[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nsclc-stage-ii\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nsclc-stage-ii":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,41,76,99,123,151],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100630923","phase-2-study-on-the-efficacy-and-safety-of-jskn016-as-neoadjuvant-therapy-in-resectable-stage-ii-iii-non-small-cell-lung-cancer-patients-100630923",false,"NCT07493980","Study on the Efficacy and Safety of JSKN016 as Neoadjuvant Therapy in Resectable Stage II-III Non-small Cell Lung Cancer Patients","Study on the Efficacy and Safety of JSKN016 Combined With Toripalimab and Carboplatin as Neoadjuvant Therapy in Resectable Stage II-III Non-small Cell Lung Cancer Patients","Inclusion Criteria:\n\n* The subject is able to understand the informed consent form, voluntarily participate in the study, and has signed the informed consent form.\n* The subject is ≥18 years and ≤80 years of age on the day of signing the informed consent form; both males and females are eligible.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Histologically or cytologically confirmed resectable stage II, IIIA, or IIIB non-small cell lung cancer (NSCLC), according to the AJCC 9th edition TNM staging system for lung cancer.\n* The subject has not previously received any anti-tumor therapy, including but not limited to systemic chemotherapy, immunotherapy, targeted therapy, or radiotherapy. Subjects who have received traditional Chinese medicine for anti-tumor indications are permitted to enroll provided a washout period of at least 2 weeks has elapsed.\n* Tumor tissue genetic testing confirms NSCLC without EGFR sensitizing mutations (19del\u002FL858R) and negative for ALK fusion genes.\n\nNote: EGFR status may be determined using cytological or blood-based testing results. For subjects with squamous NSCLC, if EGFR and ALK status are previously unknown, testing is not required prior to enrollment in this study and will be considered negative.\n\n* At least one measurable lesion at baseline according to RECIST version 1.1.\n* Adequate organ function. The following laboratory test results must be obtained within 7 days prior to the first dose (echocardiography is permitted within 28 days prior to the first dose):\n\n  1. Bone marrow function (no transfusion of whole blood or blood components within 14 days before the first dose; no hematopoietic growth factors within 7 days before the first dose):\n\n     Absolute neutrophil count ≥ 1.5 × 10⁹\u002FL Hemoglobin ≥ 90 g\u002FL Platelet count ≥ 100 × 10⁹\u002FL\n  2. Liver function:\n\n     Total bilirubin ≤ 1.5 × upper limit of normal (ULN) ALT and AST ≤ 3 × ULN\n  3. Renal function:\n\n     Serum creatinine ≤ 1.5 × ULN, or creatinine clearance (Ccr) ≥ 50 mL\u002Fmin calculated using the Cockcroft-Gault formula (see Appendix 4)\n  4. Coagulation function:\n\n     International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN\n  5. Cardiac function:\n\n     Left ventricular ejection fraction (LVEF) ≥ 50% measured by echocardiography\n  6. Pulmonary function:\n\nPulmonary function considered adequate for surgery as determined by the investigator.\n\n* Female subjects of childbearing potential or male subjects whose partners are of childbearing potential must agree to use highly effective contraception from the time of signing the informed consent form until 24 weeks after the last dose. Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to the first dose.\n* The subject is able and willing to comply with study protocol requirements, including study visits, treatment plans, laboratory tests, and other study-related procedures.\n\nExclusion Criteria:\n\n* Histopathological evidence of any small cell carcinoma component, or diagnosis of large cell neuroendocrine carcinoma or sarcomatoid carcinoma.\n* Presence of another malignancy within 3 years prior to the first dose, except for tumors that have been clinically cured by local treatment and have an extremely low risk of recurrence (e.g., cutaneous squamous cell carcinoma, basal cell carcinoma of the skin, non-muscle-invasive bladder cancer, carcinoma in situ of the cervix, localized prostate cancer, etc.), or tumors with disease-free survival ≥ 3 years after curative treatment and an extremely low risk of recurrence or metastasis (e.g., ductal carcinoma in situ after radical surgery, papillary thyroid carcinoma after radical surgery, etc.).\n* Insufficient washout from prior treatments before the first dose, including:\n\n  1. Use of any investigational drug within 28 days prior to the first dose;\n  2. Use of traditional Chinese herbal medicine or proprietary Chinese medicine with clear anti-tumor indications within 14 days prior to the first dose;\n  3. Receipt of non-specific immunomodulatory therapy (e.g., interleukin, interferon, thymosin, tumor necrosis factor, etc.) within 14 days prior to the first dose;\n  4. Requirement for systemic glucocorticoids (\\>10 mg\u002Fday prednisone or equivalent doses of other glucocorticoids) for more than 7 consecutive days, or immunosuppressive therapy, within 14 days prior to the first dose.\n\n     Exceptions include inhaled or topical corticosteroids, or physiologic replacement doses for adrenal insufficiency. Short-term (≤7 days) corticosteroid use is permitted for prophylaxis (e.g., prevention of contrast-agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity due to allergen exposure);\n  5. Major surgery (e.g., abdominal or thoracic surgery) within 28 days prior to the first dose, excluding minor procedures such as diagnostic puncture, implantation of infusion devices, or biliary stent placement, or anticipated need for major surgery during the study period;\n  6. Receipt of live vaccines within 28 days prior to the first dose, or planned administration of live vaccines during the study period.\n* Presence of interstitial lung disease (ILD) or risk factors related to non-infectious pneumonitis, including:\n\n  1. History or current presence of ILD or non-infectious pneumonitis requiring systemic glucocorticoids or other immunosuppressive therapy;\n  2. Suspected ILD or non-infectious pneumonitis that cannot be excluded by imaging during the screening period.\n* Presence of active autoimmune disease requiring systemic treatment within the past 2 years (e.g., treatment with disease-modifying agents, corticosteroids, or immunosuppressive drugs).\n\nNote: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic treatment.\n\n* Uncontrolled infections, including but not limited to:\n\n  1. Active HBV or HCV infection. Patients positive for HBsAg must undergo HBV-DNA testing; if HBV-DNA exceeds the lower limit of detection of the local laboratory, enrollment is permitted provided antiviral therapy is administered.\n\n     Patients positive for HCV-Ab may be enrolled if HCV-RNA is negative;\n  2. Severe infection within 4 weeks prior to the first dose, including but not limited to infections with complications requiring hospitalization, sepsis, or severe pneumonia; or active infection requiring systemic anti-infective therapy within 2 weeks prior to the first dose;\n  3. History of immunodeficiency, positive HIV test, or history of acquired immunodeficiency syndrome (AIDS);\n  4. Known active tuberculosis;\n  5. Active syphilis.\n* History of allogeneic bone marrow transplantation or organ transplantation.\n* Known hypersensitivity to any component of the investigational drug, or a history of severe allergic reactions to other antibody-based therapies.\n* Pregnant or breastfeeding women, or women planning to become pregnant during the study period.\n* Known psychiatric disorders, substance abuse, alcohol abuse, or any other condition that, in the investigator's judgment, may affect the safety of study treatment or subject compliance.\n* Any other disease, treatment, or laboratory abnormality, either past or present, that in the investigator's judgment may interfere with the evaluation of safety or efficacy, prevent full participation in the study, or make participation not in the subject's best interest.","ALL","18 Years","80 Years",{"count":20,"type":21},54,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study aims to evaluate the efficacy and safety of JSKN016 combined with toripalimab and carboplatin as a neoadjuvant treatment regimen in patients with resectable stage II-III NSCLC.",[27],"NSCLC Stage II","NOT_YET_RECRUITING","2026-03-20",{"date":31,"type":32},"2026-03-27","ACTUAL",{"date":34,"type":21},"2026-03",{"date":36,"type":21},"2029-01-01",{"name":38,"class":39},"Shanghai Pulmonary Hospital, Shanghai, China","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":60,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100617831","phase-2-a-study-of-bio-300-and-thoracic-radiation-therapy-in-people-with-non-small-cell-lung-cancer-and-interstitial-lung-disease-100617831","NCT07323732","A Study of BIO 300 and Thoracic Radiation Therapy in People With Non-Small Cell Lung Cancer and Interstitial Lung Disease","A Phase II Study of BIO 300 to Reduce the Toxicity of Thoracic Radiotherapy for Patients With Early-Stage Non-Small Cell Lung Cancer and Interstitial Lung Disease (BREATHE)","Inclusion Criteria:\n\n* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. - Patient age ≥ 18 at time of consent\n* Stage I - II NSCLC (as per the American Joint Commission on Cancer (AJCC) 8th edition)\n\n  ° Pathologically proven diagnosis of cancer is strongly recommended but is not required if the risk of biopsy is unacceptable. If pathological evidence is not available, there must be clinical evidence for NSCLC and multidisciplinary consensus for treatment.\n* Interstitial Lung Disease diagnosis (one of the below)\n\n  * ILD as diagnosed and managed by a pulmonologist\n  * ILD based on diagnostic imaging criteria and abnormal DLCO\n  * ILD as a result of connective tissue diseases (e.g., polymyositis\u002Fdermatomyositis, rheumatoid arthritis, systemic lupus erythematosus, Sjogren's syndrome, scleroderma, mixed connective tissue disease)\n* ECOG performance status of 0 - 3\n* Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrhoeic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\n  * Women \\\u003C50 years of age would be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).\n  * Women ≥50 years of age would be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \\>1 year ago, had chemotherapy-induced menopause with last menses \\>1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).\n* Life expectancy of at least 6 months\n\nExclusion Criteria:\n\n* Previous thoracic radiation\n* History of pneumonectomy\n* Major surgical procedure (e.g. intra-cranial, intra-thoracic, intra-abdominal, or intra-pelvic) within 28 days prior to enrollment.\n* Severe concurrent illness that may preclude timely completion of thoracic radiation or study procedures\n* Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n* ILD exacerbation requiring hospitalization in the last 30 days\n* Poorly controlled cardiac arrhythmias not responding to medical therapy or a pacemaker\n* Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential unless they are willing to employ a highly effective non-estrogen based contraception from screening to 30 days after the last dose of BIO 300 or to abstain from sexual intercourse during these time periods.\n\n  1. Effective method of non-estrogen-based contraception: condom and a diaphragm, condom and intrauterine device, condom and Depo-Provera, condom and Nexplanon, or condom and progesterone mini-pill\n  2. Women who have been off estrogen contraceptives for a minimum 5 days prior to the first scheduled day of study intervention dosing are eligible.\n* Concomitant medications:\n\n  1. Any investigational anticancer therapy.\n  2. Planned concurrent chemotherapy or immunotherapy\n  3. Biologic drugs targeting the immune system (e.g. TNFα blockers, anakinra, rituximab, abatacept, tocilizumab) planned to be use concurrently with BIO 300",{"count":49,"type":21},25,[24],"The purpose of this study to find out whether giving BIO 300 in combination with thoracic radiation therapy is effective in preventing pneumonitis in people with non-small cell lung cancer (NSCLC) and interstitial lung disease (ILD).",[53,54,27,55,56,57,58,59],"NSCLC","NSCLC, Stage I","Non Small Cell Lung Cancer","Non-small Cell Lung Cancer Stage I","Non-small Cell Lung Cancer Stage II","Interstitial Lung Disease","Interstitial Lung Disease Due to Connective Tissue Disease (Disorder)",[55,61,62,53,63,27,58,59,64,65],"Non Small Cell Lung Cancer Stage I","Non Small Cell Lung Cancer Stage II","NSCLC Stage I","Memorial Sloan Kettering Cancer Center","25-310","RECRUITING","2026-03-02",{"date":69,"type":32},"2026-03-03",{"date":71,"type":32},"2026-01-06",{"date":73,"type":21},"2029-01-06",{"name":64,"class":39},7,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":40},"100624541","phase-2-efficacy-of-anti-ctla-4-antibody-combined-with-sintilimab-and-chemotherapy-as-neoadjuvant-therapy-for-resectable-stage-ii-iii-non-small-cell-lung-cancer-100624541","NCT07410975","Efficacy of Anti-CTLA-4 Antibody Combined With Sintilimab and Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-III Non-Small Cell Lung Cancer","Efficacy of Anti-CTLA-4 Antibody Combined With Sintilimab and Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-III Non-Small Cell Lung Cancer: A Phase II, Single-Arm Clinical Study","INCLUSION CRITERIA\n\n1. The patient shall sign the informed consent.\n2. Age ≥ 18 years.\n3. Histologically or cytologically confirmed non-small-cell lung cancer (NSCLC).\n4. No prior anticancer therapy, including (but not limited to) chemotherapy, immunotherapy or radiotherapy. Traditional Chinese medicine given for anticancer intent is permitted provided it was discontinued ≥ 2 weeks before first dose.\n5. Investigator-assessed resectable Stage II-IIIB (N3 excluded) NSCLC per AJCC 9th.\n6. Non-squamous NSCLC: no EGFR mutation, ALK rearrangement or any other driver mutation with an approved targeted agent. Squamous NSCLC: no known EGFR mutation, ALK rearrangement or other actionable driver mutation.\n7. PD-L1 expression negative (22C3 or E1L3N).\n8. ECOG performance status 0 or 1.\n9. Adequate organ function within 7 days before first dose:\n\n   * Haemoglobin ≥ 90 g\u002FL (no transfusion within 28 days)\n   * Absolute neutrophil count ≥ 1.5 × 10⁹\u002FL\n   * Platelet count ≥ 100 × 10⁹\u002FL (no platelet transfusion or IL-11 within 14 days)\n   * Creatinine clearance ≥ 60 mL\u002Fmin (Cockcroft-Gault)\n   * Total bilirubin ≤ 1.5 × ULN (≤ 2.5 × ULN in Gilbert's syndrome or hepatic metastases)\n   * ALT and AST ≤ 3 × ULN\n   * INR or aPTT ≤ 1.5 × ULN\n   * FEV\\> 2L, FEV1\\> 1L, FEV1\u002FFVC ≥ 70%, DLCO ≥ 70% predicted; or Investigator determination that pulmonary reserve is adequate for planned surgery.\n10. Fertile female must have a negative serum pregnancy test within 7 days before first dose.\n11. Fertile female and male patients with female partners of childbearing potential must use a highly effective contraceptive method (annual failure rate \\\u003C 1 %) from 7 days before first dose until 24 weeks after the last dose.\n\nEXCLUSION CRITERIA\n\n1. Major thoracic or abdominal surgery within 28 days before first dose or incomplete recovery from previous surgery.\n2. Participants who were systemically treated with corticosteroids (prednisone or other corticosteroids \\>10 mg\u002Fday) or other immunosuppressive agents for ≥ 7 consecutive days within 14 days before first dose. Except for inhaled or topical corticosteroids, or corticosteroid therapy at physiological replacement doses for adrenal insufficiency; short- courses (\\\u003C7 days) corticosteroid use is permitted for the prevention or treatment of non-autoimmune conditions;\n3. Participants who received live vaccines (including live attenuated vaccines) within 28 days before first dose.\n4. Current or prior interstitial pneumonia or pulmonary diseases requiring systemic glucocorticoids.\n5. Presence of any active autoimmune disease or history of autoimmune disease. Except in the following cases: Type 1 diabetes, stable hypothyroidism under hormone replacement therapy, psoriasis or vitiligo not requiring systemic treatment.\n6. Other malignancy within 5 years before first dose, except for tumors assessed by the investigator as cured.\n7. Uncontrolled comorbidities, including:\n\n   * Active hepatitis B (HBsAg positive and HBV DNA \\> 500 IU\u002FmL or \\> 2000 copies\u002FmL) or hepatitis C (HCV antibody and HCV RNA positive). Subjects with HBV DNA ≤ 500 IU\u002FmL who agree to antiviral prophylaxis are eligible.\n   * Known HIV infection or history of AIDS.\n   * Active tuberculosis.\n   * Active infection requiring systemic antibiotics for \\> 7 days within 28 days before first dose.\n   * Clinically significant cardiovascular disease: cerebrovascular accident within 6 months, symptomatic heart failure (NYHA class II-IV), unstable angina or myocardial infarction within 6 months, risk of QTc prolongation or arrhythmia.\n   * Urine protein qualitative≥ 2+, and 24-hour urine protein test \\> 1g\n8. History of allogeneic haematopoietic stem-cell or solid-organ transplantation.\n9. Hypersensitivity to antibody therapies (≥ grade 3 NCI-CTCAE v6.0), history of anaphylaxis, uncontrolled asthma, or significant drug allergies.\n10. Pregnancy or lactation.\n11. Other conditions that may affect the safety or compliance of drug therapy in this study include, but are not limited to, psychiatric disorders, uncontrolled large serosal cavity effusions, or moderate to large serosal cavity effusions requiring repeated drainage (recurring within 2 weeks after intervention), such as pleural effusion, pericardial effusion, or ascites cachexia.",{"count":20,"type":21},[24],"This study aims to evaluate the major pathologic response (MPR) rate of neoadjuvant therapy with sintilimab (PD-1 inhibitor) + IBI310 (anti-CTLA-4 antibody) + chemotherapy, and to assess the efficacy of this treatment strategy in patients with PD-L1-negative stage II - IIIB (excluding N3) NSCLC (according to AJCC 9th) scheduled for surgery.",[27,87],"NSCLC Stage III",[89,53,90],"CTLA-4","neoadjuvant","2026-02-06",{"date":93,"type":32},"2026-02-13",{"date":95,"type":32},"2026-01-10",{"date":97,"type":21},"2030-01-10",{"name":38,"class":39},{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":108,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":122},"100588752","pilot-for-the-precision-exercise-regimen-for-cancer-care-percc-study-100588752","NCT06945484","PILOT for The Precision Exercise Regimen for Cancer Care (PERCC) Study","PILOT PERCC","Inclusion Criteria:\n\n* Ages 18 and older at time of diagnosis\n* Patient diagnosed with stage II and III non-small cell lung cancer (NSCLC)\n* Patient receives either neoadjuvant chemotherapy or immunotherapy and surgery\n* Patient able to follow direction and complete questionnaires in English or Spanish\n* Patient agrees to complete the PERCC intervention\n\nExclusion Criteria:\n\n* Morbidly obese (BMI \\>40 kg\u002Fm2 ) or anorexic (BMI \\\u003C17.5 kg\u002Fm2 )\n* Abnormalities on screening physical exam per study physicians or physical therapist to contraindicate participation in exercise program compliance\n* Alcohol or drug abuse, significant mental or emotional problems that would interfere with compliance (assessed by NCCN Distress Thermometer)\n* Patient scheduled to receive single modality cancer treatment (unimodal therapy), scheduled to begin treatment within 2 weeks of the pre-treatment clinic visit, or for whom treatment has already started",{"count":107,"type":21},20,[109],"NA","This study is designed to evaluate whether a precision exercise regimen is feasible to implement within cancer populations, specifically stage II-III primary lung cancer patients receiving multimodal therapy, and delivered through telehealth.",[27,112],"NSCLC, Stage III","2026-01-30",{"date":115,"type":32},"2026-02-03",{"date":117,"type":32},"2025-11-21",{"date":119,"type":21},"2030-12",{"name":121,"class":39},"University of Utah",2,{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":130,"targetDuration":4,"studyType":132,"phases":4,"briefSummary":133,"conditions":134,"keywords":136,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":4},"100581937","construction-of-a-prognostic-and-prediction-model-for-perioperative-immunotherapy-in-nsclc-a-multi---omics-perspective-100581937","NCT06856798","Construction of a Prognostic and Prediction Model for Perioperative Immunotherapy in NSCLC: A Multi - Omics Perspective","Construction of a Efficacy Stratification Prognostic and Prediction Model for Perioperative Immunotherapy in Non - Small Cell Lung Cancer Based on Multi - Omics Biomarkers","Inclusion Criteria:\n\n* NSCLC, clinical tumor stage II-IIIB\n* Without EGFR\u002FALK gene mutation\n* Patient 18 years or older.\n* Scheduled for neoadjuvant immunotherapy.\n* Eastern Cooperative Oncology Group (ECOG) performance status score 0-1\n* Life expectancy ≥ 12 weeks.\n* Patient able to understand and sign written informed consent.\n\nExclusion Criteria:\n\n* With other cancers (excluding NSCLC or skin cancer other than melanoma, or cancers treated curatively with follow up of more than 5 years without recurrence).\n* With history of chemotherapy or radiotherapy (including pre - operative and post - operative adjuvant chemotherapy and radiotherapy) or systemic anti - tumor treatment.\n* with autoimmune diseases unsuitable for PD - 1 monoclonal antibody treatment, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain - Barré syndrome, or multiple sclerosis.\n* Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude), inability to return for subsequent visits) and\u002For otherwise considered by the Investigator to be unlikely to complete the study.",{"count":131,"type":21},120,"OBSERVATIONAL","This research focuses on exploring biomarkers for the application of PD - 1\u002FPD - L1 immune checkpoint inhibitors in the perioperative immunotherapy of lung cancer. Multi - index tests are conducted on tissues prior to treatment, as well as blood samples at baseline and during the treatment course. The goal is to identify biomarkers capable of predicting the efficacy of neoadjuvant and adjuvant immunotherapies. Additionally, by integrating these multiple - index data into models, patients are to be stratified based on their potential benefits from perioperative immunotherapy, providing personalized guidance for clinical decision - making.",[135,27],"NSCLC Stage IIIA\u002FB",[137,138,139,140,141],"Multi - Omics Biomarkers","Immunotherapy","Perioperative","ctDNA","MRD","2025-03-02",{"date":144,"type":32},"2025-03-04",{"date":146,"type":21},"2025-03-10",{"date":148,"type":21},"2028-02-09",{"name":150,"class":39},"Ziming Li",{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":22,"phases":160,"briefSummary":161,"conditions":162,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":40},"100428914","phase-2-predicting-response-to-neoadjuvant-atezolizumab-plus-carboplatinnab-paclitaxel-in-resectable-non-squamous-nsclc-100428914","NCT04865250","Predicting Response to Neoadjuvant ATEZOLIZUMAB Plus Carboplatin\u002FNab Paclitaxel in Resectable Non-squamous NSCLC","Exploratory Study Evaluating the Potential of Immune Signature Profiling for Predicting Response in Patients With Resectable Stage II, IIIA and Select IIIB (T3N2 Only) Non-squamous Non-Small Cell Lung Cancer (NSCLC) to Neoadjuvant ATEZOLIZUMAB Plus Carboplatin\u002FNab Paclitaxel","iReP","Inclusion Criteria:\n\n* Informed consent, patients age ≥ 18-year-old including, signed and dated\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Histologically confirmed NSCLC of non-squamous histology, cStage II, IIIA or select IIIB (T3N2 only); for T-status ≤ T3 allowed; for N2 patients only IIIa1-3 Robinson classification allowed\n* Deemed surgically resectable with curative intent by an attending thoracic surgeon after adequate staging including PET-CT (positron emission tomography)\n* Adequate lung and cardiac function for intended lung resection according to German S3 regulation\n* Radiologically measurable disease as defined by response evaluation criteria in solid tumors RECIST v1.1\n* Sufficient availability of the tissue sample from primary tumor before start of neoadjuvant treatment\n* Females of child-bearing potential must agree to use, and be able to comply with, effective contraception (\\\u003C\u002F=1% failure rate annually) without interruption, 28 days prior to starting therapy (including dose interruptions), and while on study medication or for a period of 120 days after the last dose of study medication\n* Females must have a negative serum pregnancy test (β -hCG) result at screening and agree to ongoing pregnancy testing during the course of the study, and after the end of study therapy.\n* Male subjects must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following treatment discontinuation, even if he has undergone a successful vasectomy.\n* adequate renal, hepatic, and bone marrow function as defined below\n\n  * Absolute neutrophil count (ANC) \\> 1500\u002Fμl\n  * Platelet count ≥ 100000\u002Fμl\n  * Hemoglobin ≥ 9 g\u002Fdl (can be post-transfusion)\n  * International normalized ratio (INR) ≤ 1.4 in patients not receiving anticoagulation; for patients receiving respective anticoagulation an INR ≤3.0 allowed\n  * Activated partial thromboplastin time (aPTT) ≤ 1.5 times upper limit of normal (ULN) in patients not receiving anticoagulation; for patients receiving respective anticoagulation a PTT ≤2.5 ULN allowed\n  * Bilirubin \\\u003C 1.5 times ULN (for patients with known Gilbert disease Bilirubin ≤ 3 times ULN allowed)\n  * ALT and AST \\\u003C 2.5 times ULN\n  * Creatinine ≤ 1.5 ULN or calculated creatinine clearance \\> 60 ml\u002Fmin for subjects with creatinine levels \\> 1.5 ULN; for patients meeting the criterion of creatinine ≤ 1.5 ULN also a calculated creatinine clearance of \\> 30 ml\u002Fmin is mandatory\n\nExclusion Criteria:\n\n* Illness or condition that may interfere with a patient's capacity to understand, follow, and\u002For comply with study procedures\n* Treatment in any other clinical trial within 30 days before screening.\n* NSCLC Stage cT4\n* NSCLC stage cN3 or cN2 IIIA4 (bulky or fixed multi-station N2 disease) according to Robinson classification\n* NSCLC of squamous cell histology\n* Any prior therapy for lung cancer (including systemic therapy, radiotherapy or major surgery)\n* Malignancies other than NSCLC within 5 years prior to study inclusion with the exception of malignancies with a negligible risk of metastasis or death (5-year OS \\> 90%) like localized prostate cancer, ductal carcinoma in situ, adequately treated carcinoma in situ of the cervix, Stage I uterine cancer or non-melanoma skin carcinoma\n* History of allogeneic tissue \u002F solid organ transplant or allogeneic stem cell transplantation\n* Patients with active hepatitis B or C infections or a history of HIV infection\n* Pregnant or lactating women\n* Active autoimmune disease or history of severe autoimmune disease or immunodeficiency or a syndrome that requires systemic steroids or immunosuppressive agents\n* The following exceptions are granted:\n\n  * patients with vitiligo, eczema, lichen simplex or resolved childhood asthma\u002Fatopy\n  * subjects requiring intermittent use of bronchodilatators or local steroid injections\n  * patients with hypothyroidism stable on hormone replacement\n* Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, and anti-tumor necrosis factor (anti-TNF) agents) within 2 weeks prior to Cycle 1, Day 1 (except low-dose steroids for adrenal failure or emesis prophylaxis)\n* History of idiopathic pulmonary fibrosis, interstitial lung disease, organizing pneumonia, drug-induced pneumonitis, or evidence of active pneumonitis on screening chest Computed Tomography (CT) scan\n* Prior treatment with cluster of differentiation 137 (CD137) agonist or immune checkpoint blockade therapies, anti-programmed-death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibody\n* Live vaccine within 30 days prior to first dose of trial treatment\n* Cerebrovascular accident within the past 6 months\n* Severe infection or significant traumatic injury within the past 4 weeks\n* Clinically significant history of cardiovascular disease, including any of the following:\n\n  * Myocardial infarction or unstable angina within the past 6 months\n  * New York Heart Association class II, III-IV congestive heart failure\n  * Poorly controlled cardiac arrhythmia despite medication, except rate-controlled atrial fibrillation\n* Known allergy or hypersensitivity to any component of the chemotherapy regimen Patients who have been incarcerated or involuntarily institutionalized by court order or by the authorities, as well as patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial",{"count":107,"type":21},[24],"Exploratory study evaluating the potential of immune signature profiling for predicting response in patients with resectable Stage II, IIIA and select IIIB (T3N2 only) non-squamous Non-Small Cell Lung Cancer (NSCLC) to neoadjuvant ATEZOLIZUMAB plus Carboplatin\u002Fnab Paclitaxel\n\nAtezolizumab is given as intravenous infusion at a fixed dose of 1200 mg, day 1 of each 21-day cycle (every 3 weeks) for 3 cycles during the neoadjuvant treatment phase, Carboplatin at an initial dose of AUC (area under curve) 5 mg\u002FmL\u002Fmin, intravenously day 1 of each 21-day cycle for 3 cycles during the neoadjuvant treatment Phase, and Nab-Paclitaxel (Abraxane) at 100 mg\u002Fm2, intravenously day 1, 8 and 15 of each 21-day cycle for 3 cycles during the neoadjuvant treatment phase. Surgery after the 3rd cycle Atezolizumab \u002F Carboplatin \u002F Nab-Paclitaxel is standard procedure.",[27,163,164],"NSCLC, Stage IIIA","NSCLC Stage IIIB","2024-05-13",{"date":167,"type":32},"2024-05-16",{"date":169,"type":32},"2021-01-07",{"date":171,"type":21},"2026-12-30",{"name":173,"class":39},"University Hospital Heidelberg"]