, salivary gland tumor and mesenchymal tumor components\n2. Tumor invasion of the diaphragm, mediastinum, heart, pericardium, large blood vessels (such as aorta), esophagus, vertebral body\n3. pulmonary sulcus tumor\n4. Contralateral lung nodules, it need biopsy if clinically suspected\n5. Subjects with confirmed or suspected brain metastases\n6. Currently participating in an interventional clinical study or treatment with another study drug or study device within 4 weeks prior to randomization\n7. Previous use of anti-PD-1, anti-PD-L1, anti-programmed death receptor ligand 2 (PD-L2) or anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) drugs or any other drugs acting on T cell co-stimulation or immune checkpoint pathways (such as OX40, CD137, etc.) and adoptive cellular immunotherapy\n8. Received drugs with immunomodulatory effects (including thymosin, interferon, interleukin) within the first 4 weeks of randomization\n9. Received live attenuated vaccine within the first 4 weeks of randomization（Or plan to receive live attenuated vaccine during the study period） Note: Acceptance of inactivated vaccine for seasonal influenza is permitted; however, live attenuated influenza vaccine is not allowed\n10. Need long-term systemic use of corticosteroids，received any other form of immunosuppressive therapy within 7 days before randomization Note: Nasal spray, inhalation or other local glucocorticoids or physiological doses of systemic glucocorticoids (≤ 10mg \u002F day prednisone or equal doses of drugs) or for pretreatment (such as prevention of contrast agent allergy) use is allowed\n11. A history of non-infectious pneumonia requiring glucocorticoid therapy or current interstitial lung disease (≥ grade 2) within the previous year of randomization\n12. Active autoimmune diseases, including but not limited to inflammatory bowel disease, such as ulcerative colitis or Crohn \\'s disease, that require systemic treatment ( such as the use of disease-modifying drugs, corticosteroids or immunosuppressants ), have occurred within the first two years of the randomization; diverticulitis; chylous diarrhea; systemic lupus erythematosus; sarcoidosis syndrome or wegener syndrome ( granuloma with polyangiitis); graves\\' disease; rheumatoid arthritis; multiple sclerosis; vasculitis; glomerular nephritis; antiphospholipid syndrome; pituitary inflammation; uveitis, etc. Alternative therapies (such as thyroxine, insulin, or physiological doses of corticosteroids for adrenal or pituitary dysfunction) are not considered as systemic treatments. Patients with positive autoimmune antibodies need to be evaluated by researchers to confirm that there is no autoimmune disease that requires systemic treatment before they can be enrolled\n13. Primary immunodeficiency disease\n14. Previous or current myocarditis\n15. Not fully recovered from toxicity and\u002For complications caused by any intervention before randomization (\\> grade 1 or not recovery to baseline)\n16. peripheral neuropathy ≥ grade 2\n17. Hereditary bleeding tendency or coagulation dysfunction, or a history of thrombosis: There have been any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary embolism.within the previous 6 months of randomization. Have a history of deep vein thrombosis or any other serious thromboembolism (implantable venous access port or catheter-derived thrombosis, or superficial venous thrombosis is not considered thromboembolism) within the previous 3 months of randomization\n18. Non-squamous NSCLC subjects who were unable or unwilling to receive folic acid or vitamin B12 supplementation\n19. Any unstable systemic disease or concurrent disease, including but not limited to:\n\n1）Active infection ( requiring anti-infective drugs or systemic anti-infective drugs used within the previous week of randomization ) ; 2）congestive heart failure \\[New York Heart Association, NYHA ≥ grade II\\]； 3）Severe arrhythmia, liver, kidney, or metabolic disease requiring medical treatment； 4）Untreated coronary atherosclerotic heart disease； 5）Have a history of gastrointestinal perforation and \u002F or fistula, a history of intestinal obstruction, extensive bowel resection or long-term chronic diarrhea within the previous 6 months.\n\n20.Received solid organ or blood system transplantation\n\n21.Have a history of HIV infection (HIV1\u002F2 antibody positive), active syphilis\n\n22.Tuberculosis, which is active or requires medical intervention at this stage, including but not limited to pulmonary tuberculosis\n\n23.Active Hepatitis B Subjects with hepatitis B who met the following criteria met the inclusion criteria: HBsAg (+) or HBcAb (+), HBV viral load \\< 2000 copies\u002Fml or \\< 200 IU\u002Fml or lower than the detection limit HBsAg Subjects with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-) do not need to receive prophylactic anti-HBV treatment, but need to closely monitor whether the virus is reactivated\n\n24.Active hepatitis C (HCV antibody positive and HCV-RNA level above the detection limit)\n\n25.Patients with malignant tumors other than confirmed NSCLC within the first 5 years of randomization, except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery, and thyroid papillary carcinoma after radical surgery\n\n26.Sintilimab and\u002For selected chemotherapy regimens (non-squamous NSCLC : pemetrexed plus cisplatin or carboplatin ; squamous NSCLC : Albumin paclitaxel plus cisplatin or carboplatin) active ingredients and\u002For any excipients have allergic reactions\n\n27.Pregnant or lactating women or women preparing to be pregnant or lactating during the study period\n\n28.Subjects are mental illness or drug abuse that may have an impact on compliance with the test requirements, and have a history of alcohol abuse\n\n29.Subjects with medical history, disease, treatment or laboratory abnormality which may interfere with the results of the trial, prevent the subject from participating in the study throughout the study, or the researchers believe that subjects in the study can not get the best interests of the subject Local or systemic diseases caused by non-malignant tumors, or secondary reactions to cancer, can lead to higher medical risks and\u002For uncertainty in survival evaluation.",{"count":134,"type":20},90,[136],"PHASE3","This study uses a prospective cohort design.Subjects are randomly divided into three groups (A, B, C) before surgery. Group A gets 3 cycles of sintilimab + chemo, Group B gets 2 cycles + 1 cycle, and Group C gets 1 cycle + 2 cycles.\n\nNon-squamous NSCLC subjects receive pemetrexed\u002Falbumin paclitaxel + platinum, while squamous NSCLC subjects get albumin paclitaxel + platinum.",[26],[57,75,140],"Sintillumab","2024-07-02",{"date":143,"type":33},"2024-07-03",{"date":145,"type":20},"2024-08-01",{"date":147,"type":20},"2026-08-01",{"name":149,"class":40},"Tang-Du Hospital",{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":160,"phases":4,"briefSummary":161,"conditions":162,"keywords":4,"overallStatus":163,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":41},"100529144","an-observational-study-to-evaluate-neoadjuvant-nivolumab-opdivo-in-combination-with-platinum-based-chemotherapy-in-non-metastatic-non-small-cell-lung-cancer-participants-in-germany-100529144","NCT06169956","An Observational Study to Evaluate Neoadjuvant Nivolumab (OPDIVO®) in Combination With Platinum-Based Chemotherapy in Non-Metastatic Non-Small Cell Lung Cancer Participants in Germany","Neoadjuvant Nivolumab (OPDIVO®) in Combination With Platinum-Based Chemotherapy for Non-Metastatic NSCLC: A German, Nationwide, Prospective, Observational, Multicenter Study in Patients Scheduled to Receive 3 Cycles Nivolumab in Combination With Platinum-Based Chemotherapy for Non-Metastatic (Stage and PD-L1 Expression According to Label) Non-Small Cell Lung Cancer","NENI","Inclusion Criteria:\n\n* Aged 18 years or older\n* Diagnosis of non-metastatic non-small cell lung cancer with tumor Programmed death-ligand 1 (PD-L1) expression level of 1% or more (tumor proportion score (TPS); according to label approved in the European Union)\n* Decision to initiate a neoadjuvant treatment with nivolumab plus platinum-based chemotherapy for treatment of non-small cell lung cancer according to current Summary of product characteristics and independent of the study\n* Willing to complete patient-reported outcome questionnaires and sufficient understanding of the German language\n* Signed written informed consent\n* Other criteria according to current Summary of product characteristics\n\nExclusion Criteria:\n\n* Current primary diagnosis of cancer other than non-small cell lung cancer that requires systemic or other treatment\n* Other contraindications according to current Summary of product characteristics",{"count":159,"type":20},400,"OBSERVATIONAL","The purpose of this observational study is to collect and evaluate real-world data to assess the effectiveness of neoadjuvant nivolumab when given in combination with platinum-based chemotherapy in participants with early-stage, resectable non-small cell lung cancer (NSCLC) in Germany",[26],"RECRUITING","2024-04-17",{"date":166,"type":33},"2024-04-18",{"date":168,"type":33},"2023-11-30",{"date":170,"type":20},"2030-09-30",{"name":172,"class":173},"Bristol-Myers Squibb","INDUSTRY"]