[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-small-cell-lung-cancer-stage-iii\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-small-cell-lung-cancer-stage-iii":533},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,43,69,136,164,187,210,236,259,285,307,331,353,374,401,425,453,474,503],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100550610","phase-2-neoadjuvant-chemo-immunotherapy-and-surgical-resection-in-locally-advanced-non-small-cell-lung-cancer-with-n3-lymph-node-involvement-100550610",false,"NCT06449313","Neoadjuvant Chemo-Immunotherapy and Surgical Resection in Locally Advanced Non-small Cell Lung Cancer With N3 Lymph Node Involvement","A Phase 2 Single-Arm Study of Neoadjuvant Chemo-Immunotherapy and Surgical Resection in Locally Advance Non-Small Cell Lung Cancer (NSCLC) With N3 Lymph Node Involvement","NEO-SURG","Inclusion Criteria:\n\n1. Age ≥ 18 years at time of signing the informed consent form (ICF).\n2. Histologically or cytologically confirmed stage 3 B\u002FC Non-Small Cell Lung Cancer (NSCLC) as assessed per the 8th American Joint Committee on Cancer (AJCC) with pathologically-confirmed contralateral mediastinal or ipsilateral supraclavicular (N3) lymph node involvement.\n3. Primary tumor appropriate for resection with curative intent as assessed by the treating surgeon prior to study enrollment.\n4. Absence of major associated pathologies and co-morbidities that elevate surgery risk to a prohibitive level, as assessed by treating surgeon prior to study enrollment.\n5. Pulmonary function capacity capable of tolerating the lung resection proposed by the treating surgeon.\n6. EGFR, ALK, wild-type assessed via any CLIA-certified tissue testing platform. Documentation of EGFR and ALK status is not required for pure squamous NSCLC histology.\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.\n8. Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 21 days prior to initiation of study treatment:\n\n   1. Absolute Neutrophil count (ANC) ≥ 1.0 x 10\\^9\u002FL (1000\u002FuL) without granulocyte colony-stimulating factor support\n   2. Platelet count ≥ 100 x 10\\^9\u002FL (100,000\u002FuL) without transfusion\n   3. Hemoglobin ≥ 90 g\u002FL (9.0 g\u002FdL) (Patients may be transfused to meet this criterion.)\n   4. Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) \\\u003C\u002F= 3 x upper limit of normal (ULN)\n   5. Serum bilirubin \\\u003C\u002F= 2.0 x ULN with the following exception: Patients with known Gilbert disease: serum bilirubin \\\u003C\u002F= 3 x ULN\n   6. Creatinine clearance ≥ 45 mL\u002Fmin (calculated using the Cockcroft-Gault formula). If creatinine clearance determined by Cockcroft-Gault is \\\u003C45 mL\u002Fmin, another appropriate validated formula or 24hr urine collection may be used in consultation with the study PI.\n   7. For patients not receiving therapeutic anticoagulation: INR (international normalised ratio) and aPTT (activated partial thromboplastin time) \\\u003C\u002F= 1.5 x ULN. For patients receiving therapeutic anticoagulation: stable anticoagulant regimen defined as clinical stability on unchanged dose of therapeutic anticoagulation for ≥14 days.\n9. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs, as defined below:\n\n   Women must remain abstinent or use highly effective contraceptive methods with a failure rate of \\\u003C 1% per year during the treatment period and for at least 4 months after the final dose of study treatment. Women must refrain from donating eggs during this same period.\n\n   A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements.\n\n   Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n\n   The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception.\n10. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:\n\nWith a female partner of childbearing potential who is not pregnant, or a female partner who is pregnant, men who are not surgically sterile must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C 1% per year during the treatment period and for 4 months after the final dose of study treatment. Men must refrain from donating sperm during this this same period.\n\nThe reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception.\n\nExclusion Criteria:\n\n1. NSCLC with histology containing any of the following: large cell neuroendocrine carcinoma, small cell lung cancer.\n2. Primary tumor not deemed appropriate for surgical resection as assessed by treating surgeon.\n\n   1. Tumor with direct invasion of: mediastinum, diaphragm, heart, great vessels, trachea, esophagus, vertebral body, or carina.\n   2. Any other tumor characteristic making it not suitable for resection as determined by treating surgeon.\n3. Any prior systemic therapy for index lung cancer, including immunotherapy, chemotherapy.\n4. History of malignancy requiring systemic therapy within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death as assessed and confirmed by the study PI. (Patients with a history of stage I NSCLC treated with resection or radiotherapy are eligible for inclusion.)\n5. Active or history of clinically significant autoimmune disease that, in the opinion of the investigator, could compromise the health and safety of the patient if treated with anti-PD1 immunotherapy. Notable exceptions include:\n\n   1. Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone.\n   2. Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen.\n   3. Active or history of adrenal insufficiency on stable steroid regimen.\n   4. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only are eligible for the study provided all of following conditions are met: Disease is well controlled at baseline and requires only low-potency topical corticosteroids; No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency oral corticosteroids within the previous 12 months\n6. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.\n7. Known active tuberculosis.\n8. Known history of poorly controlled HIV. Patients living with HIV are allowed to enroll if: (1) they are clinically stable on appropriate highly active anti-retroviral therapy (HAART) with undetectable HIV viral load and CD4 count \\>350 and (2) the HAART regimen poses no unacceptable interactions with the prescribed anti-cancer therapies.\n9. Known history of poorly controlled hepatitis B or hepatitis C\n\n   1. Patients with known hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus (HBV) DNA PCR that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA per local standards and must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study drug.\n   2. Patients who are known hepatitis C virus (HCV) antibody positive (HCV Ab+) who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted.\n10. Severe infection within 3 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection (including COVID-19), bacteremia, or severe pneumonia that, in the opinion of the investigator, may impact patient safety.\n11. Prior allogeneic stem cell or solid organ transplantation.\n12. Any treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during study treatment or within 5 months after the final dose of study treatment.\n13. Significant vascular and cardiovascular disease (e.g., New York Heart Association Class II or greater heart failure, unstable arrhythmia, aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis - including but not limited to myocardial infarction, transient ischemic attack, stroke or unstable angina) within 6 months prior to study treatment initiation.\n14. Treatment with systemic immunosuppressive medication (including, but not limited to: corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-alpha agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:\n\n    1. Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study after PI confirmation has been obtained.\n    2. Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.\n15. Any prior use of an immune checkpoint blockade therapy including agents directed against CTLA-4, PD-1, and PD-L1.\n16. History of severe allergic reaction or hypersensitivity to study drug components.\n17. Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 6 months after the final dose of study treatment. Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment.","ALL","18 Years",{"count":20,"type":21},21,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this clinical trial is to learn about neoadjuvant cemiplimab with histology-specific chemotherapy followed by resection and adjuvant cemiplimab in stage 3 non-small cell lung cancer (NSCLC) with contralateral mediastinal or ipsilateral supraclavicular lymph node (N3) involvement..\n\nThe main question it aims to answer is whether patients with stage 3 NSCLC with involvement of lymph nodes can undergo surgery to remove the cancer after receiving treatment with chemotherapy + immunotherapy.\n\nParticipants will receive FDA-approved chemotherapy called platinum-doublet chemotherapy together with an immunotherapy drug targeting the immune marker PD-1 called cemiplimab. Patients will receive a 3 drug combination for 4 total treatments given every 3 weeks before surgery. After surgery, patients will have the option to undergo radiation therapy if it is recommended by their treatment team. After this, they will receive cemiplimab every 3 weeks for one year.",[27],"Non-small Cell Lung Cancer Stage III",[29],"non-small cell lung cancer","RECRUITING","2026-06-08",{"date":33,"type":34},"2026-06-10","ACTUAL",{"date":36,"type":21},"2026-08",{"date":38,"type":21},"2032-09",{"name":40,"class":41},"Georgetown University","OTHER",3,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":68},"100642227","phase-3-a-study-comparing-bl-b01d1-in-combination-with-osimertinib-versus-osimertinib-alone-in-patients-with-locally-advanced-unresectable-egfr-mutated-non-small-cell-lung-cancerstage-iii-whose-disease-has-not-progressed-following-definitive-platinum-based-chemoradiation-therapypanku-lung08-100642227","NCT07640789","A Study Comparing BL-B01D1 in Combination With Osimertinib Versus Osimertinib Alone in Patients With Locally Advanced, Unresectable EGFR-mutated Non-small Cell Lung Cancer(Stage III) Whose Disease Has Not Progressed Following Definitive Platinum-based Chemoradiation Therapy(PANKU-Lung08)","A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 in Combination With Osimertinib Versus Osimertinib Alone in Patients With Locally Advanced, Unresectable EGFR-mutated Non-small Cell Lung Cancer(Stage III) Whose Disease Has Not Progressed Following Definitive Platinum-based Chemoradiation Therapy(PANKU-Lung08)","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. Age ≥ 18 years and ≤ 75 years, regardless of gender;\n3. Expected survival time ≥ 3 months;\n4. Unresectable Stage III non-small cell lung cancer;\n5. Detection of one of the EGFR-sensitive mutation types in tumor tissue;\n6. Agree to provide archived primary tumor tissue specimens or fresh tissue samples within 1 year;\n7. In platinum-based radical chemoradiotherapy, the platinum-containing chemotherapy regimen must include one of the specified drugs in addition to the platinum agent;\n8. In platinum-based radical chemoradiotherapy, patients must have received a total radiation dose of 60 Gy ± 10% before randomization;\n9. Toxicities from prior chemoradiotherapy must have resolved to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n10. ECOG performance status score of 0 or 1;\n11. No severe cardiac dysfunction, with left ventricular ejection fraction ≥ 50%;\n12. Organ function levels must meet the requirements;\n13. Urine protein ≤ 1+ or \\\u003C 1000 mg\u002F24h;\n14. For premenopausal women with childbearing potential, a serum pregnancy test must be performed within 7 days before starting treatment, and the test must rule out pregnancy; they must not be lactating; all enrolled trial participants must take adequate barrier contraceptive measures throughout the treatment period and for 7 months after treatment ends.\n\nExclusion Criteria:\n\n1. SCLC, mixed SCLC and NSCLC, or other non-NSCLC pathological types;\n2. The trial participant has received other chemotherapy, radiotherapy, etc., for NSCLC apart from radical chemoradiotherapy;\n3. Major surgery within 4 weeks prior to the first dose;\n4. Prior treatment with ADC drugs using topoisomerase I inhibitors as toxins, or antibodies\u002FADCs targeting EGFR and\u002For HER3;\n5. History of severe heart disease or cerebrovascular disease;\n6. Prolonged QTc interval, complete left bundle branch block, second- or third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;\n7. Any thrombotic events such as deep vein thrombosis, arterial thrombosis, or pulmonary embolism within 6 months prior to screening;\n8. Diagnosis of active malignancy within 5 years prior to study randomization;\n9. Hypertension poorly controlled by two antihypertensive medications;\n10. Trial participants with poorly controlled blood glucose levels;\n11. Current radiation pneumonitis of Grade ≥2 as defined by CTCAE;\n12. Concurrent lung disease resulting in clinically severe respiratory impairment;\n13. Severe infection within 4 weeks prior to study randomization;\n14. Large serous cavity effusions or symptomatic serous cavity effusions;\n15. Imaging findings suggesting tumor invasion or encasement of major blood vessels in the abdomen, chest, neck, or pharynx;\n16. Severe non-healing wounds, ulcers, or fractures within 4 weeks prior to signing informed consent;\n17. Trial participants with clinically significant bleeding or a clear tendency for bleeding within 4 weeks prior to signing informed consent;\n18. Trial participants with a history of inflammatory bowel disease, extensive bowel resection, or immune-mediated enteritis;\n19. History of allergy to recombinant humanized antibodies or chimeric human-mouse antibodies, or allergy to any excipient components of the investigational drug;\n20. History of autologous or allogeneic stem cell transplantation;\n21. Positive for human immunodeficiency virus antibodies, active hepatitis B virus infection, or hepatitis C virus infection;\n22. History of severe neurological or psychiatric disorders, or a history of substance abuse, alcoholism, or drug addiction;\n23. Trial participants planning to receive or having received live vaccines within 28 days prior to study randomization;\n24. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial due to complications or other reasons.","75 Years",{"count":52,"type":21},418,[54],"PHASE3","This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in combination with osimertinib in patients with unresectable EGFR-mutated Stage III non-small cell lung cancer who have not progressed following platinum-based chemoradiotherapy.",[27],"NOT_YET_RECRUITING","2026-06-07",{"date":60,"type":34},"2026-06-11",{"date":62,"type":21},"2026-06",{"date":64,"type":21},"2030-12",{"name":66,"class":67},"Sichuan Baili Pharmaceutical Co., Ltd.","INDUSTRY",1,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":89,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":135},"100551713","phase-2-efficacy--safety-of-olvimulogene-nanivacirepvec--platinum-doublet--physicians-choice-of-immune-checkpoint-inhibitor-compared-to-docetaxel-in-nscl-cancer-100551713","NCT06463665","Efficacy & Safety of Olvimulogene Nanivacirepvec & Platinum-doublet + Physician's Choice of Immune Checkpoint Inhibitor Compared to Docetaxel in NSCL Cancer","A Randomized Phase 2 Study Assessing the Efficacy and Safety of Olvimulogene Nanivacirepvec Followed by Platinum-doublet Chemotherapy + Physician's Choice of Immune Checkpoint Inhibitor Compared With Docetaxel in Patients With NSCL Cancer After First Progression While on Front-line Immune Checkpoint Inhibitor-based Maintenance","VIRO-25","Inclusion Criteria:\n\n* Male or female 18 years or older.\n* ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.\n* Have histologically or cytologically confirmed advanced or metastatic NSCLC.\n* Histologically confirmed Stage III or IV squamous or nonsquamous \\[American Joint Committee on Cancer (AJCC) 8th edition\\].\n* Received at least 2 cycles and maximum of 6 cycles of front-line platinum-based chemotherapy with ICI-based therapy, regardless of PD-L1 expression.\n* Reached first disease progression by radiological assessment while receiving front-line or maintenance ICI.\n* At least one measurable target tumor lesion anywhere except the brain per RECIST 1.1 by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scan.\n* Have adequate renal, hepatic, bone marrow function as well as adequate coagulation tests \\[International Normalized Ratio (INR)\\] and adequate immune function by lymphocyte count.\n* Women of child-bearing potential must have a negative serum pregnancy test prior to initiating study dosing.\n* Be willing and able to comply with scheduled visits, the treatment plan, imaging and laboratory tests.\n\nExclusion Criteria:\n\n* Active and untreated urinary tract infection, pneumonia, or other systemic infections.\n* Current symptomatic central nervous system (CNS) metastasis.\n* Any uncontrolled systemic disease, condition or comorbidity that, in the opinion of the Investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results.\n* Persistent toxicities \\[Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 3\\] caused by previous anticancer therapy; alopecia and vitiligo are excluded toxicities.\n* Required the use of additional immunosuppression other than corticosteroids for the management of an adverse event or have experienced recurrence of an adverse event if re-challenged, or currently require maintenance doses of \\>10 mg prednisone or equivalent per day.\n* Receiving concurrent antiviral agent active against vaccinia virus (e.g., cidofovir, vaccinia immunoglobulin, imatinib, tecovirimat, or other agents with known anti-vaccinia activities).\n* Underwent major surgery within 4 weeks, or have insufficient recovery from surgical-related trauma or wound healing, prior to the planned first dose of treatment in either Arm.\n* Have received prior virus-based gene therapy or therapy with cytolytic virus of any type.\n* Vaccination against smallpox or monkeypox within 1 year of study therapy.\n* Any non-oncology vaccine therapy used for prevention of infectious diseases, such as seasonal (influenza) vaccinations, corona virus disease (COVID) vaccination or other vaccines, within 2 weeks of the planned first dose of study drug.\n* Clinically significant skin disease as assessed by the Investigator (e.g., severe eczema, psoriasis, or any unresolved skin injury or ulcer).\n* Known hypersensitivity to carboplatin, cisplatin, paclitaxel or nab-paclitaxel, docetaxel, or any of the constituents of Olvi-Vec (i.e., gentamicin).\n* Had severe hypersensitivity (CTCAE Grade ≥ 3) to ICI and\u002For any of its excipients previously.\n* Dementia or altered mental status that would prohibit informed consent, and\u002For psychiatric illness\u002Fsocial situations that might interfere or limit compliance with study requirements.",{"count":78,"type":21},142,[24],"This Phase 2, open-label, randomized study in non-small-cell lung cancer (NSCLC) is designed to evaluate the efficacy and safety of an intravenously delivered oncolytic vaccinia virus, Olvi-Vec, followed by platinum-doublet chemotherapy + Physician's Choice of Immune Checkpoint Inhibitor (ICI) vs. docetaxel for patients with advanced or metastatic NSCLC who have shown first disease progression (i.e., progressive disease not yet confirmed by further scan after initial scan showing progression) while on front-line treatment or maintenance ICI therapy after front-line treatment with platinum-doublet chemotherapy + ICI as standard of care.",[82,83,84,85,86,27,87,88],"Advanced Non-squamous Non-small-cell Lung Cancer","Advanced Squamous Non-Small Cell Lung Carcinoma","Metastatic Non-squamous Non Small Cell Lung Cancer","Metastatic Squamous Non-Small Cell Lung Carcinoma","Non-small Cell Lung Cancer","Non-small Cell Lung Cancer Stage IV","Non-small Cell Lung Cancer Recurrent",[90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125],"Olvi-Vec","virotherapy","viral therapy","immunotherapy","immunochemotherapy","combination therapy","vaccinia virus","platinum-doublet chemotherapy","pembrolizumab","nivolumab","cemiplimab","atezolizumab","durvalumab","anti-PD-1","anti-PD-L1","carboplatin","cisplatin","docetaxel","neoplasms by site","neoplasms","carcinoma","Neoplasms by Histologic type","Antineoplastic Agents, Phytogenic","Antineoplastic Agents","Antimitotic Agents","Molecular Mechanisms of Pharmacological Action","Immune Checkpoint Inhibitors","NSCLC","NSCL cancer","chemoimmunotherapy","ICI","platinum resensitization","platinum resistant","chemoresistance","resensitize","olvimulogene nanivacirepvec","2026-06-02",{"date":128,"type":34},"2026-06-04",{"date":130,"type":34},"2024-09-26",{"date":132,"type":21},"2029-07",{"name":134,"class":67},"Genelux Corporation",15,{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":22,"phases":145,"briefSummary":146,"conditions":147,"keywords":149,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":163},"100469844","phase-2-clinical-trial-of-amg510-in-stage-iii-unresectable-nsclc-kras-pg12c-patients-and-ineligible-for-chemo-radiotherapy-100469844","NCT05398094","Clinical Trial of AMG510 in Stage III Unresectable NSCLC KRAS p.G12C Patients and Ineligible for Chemo-radiotherapy","Phase II Clinical Trial of AMG510 (Sotorasib) in Stage III Unresectable NSCLC KRAS p.G12C Patients and Medically Ineligible for Concurrent Chemo-radiotherapy","MERIT-lung","Inclusion Criteria:\n\n* 1\\. Male or female, aged ≤ 80 years old\n* 2\\. ECOG performance status of 0-1\n* 3\\. Histologically or cytologically confirmed, unresectable Stage III (IIIA-N2, IIIB and IIIC) NSCLC according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology.\n* 4\\. Patients who have documentation of KRAS p.G12C prior to enrollment. This determination can be done either by solid or liquid biopsy.\n* 5\\. No prior treatment for unresectable Stage III (IIIA-N2, IIIB and IIIC) NSCLC.\n* 6\\. Having a life expectancy ≥ 12 weeks\n* 7\\. Patients must be ineligible for concurrent chemo-radiotherapy because of:\n\n  1. Tumor size ≥ 5 cm and lymph node N2 involvement\n  2. The target lesion has to be bulky disease and\u002For more than 35% of the total volume of the two lungs should receive more than 20 Gy (V20) or inadequate pulmonary function\n  3. Interstitial Lung diseases\n  4. Prior treatment with thoracic radiotherapy for any reason\n  5. Or under decision of a tumor committee as inappropriate due to local characteristics to perform treatment upfront\n* 8\\. PET-CT at baseline is mandatory to confirm the absence of distant disease and to confirm unresectable disease\n* 9\\. PET-CT positive mediastinic adenopathies must be histologically confirmed. Mediastinic involvement could be considered without histological test when no margin can be distinguished in the lymph node mass.\n* 10\\. Brain CT or MRI is mandatory\n* 11\\. Patients with at least 1 measurable lesion, as defined by RECIST v1.1.\n* 12\\. Adequate hematologic and organ function.\n* 13\\. All patients are notified of the investigational nature of this study and signed a written informed consent in accordance with institutional and national guidelines, including the Declaration of Helsinki prior to any trial-related intervention.\n* 14\\. Willingness and ability to comply with scheduled visits and study procedures\n* 15\\. For female patients of childbearing potential, a negative pregnancy test must have been documented prior to enrollment (within 14 days prior to enrollment).\n* 16\\. For female patients of childbearing potential, agreement (by patient and\u002For partner) to usea highly effective form(s) of contraception that results in a low failure rate (\\\u003C 1% per year)when used consistently and correctly, and to continue its use for 7 days after the last dose of AMG510 (Sotorasib). No hormonal methods and preferably barrier method always containing a spermicide, intrauterine device (IUD): intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner (on the understanding that this is the only one partner during the whole study duration), and sexual abstinence.\n* 17\\. For male patients with female partners of childbearing potential, agreement (by patient and\u002For partner) to use a highly effective form(s) of contraception that results in a low failure rate \\[\\\u003C 1% per year\\] when used consistently and correctly, and to continue its use for 7 days after the last dose of AMG510 (Sotorasib).\n* 18\\. Women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to enrollment.\n* 19\\. QTc interval must be ≤ 470 msec in females and ≤ 450 msec in males, based on the average obtained from three ECG.\n\nExclusion Criteria:\n\n* 1\\. Patients with a known sensitizing mutation in the epidermal growth factor receptor (EGFR) gene, ALK translocations or ROS1 mutations\n* 2\\. Weight loss \\>10% within the previous 3 months\n* 3\\. Patients with uncontrolled neuropathy (sensory) grade 2 or greater regardless of cause according to CTCAE v5.0\n* 4\\. Major surgery within 28 days of study day 1\n* 5\\. Significant gastrointestinal disorder that results in significant malabsorption, requirement for intravenous alimentation, or inability to take oral medication\n* 6\\. Significant cardiovascular disease, such as New York Heart Association cardiac disease (ClassII or greater), myocardial infarction within 6 months prior to study day 1, unstable arrhythmias or unstable angina\n* 7\\. Ongoing cardiac dysrhythmias of CTCAE grade ≥2, uncontrolled atrial fibrillation of any grade or QTcF interval \\> 470ms\n* 8\\. Severe infections within 4 weeks prior to randomization including, but not limited to hospitalization for complications of infection, bacteremia or severe pneumonia\n* 9\\. Therapeutic oral or intravenous antibiotics within 2 weeks prior to randomization\n* 10\\. Patients with any concomitant and uncontrolled medical disorder\n* 11\\. Patients with vena cava syndrome\n* 12\\. Malignant pleural or pericardial effusion: both will be considered as suggestive of metastaticdisease. Also, are excluded those with negative cytology but being exudates. Patients with non-visible by thoracic X-ray pleural effusion or too small to be safely punctured could be included.\n* 13\\. Prior treatment with anti-neoplasic drugs\n* 14\\. Malignancies other than NSCLC within 3 years prior to enrollment\n* 15\\. Women who are pregnant, lactating, or intending to become pregnant during the study.\n* 16\\. Positive test for HIV. All patients will be tested for HIV prior to inclusion into the study; patients who test positive for HIV will be excluded from the clinical study.\n* 17\\. Patients with active hepatitis B or hepatitis C.\n* 18\\. Active tuberculosis.\n* 19\\. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications.\n* 20\\. Patients with illnesses or conditions that interfere with their capacity to understand follow and\u002For comply with study procedures.\n* 21\\. Known or suspected hypersensitivity to drugs with similar chemical structures to the study drug\n* 22\\. Evidence of any other disorder or significant laboratory finding that makes the patient undesirable to participate in the study\n* 23\\. Use of strong inducers of CYP3A4 within 14 days of half-lives (whichever is longer) prior to study day 1\n* 24\\. Use of proton pump inhibitors within 14 days to study day",{"count":5,"type":21},[24],"Open-label, non-randomised, exploratory, phase II, multi-centre clinical trial. 43 unresectable stage III (IIIA-N2, IIIB, IIIC) KRAS p.G12C non-small cell lung cancer patients will be enrolled in this trial to evaluate the efficacy of induction treatment of AMG510 (Sotorasib) plus AMG510 (Sotorasib) treatment post-induction as measured by Progression Free Survival at 12 months.",[27,148],"KRAS P.G12C",[150,151,152,153],"Sotorasib","Unresectable","Chemo-radiotherapy","Lung cancer","2026-04-29",{"date":156,"type":34},"2026-04-30",{"date":158,"type":34},"2022-03-21",{"date":160,"type":21},"2028-12-31",{"name":162,"class":41},"Fundación GECP",20,{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":22,"phases":172,"briefSummary":173,"conditions":174,"keywords":176,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":68},"100600987","phase-2-pulmonary-rehabilitation-in-advanced-lung-cancer-survivors-100600987","NCT07104630","Pulmonary Rehabilitation in Advanced Lung Cancer Survivors","Inclusion Criteria:\n\n* Participants must have histologically confirmed NSCLC, Stages III or IV treated with palliative intent\n* Adults ≥ 18 years of age\n* ECOG performance status ≤ 3\n* Clinical stability: defined as no clinical\u002Fradiographic progression within the last three months\n* Self-reported dyspnea, defined as score ≥ 2 on the modified Medical Research Council (mMRC) Dyspnea Scale\n* Participants must be fluent in written and spoken English\n\nExclusion Criteria:\n\n* Participants being treated with curative intent for locally advanced NSCLC or oligometastatic NSCLC with concurrent chemotherapy and radiation will be excluded\n* Participants have evidence of clinical and\u002For radiographic progression\n* Mental impairment leading to inability to complete study requirements\n* High risk of fracture or spine instability (Mirels score ≥7 or SINS ≥7)\n* Any of the following cardiac exclusion criteria:\n\n  * Class II, III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system\n  * History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty or stenting within the past 6 months prior to the start of radiation therapy\n  * Uncontrolled arrhythmias; individuals with rate-controlled atrial fibrillation for \\> 1 month prior to start of radiation therapy may be eligible\n  * Syncope\n  * Acute myocarditis, pericarditis, or endocarditis\n  * Acute pulmonary embolus or pulmonary infarction within the last 3 months\n  * Acute thrombosis of lower extremities within the last 3 months\n  * Suspected dissecting aneurysm\n  * Pulmonary edema\n  * Respiratory failure\n  * Acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise",{"count":171,"type":21},85,[24],"This study is for people who have previously been diagnosed with advanced stage non-small cell lung cancer (NSCLC). Many people with advanced stage NSCLC have trouble breathing and feel tired. People may be eligible for this study if they have advanced stage NSCLC and feel short of breath some of the time. NSCLC survivors may also experience things like fatigue and a lower quality of life. Pulmonary rehabilitation is a type of supportive treatment that may improve these symptoms.\n\nThis study has two parts. The first part is a randomized trial where half of the participants receive eight weeks of pulmonary rehabilitation. The other half of participants do not do pulmonary rehabilitation and instead receive the treatment that their doctors would normally recommend. The purpose of this part of the research study is to understand if pulmonary rehabilitation can help people with advanced stage NSCLC have better functioning and less shortness of breath.\n\nThe other part of the research study is an interview study. The purpose of doing interviews is to understand any challenges or obstacles that people with advanced stage NSCLC may have regarding pulmonary rehabilitation, as well as oncology care providers have with their participants going to pulmonary rehabilitation.",[27,87,86,175],"Lung Cancer",[177],"Pulmonary Rehabilitation","2026-04-09",{"date":180,"type":34},"2026-04-13",{"date":182,"type":34},"2026-03-16",{"date":184,"type":21},"2028-12",{"name":186,"class":41},"Case Comprehensive Cancer Center",{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":194,"enrollmentInfo":195,"targetDuration":4,"studyType":22,"phases":197,"briefSummary":198,"conditions":199,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":68},"100570359","phase-2-efficacy-and-safety-of-sacituzumab-tirumotecan-skb264-in-combination-with-toripalimab-in-patients-with-initially-unresectable-stage-iii-nsclc-100570359","NCT06706219","Efficacy and Safety of Sacituzumab Tirumotecan (SKB264) in Combination With Toripalimab in Patients With Initially Unresectable Stage III NSCLC","Efficacy and Safety of Sacituzumab Tirumotecan (SKB264) in Combination With Toripalimab in Patients With Initially Unresectable Stage III Non-small Cell Lung Cancer (NSCLC): a Phase II Study","Inclusion Criteria:\n\n1. Patients who voluntarily participate in this clinical study, understand the study procedures and are able to sign the informed consent form in writing;\n2. Men or women aged 18-70 years (inclusive) at the time of signing the informed consent form.\n3. ECOG PS score of 0 or 1.\n4. Histologically or cytologically confirmed stage III non-small cell lung cancer that cannot be surgically treated as determined by the investigator. Disease staging should be based on the American Joint Committee on Cancer (AJCC)\u002FUnion for International Cancer Control (UICC) NSCLC staging system, 8th edition.\n5. Ability to provide tumor tissue specimens, either archived within 6 months prior to the first dose of study drug or freshly obtained. See the laboratory manual for specific requirements.\n6. Pulmonary function of at least FEV1 \\> 1.0 L and FEV1% \\> 40% within 3 months.\n7. Patients must have measurable target lesions examined by CT or MRI per RECIST v1.1 criteria. Tumor imaging assessments are performed within 28 days prior to the first dose.\n8. Adequate hematologic and vital organ functions, as defined by the following laboratory findings, which need to be completed within 14 days prior to the first study treatment:\n\n(1). Hematology (no hematopoietic stimulating factor drugs or blood transfusion within 14 days before the first study treatment): absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL, absolute lymphocyte count (LC) ≥ 0.5 × 109\u002FL; platelet count (PLT) ≥ 100 × 109\u002FL, hemoglobin (Hb) ≥ 90 g\u002FL (2). Liver function: aspartate transferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN; ; serum total bilirubin (TBIL) ≤ 1.5 x ULN (total bilirubin ≤ 3.0 mg\u002FdL in patients with confirmed Gilbert syndrome); albumin (ALB) ≥ 3 g\u002FdL; (3). Renal function: creatinine clearance rate (CrCl) ≥ 45 mL\u002Fminute (by Cockcroft-Gault formula); (4). Coagulation: international normalized ratio (INR) ≤ 1.5, activated partial thromboplastin time (APTT) ≤ 1.5 x ULN; (5). Cardiac color ultrasound: left ventricular ejection fraction (LVEF) ≥ 50% 9.Female patients of childbearing potential must have a negative pregnancy test (serum or urine) within 72 hours prior to receiving the study drug. Reliable contraception, such as intrauterine devices, oral contraceptives, or condoms, must be used during the trial and for 90 days following the final dose. Male participants with partners of childbearing potential must use condoms during the trial and for 30 days following the study's conclusion.\n\nExclusion Criteria:\n\n1. Histologically or cytologically confirmed mixed small cell and non-small cell lung cancer, large cell neuroendocrine carcinoma, or sarcomatoid carcinoma.\n2. Patients with EGFR gene mutations or ALK\u002FROS1 gene rearrangements.\n3. Prior systemic anti-tumor therapy for NSCLC (including investigational agents in clinical trials) or prior thoracic radiotherapy.\n4. History of other malignancies within 3 years prior to the first dose, except for those cured by local therapy (e.g., basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, etc.).\n5. Presence of any of the following cardiovascular or cerebrovascular diseases or risk factors: (1) Myocardial infarction, unstable angina, acute or persistent myocardial ischemia, New York Heart Association (NYHA) Class III or IV heart failure, symptomatic or poorly controlled severe arrhythmia, cerebrovascular accident, transient ischemic attack, or other serious cardiovascular or cerebrovascular events occurring within 6 months prior to the first dose; (2) History of myocardial diseases, including myocarditis, primary cardiomyopathy, or specific cardiomyopathy; (3) Any deep vein thrombosis (DVT) within 3 months prior to the first dose (enrollment is permitted if DVT has been stabilized with low molecular weight heparin or equivalent therapy for ≥2 weeks), peripheral arterial thromboembolic events, pulmonary embolism, or other serious thromboembolic events; (4) Presence of aortic aneurysm, aortic dissection, or other major vascular diseases that are potentially life-threatening or requiring surgical intervention within 6 months prior to the first dose\n6. Uncontrolled systemic diseases as judged by the investigator, including but not limited to: (1) Poorly controlled diabetes mellitus (fasting blood glucose ≥10 mmol\u002FL on two consecutive measurements); (2) Poorly controlled hypertension (systolic blood pressure \\>160 mmHg and\u002For diastolic blood pressure \\>100 mmHg).\n7. History of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid therapy; current ILD or non-infectious pneumonitis; or suspected ILD or non-infectious pneumonitis at screening that cannot be excluded by imaging.\n8. Clinically significant pulmonary impairment caused by pulmonary comorbidities, including but not limited to any underlying pulmonary conditions (e.g., pulmonary embolism within 3 months prior to the first dose, severe asthma, severe chronic obstructive pulmonary disease \\[COPD\\], restrictive lung disease, pleural effusion, etc.) or any autoimmune, connective tissue, or inflammatory diseases potentially involving the lungs (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.).\n9. Active chronic inflammatory bowel disease, gastrointestinal obstruction, severe ulceration, gastrointestinal perforation, intra-abdominal abscess, or acute gastrointestinal hemorrhage.\n10. Active autoimmune diseases requiring systemic therapy within the past 2 years (including but not limited to autoimmune hepatitis, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, etc.); systemic therapy is defined as disease-modifying agents, immunosuppressants, or systemic corticosteroids (\\>10 mg\u002Fday prednisone or equivalent). Note: Hormone replacement therapies, such as thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency, are not considered systemic therapies. Patients who have received systemic corticosteroid therapy at a dose of \\>10 mg\u002Fday prednisone or equivalent, or other immunosuppressive medications within 2 weeks prior to the first dose are excluded.\n11. Known active pulmonary tuberculosis (TB). Subjects with suspected active TB must undergo clinical evaluation to rule out the diagnosis.\n12. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n13. Active hepatitis B \\[hepatitis B surface antigen (HBsAg) positive with HBV-DNA ≥500 IU\u002FmL or above the lower limit of detection (whichever is higher)\\] or active hepatitis C \\[hepatitis C antibody positive with HCV-RNA above the lower limit of detection\\]. Note: HBsAg-positive subjects are required to receive anti-HBV antiviral therapy throughout the study treatment period.\n14. Known positive human immunodeficiency virus (HIV) test result or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.\n15. Known hypersensitivity to disitamab vedotin, toripalimab, platinum-based agents, pemetrexed, paclitaxel, docetaxel, or any of their excipients (including polysorbate-20); known history of severe hypersensitivity reactions to other monoclonal antibodies.\n16. Major surgical procedure within 4 weeks prior to the first dose, or anticipated need for major surgery during the study period.\n17. Serious infection within 4 weeks prior to the first dose, including but not limited to infections with complications requiring hospitalization, sepsis, or severe pneumonia; active infection requiring systemic anti-infective therapy within 2 weeks prior to the first dose.\n18. Receipt of non-specific immunomodulatory therapy (including but not limited to interferon, IL-2) or approved traditional Chinese medicine preparations with anti-tumor indications within 2 weeks prior to the first dose.\n19. Administration of a live vaccine within 30 days prior to the first dose, or planned live vaccination during the study period.\n20. Rapid disease deterioration observed during the screening period prior to the first dose, such as significant decline in performance status.\n21. Pregnant or breastfeeding women.\n22. Presence of local or systemic diseases attributable to non-malignant causes, or conditions secondary to the tumor, that may confer significant medical risk and\u002For uncertainty in survival assessment, such as leukemoid reaction or cachexia.\n23. Documented severe dry eye syndrome, severe meibomian gland disease and\u002For blepharitis, or history of corneal disease that impairs delayed corneal healing.\n24. Any condition that, in the opinion of the investigator, may interfere with the evaluation of the investigational drug, compromise patient safety, or confound the interpretation of study results; or any other condition deemed by the investigator to render the subject unsuitable for participation in this study.","70 Years",{"count":196,"type":21},50,[24],"This study is a phase 2 open-label, single-center clinical study to evaluate the efficacy and safety SKB264 in combination with toripalimab in patients with unresectable stage III non-small cell lung cancer",[200],"Non Small Cell Lung Cancer (Stage III)","2026-03-30",{"date":203,"type":34},"2026-04-03",{"date":205,"type":21},"2026-05-10",{"date":207,"type":21},"2029-12-31",{"name":209,"class":41},"Hunan Province Tumor Hospital",{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":22,"phases":219,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":68},"100603161","phase-2-hearts-trial-for-thoracic-cancers-100603161","NCT07132918","HEARTS Trial for Thoracic Cancers","The cARdiac Radiation Therapy Sparing (HEARTS) for Thoracic Cancers","Inclusion Criteria:\n\n* Age \\> 18 years at the time of consent.\n* Dosimetric eligibility criteria met using endpoints from QUANTEC (\\>10% of heart receives \\> 25 Gy) as determined through rapid auto-planning\n* Participants with histologically or cytologically proven AJCC, 8th edition including:\n\n  * Stage IIB, IIIA, IIIB, IIIC, or IV non-operable non-small cell lung cancer\n  * Limited stage small cell lung cancer, once daily treatment (excluding twice per day fractionation schemes). Stage I-III N0-2 disease esophageal\u002Fesophagogastric cancer\n  * Stage II or III thymoma\u002Fthymic carcinoma\n  * Other cancers in the thoracic region that meet the dosimetric and other clinical trial criteria, for example lymphoma sarcoma.\n* Participants must have a course of daily fractionated RT planned of at least 15 treatment fractions, typically ranging from 1.8 to 4 Gy\u002Ffraction\n\nExclusion Criteria:\n\n* Definitive clinical or radiologic evidence of metastatic disease with life expectancy \\\u003C12 months\n* Prior thoracic radiotherapy significantly overlapping the heart region\n* Contraindications to MRI\n* Severe, active co-morbidity defined as follows: New York Heart Association Functional Classification III\u002FIV are not eligible.",{"count":218,"type":21},60,[24],"The goal of this clinical trial is to compare a new way of using magnetic resonance-guided adaptive radiation therapy (MRgART) to the standard of care linear accelerator (LINAC) radiation treatment in people with cancer in the thoracic region near the heart.\n\nThe main question it aims to answer is whether MRgART affects the heart differently than LINAC.\n\nParticipants will:\n\n* Receive radiation therapy\n* Undergo MRIs and bloodwork\n* Complete quality of life questionnaires",[222,223,224,225,226],"Non-Small Cell Lung Cancer (Stage III)","Esophageal Cancer Stage I-III","Esophagogastric Cancer Stage I-III","Thymoma and Thymic Carcinoma Stage II-III","Other Cancers in the Thoracic Region","2026-03-09",{"date":229,"type":34},"2026-03-11",{"date":231,"type":34},"2025-10-08",{"date":233,"type":21},"2029-03",{"name":235,"class":41},"University of Wisconsin, Madison",{"id":237,"slug":238,"hasResults":11,"nctId":239,"briefTitle":240,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":242,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":243,"targetDuration":4,"studyType":22,"phases":245,"briefSummary":246,"conditions":247,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":68},"100407442","phase-2-adjuvant-ctdna-adapted-personalized-treatment-in-early-stage-nsclc-adapt-e-100407442","NCT04585477","Adjuvant ctDNA-Adapted Personalized Treatment in Early Stage NSCLC (ADAPT-E)","Inclusion Criteria\n\n1. Pathologically (histologically or cytologically proven) NSCLC. Tumors with any component of small cell lung cancer are not allowed.\n\n   Adenocarcinoma patients must NOT be positive for EGFR Exon 19 deletion or L858R mutation, or ALK or ROS1 rearrangement.\n2. AJCC 8th edition clinical or pathological stage IA2 to IIIC or locoregionally recurrent disease. Stage IA1 tumors are excluded unless recurrent with radiographic solid component -or- pathologic invasive component of \\> 10 mm.\n3. Received curative intent therapy with surgery and\u002For radiation. Note: May have received chemotherapy.\n4. Completed all intended therapy (surgery, radiation, and\u002For chemotherapy) - AND- no more than 32 weeks has elapsed after the last day of this therapy.\n5. No known current radiographic or pathologic residual\u002Frecurrent disease (in the investigator's opinion) after completion of all intended therapy (for example, positive margins after surgery without adjuvant radiotherapy, or unequivocal radiographic evidence of residual or recurrent disease)\n6. Pre-treatment tumor tissue or tumor DNA sample is believed to be available for analysis\n7. Not received immunotherapy (PD-1, PD-L1, or CTLA-4 antibodies) or be intended to receive immunotherapy, apart from this study.\n8. Not received another systemic anti-cancer investigational product during the 4 weeks prior to enrollment.\n9. Aged 18 years or older\n10. ECOG Performance Status of 0 or 1 (Appendix B)\n11. Life expectancy ≥ 12 weeks\n12. Acceptable laboratory parameters:\n13. Absolute neutrophil count \\> 1.0 x 109\u002FL\n14. Platelets \\> 75 x 109\u002FL\n15. Hemoglobin ≥ 9.0 g\u002FdL\n16. Creatinine ≤ 1.5 x ULN; or Measured creatinine clearance (CL) \\>40 mL\u002Fmin; or Calculated creatinine CL\\>40 mL\u002Fmin by the Cockcroft-Gault formula (Cockcroft and Gault 1976)\n17. Serum bilirubin ≤ 1.5 x upper limit of normal (ULN). This will not apply to subjects with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of evidence of hemolysis or hepatic pathology) who will be allowed in consultation with their physician.\n18. AST (SGOT)\u002FALT (SGPT) ≤ 2.5 x institutional upper limit of normal (ULN)\n19. Ability to understand and the willingness to sign the written IRB approved informed consent document.\n20. Women of childbearing potential or their male partner must agree to use a highly effective method of contraception from enrollment until 8 months after final study therapy. (see section 4.6.1)\n21. Body weight \\>30kg\n\nExclusion Criteria\n\n1. Involvement in the planning and\u002For conduct of the study\n2. History of Grade 3 or higher pneumonitis from prior radiation; patients with grade 2 radiation pneumonitis may be considered for enrollment with permission from the Protocol Director or Co-Director.\n3. History of another primary malignancy and currently undergoing active treatment Exception: May participate if receiving adjuvant endocrine therapy for breast or prostate cancer.\n4. Expected to require ongoing chronic treatment with systemic immunosuppressive medication after enrollment.\n\n   Exceptions: intranasal, inhaled, or topical corticosteroids or systemic corticosteroids at physiological doses, not to exceed 10 mg\u002Fday of prednisone equivalent\n5. Any unresolved toxicity CTCAE \\> Grade 2 from prior therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.\n\n   * Subjects with Grade \\> 2 neuropathy will be evaluated on a case by case basis after consultation with the Protocol Director \u002F Principal Investigator\n   * Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by treatment with durvalumab may be included (ie, hearing loss) with permission from the Protocol Director \u002F Co-Director.\n6. Active or prior documented autoimmune or inflammatory disorders which could limit the subjects ability to receive durvalumab on the study (including inflammatory bowel disease \\[eg, colitis or Crohn's disease\\], diverticulitis \\[with the exception of diverticulosis\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis; Graves' disease; rheumatoid arthritis; hypophysitis; uveitis; etc\\]). The following may be taken in to considerations as exceptions to this criterion:\n\n   1. Vitiligo or alopecia\n   2. Hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement\n   3. Chronic skin condition not requiring systemic therapy\n   4. Those without active disease in the last 5 years may be included with permission from the Protocol Director \u002F Co-Director.\n   5. Celiac disease controlled by diet alone\n7. History of primary immunodeficiency\n8. History of organ transplant requiring therapeutic immunosuppression\n9. Active infection including:\n\n   * Grade 3 or higher clinically significant infection\n   * Active known Hepatitis B \\[known positive results for HBV surface antigen (HBsAg) within 2 months prior to enrollment\\]. EXCEPTION: Subjects with a past or resolved HBV infection, defined as the presence of hepatitis B core antibody (anti HBc) and absence of HBsAg are eligible.\n   * Active known Hepatitis C (HCV) EXCEPTION: Subjects positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA\n   * Active known tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).\n   * Active known HIV: tested positive for human immunodeficiency virus (HIV) (positive HIV 1\u002F2 antibodies)\n10. Receipt of live (growth\u002Freplication competent) attenuated vaccine within 30 days prior to enrollment.\n\n    Note: Subjects, if enrolled, should not receive live vaccine while receiving the investigational product (IP), and through 30 days after the last dose of IP.\n11. Uncontrolled intercurrent illness, including but not limited to clinically significant:\n\n    * Symptomatic congestive heart failure\n    * Uncontrolled hypertension\n    * Unstable angina pectoris\n    * Cardiac arrhythmia\n    * Interstitial lung disease (presence of radiation pneumonitis on CT scan is allowed)\n    * Serious chronic gastrointestinal conditions associated with diarrhea\n    * Psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the subject to give written informed consent.\n12. Female subjects who are pregnant or breast feeding.\n13. Any other medical condition that, in the investigator's opinion, makes the subject unsuitable for enrollment and study procedures.\n14. Female subjects who are pregnant or breast-feeding; or subjects of reproductive potential of any gender who are not employing or who do not agree to employ an effective method of birth control (see Section 4.7) prior to trial enrollment.",true,{"count":244,"type":21},80,[24],"In this study circulating tumor DNA (ctDNA) blood testing is used to detect the residual blood cancer. If residual cancer using this blood test is detected there may be at higher risk of having the cancer return. The study is going to test whether or not the number of circulating cancer cells detected in the blood can be reduced by administration durvalumab after the standard treatment if you are tested positive for the residual cancer.",[86,248,249,27],"Non-small Cell Lung Cancer Stage I","Non-small Cell Lung Cancer Stage II","2026-02-07",{"date":252,"type":34},"2026-02-10",{"date":254,"type":34},"2021-04-08",{"date":256,"type":21},"2026-12-30",{"name":258,"class":41},"Stanford University",{"id":260,"slug":261,"hasResults":11,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":265,"eligibilityCriteria":266,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":267,"targetDuration":4,"studyType":268,"phases":4,"briefSummary":269,"conditions":270,"keywords":272,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":284},"100564824","study-of-antitumor-immune-response-after-ccrt-and-io-treatment-in-non-resectable-iii-stage-nsclc-patients-100564824","NCT06634199","Study of Antitumor Immune Response After cCRT and IO Treatment in Non-resectable III Stage NSCLC Patients","Study of Antitumor Immune Response Generated After Concurrent Chemo-radiotherapy (cCRT) and IO Treatment in Non-resectable Stage IIIA\u002FB and IIIC NSCLC Patients Treated in Real World.","SIENNA","Inclusion Criteria:\n\n* Patients with histologically- or cytologically- documented NSCLC who present unresectable stage IIIA-IIIB-IIIC disease, according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology).\n* ECOG 0-1.\n* PDL1\\>1%.\n* Age ≥ 18 years at time of study\n* Patients without progression after cCRT, that are going to receive IO treatment (Durvalumab) for 12 months as subsequent treatment as per standard clinical practice\n* Patient capable of proper therapeutic compliance and accessible for correct follow-up.\n* Patients must have signed, dated and IRB\u002FEC-approved written informed consent form in accordance with regulatory and institutional guidelines.\n\nExclusion Criteria:\n\n* Patients who refuse to sign and date an IRB\u002FIEC-approved written informed consent form.\n* No possibility of venipuncture\n* Any medical, mental, or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information.",{"count":196,"type":21},"OBSERVATIONAL","Observational, multicenter, one-arm, non-comparative study. Data will be recorded in a retrospectively manner. The study will be based on secondary data collected from patient clinical chart completed by the doctor during routine visits. The primary objective is describe the antitumor immune response generated in the context of IO (immunotherapy) treatment after cCRT in patients with unresectable NSCLC treated in real world.",[27,271],"PDL1 Gene Mutation",[175,273,274,275],"Chemo radiotherapy","ctDNA","Inmunotherapy","2026-01-26",{"date":278,"type":34},"2026-01-28",{"date":280,"type":34},"2024-10-03",{"date":282,"type":21},"2027-11-04",{"name":162,"class":41},22,{"id":286,"slug":287,"hasResults":11,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":291,"eligibilityCriteria":292,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":293,"targetDuration":4,"studyType":22,"phases":295,"briefSummary":296,"conditions":297,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":68},"100608668","phase-2-the-ivo-lung-study-100608668","NCT07204548","The IVO-LUNG Study","Ivonescimab Consolidation After Concurrent\u002FSequential Chemoradiation for Unresectable Stage III NSCLC- A Phase II Study","IVO Lung","Inclusion Criteria:\n\n1. Provide voluntary written informed consent.\n2. age: 18-75 years old\n3. ECOG performance status: 0 or 1\n4. With a life expectancy of ≥ 3 months.\n5. Patients with radiologically confirmed, treatment-naïve, unresectable Stage III NSCLC (staged according to the American Joint Committee on Cancer, 8th edition) who did not progress after definitive concurrent\u002Fsequential chemoradiotherapy. Induction therapy prior to chemoradiotherapy was permitted.\n6. Negative for EGFR L858R\u002F19del, ALK fusion, ROS1 fusion, RET fusion, BRAF V600E mutation, NTRK fusion, and MET exon 14 skipping mutation.\n7. Presence of at least one measurable lesion per RECIST v1.1, which is suitable for accurate and reproducible repeated measurements.\n8. For the exploration of efficacy-related biomarkers, the submission of tumor tissue, peripheral blood, and stool samples is required. Patients with biologically unavailable samples may be granted an exemption from this requirement.\n9. Adequate organ function based on examinations within 14 days prior to the initiation of study treatment.\n10. Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to the first dose (if the urine pregnancy test result cannot be confirmed as negative, a serum pregnancy test must be performed, and the serum result shall be considered definitive). If a female subject of childbearing potential engages in sexual activity with a non-sterilized male partner, the subject must use a highly effective method of contraception starting from screening and must agree to continue its use for 120 days after the last dose of the study drug; the decision to discontinue contraception after this time point should be discussed with the investigator.\n11. Non-sterilized male subjects who engage in sexual activity with a female partner of childbearing potential must use a highly effective method of contraception from the start of screening until 120 days after the last dose; the decision to discontinue contraception after this time point should be discussed with the investigator.\n12. The subject is willing and able to comply with scheduled visits, the treatment plan, laboratory tests, and other study requirements.\n\nExclusion Criteria:\n\n1. Patients with non-small cell lung cancer (NSCLC) that contains a small cell carcinoma component.\n2. History of other malignancies (except carcinoma in situ of the cervix, non-melanoma skin cancer, bladder carcinoma in situ, etc.) or presence of other life-threatening diseases that may affect the completion of the study.\n3. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study.\n4. Imaging during the screening period shows tumor invasion or the presence of significant necrosis or cavitation, and the investigator judges that study entry would pose a bleeding risk.\n5. History of severe bleeding tendency or coagulation dysfunction; presence of clinically significant bleeding symptoms within 1 month prior to the first dose, including but not limited to gastrointestinal bleeding, hemoptysis (defined as coughing up or spitting up ≥1 teaspoon of fresh blood or small blood clots, or coughing up blood without sputum; subjects with blood-tinged sputum are allowed), epistaxis (excluding minor nosebleeds and blood-tinged postnasal drip); received continuous antiplatelet or anticoagulant therapy within 10 days prior to the first dose.\n6. Tumor compression of surrounding vital organs (e.g., esophagus) accompanied by related symptoms, compression of the superior vena cava, or invasion of mediastinal great vessels, heart, etc.\n7. Received non-specific immunomodulatory therapy (e.g., interleukin, interferon, thymosin, tumor necrosis factor, etc., excluding IL-11 for treating thrombocytopenia) within 2 weeks prior to the first dose; received Chinese herbal medicine or Chinese proprietary medicine with anti-tumor indications within 2 weeks prior to the first dose.\n8. Previously received surgical resection and experienced postoperative recurrence of Stage III NSCLC.\n9. History of non-infectious pneumonitis\u002Finterstitial lung disease requiring systemic glucocorticoid therapy, or current non-infectious pneumonitis.\n10. Presence of uncontrolled serous cavity effusion.\n11. Presence of uncontrolled comorbid diseases, including but not limited to decompensated liver cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, severe active peptic ulcer disease or gastritis, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements or impair the ability to provide written informed consent.\n12. History of myocarditis, cardiomyopathy, or malignant arrhythmia. Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association Class II or above), or vascular disease (e.g., aortic aneurysm at risk of rupture) requiring hospitalization within 12 months prior to the first dose, or other cardiac damage that may affect the evaluation of study drug safety (e.g., poorly controlled arrhythmia, myocardial ischemia); History of esophageal\u002Fgastric varices, severe ulcer, unhealed wound, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to the first dose; Any arterial thromboembolic event, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 6 months prior to the first dose; Acute exacerbation of chronic obstructive pulmonary disease within 1 month prior to the first dose; Current hypertension with systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg after oral antihypertensive medication.\n13. Severe infection within 4 weeks prior to the first dose, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; Active infection requiring systemic anti-infective therapy within 2 weeks prior to the first dose (excluding antiviral therapy for hepatitis B or C).\n14. Active or history of definite autoimmune diseases, including but not limited to inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea), systemic lupus erythematosus, or other conditions unsuitable for treatment with immune checkpoint inhibitors.\n15. History of immunodeficiency; Positive HIV antibody test; Current long-term use of systemic corticosteroids or other immunosuppressants.\n16. Known active tuberculosis (TB); subjects suspected of having active TB require clinical evaluation to rule it out (e.g., sputum TB test, chest X-ray, etc.); Known active syphilis infection.\n17. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n18. Subjects with active hepatitis B (HBsAg positive and HBV-DNA \\>1000 copies\u002Fml or above the lower limit of detection); Subjects with active hepatitis C (HCV-RNA positive).\n19. Major surgery or severe trauma within 30 days prior to the first dose, or planned major surgery within 30 days after the first dose (as determined by the investigator); Minor local surgery within 3 days prior to the first dose (excluding PICC line placement, port implantation).\n20. Received live attenuated vaccines within 30 days prior to the first dose, or plans to receive live attenuated vaccines during the study period; Note: Live attenuated influenza vaccines cannot be administered within 90 days after the last dose of study treatment.\n21. Known allergy to any component of the study drug; History of severe hypersensitivity reactions to other monoclonal antibodies.\n22. Known history of mental illness, drug abuse, alcoholism, or substance abuse.\n23. Pregnant or lactating women.\n24. Any disease, treatment, or laboratory abnormality, historical or current, that may confound the study results, interfere with the subject's full participation in the study, or for which participation may not be in the best interest of the subject.\n25. Uncontrolled metabolic disorders; or local or systemic diseases not caused by malignancy; or secondary diseases or symptoms caused by the tumor that could pose a high medical risk and\u002For uncertainty in survival evaluation, such as tumor-related leukemoid reaction (white blood cell count \\>20×10⁹\u002FL), cachexia (e.g., known weight loss \\>10% in the 3 months prior to screening), etc.",{"count":294,"type":21},63,[24],"This Phase II, open-label, single-arm study evaluates the efficacy and safety of one-year Ivonescimab consolidation therapy in patients with unresectable Stage III NSCLC who have not progressed after definitive chemoradiotherapy.",[200],"2025-09-24",{"date":300,"type":34},"2025-10-02",{"date":302,"type":21},"2025-10",{"date":304,"type":21},"2029-10",{"name":306,"class":41},"Sun Yat-sen University",{"id":308,"slug":309,"hasResults":11,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":313,"eligibilityCriteria":314,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":315,"targetDuration":4,"studyType":22,"phases":316,"briefSummary":317,"conditions":318,"keywords":320,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":68},"100592844","phase-2-neoadjuvant-durvalumab-and-chemotherapy-followed-by-surgerycrt-and-durvalumab-in-borderline-resectable-stage-iii-nsclc-100592844","NCT06998719","Neoadjuvant Durvalumab and Chemotherapy Followed by Surgery\u002FCRT and Durvalumab in Borderline Resectable Stage III NSCLC","A Phase II, Interventional Study of Neoadjuvant Durvalumab and Platinum-based Chemotherapy, Followed by Surgery and Adjuvant Durvalumab or Chemoradiotherapy and Consolidation Durvalumab, in Borderline Resectable Stage III NSCLC (ACCESS)","ACCESS","Inclusion Criteria:\n\n* 1\\. Participant must be ≥ 18 years, at the time of screening. 2. Histologically or cytologically documented NSCLC. 3. Deemed borderline resectable at baseline, confirmed by MDT evaluation at diagnosis.\n\n  4\\. Previously untreated and pathologically confirmed stage III (according to Version 8 of the IASLC Staging Manual in Thoracic Oncology2016)\n  1. Nodal status should be investigated with whole body FDG-PET, plus contrast-enhanced computed tomography, and it is optional and decided by investigator that nodal status be proven by biopsy via endobronchial ultrasound, mediastinoscopy, or thoracoscopy.\n  2. Mandatory brain MRI with IV contrast, if not available, it is mandatory to take brain computed tomography with IV contrast at the time of staging.\n\n     5\\. WHO or ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline or day of first dose.\n\n     6\\. Participants must have been confirmed as EGFR\u002FALK wild type via an appropriately validated local test. Participants with known sensitising EGFR mutations or ALK rearrangements are excluded from the study.\n\n     7\\. At least one lesion not previously irradiated that qualifies as a RECIST 1.1 TL at baseline and can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with computed tomography or MRI and is suitable for accurate repeated measurements.\n\n     8\\. Adequate organ and bone marrow function as follows:\n* Haemoglobin ≥ 9.0 g\u002FdL.\n* Absolute neutrophil count ≥ 1.5 × 109\u002FL.\n* Platelet count ≥ 100×109\u002FL.\n* Serum bilirubin ≤ 1.5×the ULN or ≤ 3×ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinaemia).\n* Alanine aminotransferase and AST ≤ 2.5×ULN.\n* Calculated CrCL \\> 40 mL\u002Fmin as determined by Cockcroft Gault (using actual body weight).\n\nMales:\n\nCrCL (mL\u002Fmin) = Weight (kg) × (140 - Age) 72 × serum creatinine (mg\u002FdL)\n\nFemales:\n\nCrCL (mL\u002Fmin) = Weight (kg) × (140 - Age) × 0.85 72 × serum creatinine (mg\u002FdL) 9. Minimum life expectancy of 12 weeks. 10. The participant should be deemed to have adequate cardiac and lung function, according to a multidisciplinary assessment. A pre- or post-bronchodilator FEV1 of 1.0 L and \\>40% post-operative predicted value. Use of these cut-off values to assess candidacy for resection on pre-treatment risk assessment. (Surgical Eligible) 11. Minimum body weight of 30 kg. 12. Negative pregnancy test (serum) for FOCBP for female. 13. Male participants who intend to be sexually active with a female partner of child-bearing potential must be surgically sterile or using an acceptable method of contraception from the time of screening, while receiving study intervention, SoC Chemotherapy or CRT, and for 90 days after the last dose of durvalumab and for periods specified in the local prescribing information\u002FSmPC relating to contraception and the time limit for such precautions for SoC agents to prevent pregnancy in a partner. Male participants must not donate or bank sperm during this same time period.\n\n14\\. Female participants must be for 1 year or more post-menopausal, surgically sterile, or using at least one highly effective method of contraception: a highly effective method of contraception is defined Non-hormonal\n\n* Total sexual abstinence (evaluate in relation to the duration of the clinical study and the preferred and usual lifestyle choice of the participant)\n* Vasectomised sexual partner (with participant assurance that partner received post-vasectomy confirmation of azoospermia)\n* Tubal occlusion Intrauterine device (provided coils are copper banded) Hormonal\n* Implants: Etonogestrel-releasing implants (e.g. Implanon® or Norplant®)\n* Intravaginal devices: Ethinylestradiol\u002Fetonogestrel-releasing intravaginal devices (e.g. NuvaRing®)\n* Injection: Medroxyprogesterone injection (e.g. Depo-Provera®)a\n* Combined Pill: Normal and low dose combined oral contraceptive pill\n* Patch: Norelgestromin\u002Fethinylestradiol-releasing transdermal system (e.g. Ortho Evra®)\n* Mini pill: Progesterone based oral contraceptive pill using desogestrel: Cerazette® is currently the only highly effective progesterone-based Levonorgestrel-releasing intrauterine system (e.g., Mirena®)\n\n  1. Females \\\u003C 50 years old are considered post-menopausal if they have been amenorrhoeic for 12 months or more prior to enrolment following cessation of exogenous hormonal treatment and follicle-stimulating hormone (FSH) levels in the post-menopausal range.\n  2. Females ≥ 50 years old are considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatment, or had radiation-induced menopause with last menses \\> 1 year ago, or had chemotherapy-induced menopause with last menses \\> 1 year ago.\n  3. Female participants of child-bearing potential must agree to use at least one highly effective method of birth control (see Appendix G for complete list of highly effective birth control methods). They should have been stable on their chosen method of birth control for a minimum of 3 months prior to enrollment (screening), while receiving study intervention, SoC Chemotherapy or CRT, and for 90 days after the last dose of durvalumab and for periods specified in the local prescribing information\u002FSmPC relating to contraception and the time limit for such precautions for SoC agents. Cessation of birth control after this point should be discussed with a responsible physician.\n  4. Non-sterilised male partners of a female participant of child-bearing potential must use a male condom plus spermicide (condom alone in countries where spermicides are not approved) from the time of screening their female partner, while their female partner is receiving study intervention, SoC Chemotherapy or CRT, and for 90 days after the last dose of durvalumab and for periods specified in the local prescribing information\u002FSmPC relating to contraception and the time limit for such precautions for SoC agents.\n  5. Periodic abstinence, as well as the rhythm and withdrawal methods are not acceptable methods of birth control..\n\n     15\\. Capable of giving signed informed consent as described in Appendix which includes compliance with the requirements and restrictions listed in the ICF and in this CSP.\n\n     16\\. Provision of signed and dated written Optional Genetic Research Information informed consent prior to collection of samples for optional genetic research that supports the Genomic Initiative.\n\n     17\\. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n\n     Exclusion Criteria:\n     1. Existence of more than one primary tumor, such as: mixed small cell and NSCLC histology; synchronous or metachronous tumors that could represent distinct primary tumors.\n     2. History of another primary malignancy except for malignancy treated with curative-intent with no known active disease ≥ 5 years before the first dose of study intervention and of low potential risk for recurrence, basal cell carcinoma of the skin, squamous cell carcinoma of the skin or lentigo maligna that has undergone potentially curative therapy or adequately treated carcinoma in situ without evidence of disease.\n     3. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[eg, colitis or Crohn's disease\\], systemic lupus erythematosus, sarcoidosis, granulomatosis with polyangiitis, Graves ' disease, rheumatoid arthritis, hypophysitis, uveitis, autoimmune pneumonitis, and autoimmune myocarditis). The following are exceptions to this criterion:\n\n        \\- Participants with vitiligo or alopecia.\n\n        \\- Participants with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement.\n\n        \\- Any chronic skin condition that does not require systemic therapy.\n\n        \\- Participants without active disease in the last 5 years may be included but only after consultation with the Study Clinical Lead.\n\n        \\- Participants with coeliac disease controlled by diet alone.\n     4. Known active hepatitis infection, positive HCV antibody, HBsAg or HBV core antibody (anti-HBc), at screening. Participants with a past or resolved HBV infection (defined as the presence of anti-HBc and absence of HBsAg) are eligible. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Participants co-infected with HBV and HCV, or co-infected with HBV and HDV, namely: HBV positive (presence of HBsAg and\u002For anti-HBcAb with detectable HBV DNA); AND\n\n        * HCV positive (presence of anti-HCV antibodies); OR\n        * HDV positive (presence of anti-HDV antibodies).\n     5. Known to have tested positive for HIV (positive HIV 1 or 2 antibodies) or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).\n     6. History of active primary immunodeficiency.\n     7. Investigator judgement of one or more of the following:\n\n        * Mean resting corrected QT interval \\> 470 ms, obtained from triplicate ECGs performed at screening.\n        * History of QT prolongation associated with other medications that required discontinuation of that medication, or any current concomitant medication known to prolong the QT interval and cause TdP.\n        * Congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden cardiac death under 40 years of age in first-degree relatives.\n     8. Prior exposure to immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1 and anti-PD-L2 antibodies, excluding therapeutic anticancer vaccines.\n     9. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:\n\n        \\- Intranasal, inhaled, topical steroids or local steroid injections (eg, intra-articular injection).\n        * Systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or its equivalent.\n        * Steroids as premedication for hypersensitivity reactions or as an anti-emetic (eg, computed tomography scan premedication).\n     10. Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention.\n     11. Major surgical procedure or significant traumatic injury within 4 weeks of the first dose of study intervention.\n     12. Any medical contraindication to treatment with platinum-based doublet Chemotherapy, as listed in the local labelling.\n     13. Previous treatment in the present study or a previous durvalumab clinical study regardless of treatment arm assignment.\n     14. Participation in another clinical study with a study intervention administered in the last 4 weeks prior to first dose of durvalumab or concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.\n     15. Participants with a known hypersensitivity to durvalumab or any excipients of the product(s).\n     16. Involvement in the planning and\u002For conduct of the study (applies to both AstraZeneca staff and\u002For staff at the study site).\n     17. Judgement by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.\n     18. Female participants who are pregnant or breastfeeding or male or female participants of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy. Specifically, regarding the receipt of SoC chemotherapy or chemoradiotherapy, participants should be willing to follow the local prescribing information relating to contraception, the time limits for such precautions, and any additional restrictions for the agents administered.\n     19. Participants with a documented test result confirming the presence of a known EGFR or ALK sensitizing mutation is excluded from the study.\n     20. Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies) ≤28 days prior to the first dose of study drug If sufficient wash-out time has not occurred due to the schedule or PK properties of an agent, a longer wash-out period will be required, as agreed by AstraZeneca\u002FMedImmune and the investigator.\n     21. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria:\n\n     \u003C!-- -->\n\n     1. Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.\n\n     22\\. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician.\n\n     (2) History of allogenic organ transplantation. (3) History of leptomeningeal carcinomatosis",{"count":244,"type":21},[24],"A Phase II, interventional study of neoadjuvant durvalumab (MEDI 4736) and platinum-based Chemotherapy, followed by either surgery and adjuvant durvalumab or chemoradiotherapy (CRT) and consolidation durvalumab, in participants with borderline resectable stage III Non-small Cell Lung Cancer (NSCLC) (ACCESS)",[27,319],"Borderline Resectable Carcinoma",[321,86,319],"Neoadjuvant therapy","2025-05-22",{"date":324,"type":34},"2025-05-31",{"date":326,"type":21},"2025-07",{"date":328,"type":21},"2027-12",{"name":330,"class":41},"Bi Nan",{"id":332,"slug":333,"hasResults":11,"nctId":334,"briefTitle":335,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":337,"targetDuration":4,"studyType":22,"phases":339,"briefSummary":340,"conditions":341,"keywords":342,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":351,"locationsCount":4},"100590036","phase-2-the-efficacy-and-safety-of-sintilimab-plus-chemotherapy-in-surgical-conversion-for-patients-with-unresectable-stage-iiib-iiic-nsclc-a-prospective-single-arm-phase-ii-study-100590036","NCT06962189","The Efficacy and Safety of Sintilimab Plus Chemotherapy in Surgical Conversion for Patients With Unresectable Stage IIIB-IIIC NSCLC: A Prospective, Single-Arm, Phase II Study","Inclusion Criteria:\n\n* 1\\. Patients voluntarily participate in this study and sign informed consent forms (including consent for relevant testing of collected biological samples).\n\n  2\\. Histologically or cytologically confirmed NSCLC with no prior antitumor therapy (including systemic medications or local treatments).\n\n  3.Treatment-naïve patients with unresectable stage IIIB-IIIC NSCLC. 4. Evaluated by a multidisciplinary team (MDT): Surgical resection is not the current preferred treatment option, but radical resection of the primary lung lesion is feasible after induction chemoimmunotherapy, and metastatic contralateral\u002Fsupraclavicular lymph nodes (if present) are amenable to definitive radiotherapy.\n\n  5\\. Aged 18-75 years, regardless of gender. 6. ECOG performance status 0-1. 7. At least one measurable lesion per RECIST v1.1 criteria. 8. All suspicious mediastinal lymph nodes (e.g., pathologically enlarged or PET-CT-suggested malignancy) must undergo pathological confirmation via endobronchial ultrasound (EBUS), thoracoscopy, or mediastinoscopy if technically feasible.\n\n  9\\. Pulmonary function (e.g., FVC, FEV1, TLC, FRC, DLco) deemed adequate for planned lung resection by MDT assessment.\n\n  10\\. Absence of comorbidities that would elevate surgical risk to unacceptable levels.\n\n  11\\. Adequate organ function within 14 days prior to enrollment (no blood components, growth factors, or corrective therapies allowed during this period): Absolute neutrophil count ≥1.5×10⁹\u002FL, Platelets ≥100×10⁹\u002FL, Hemoglobin ≥90 g\u002FL, Serum albumin ≥35 g\u002FL TSH ≤1×ULN, Total bilirubin ≤1.5×ULN, ALT\u002FAST ≤3×ULN, INR ≤1.5 or PT ≤1.5×ULN, Serum creatinine ≤1.5×ULN 12. Non-sterilized or premenopausal female patients must use contraception (e.g., IUD, oral contraceptives, condoms) during the study and for 3 months post-treatment. Non-sterilized females must have a negative serum\u002Furine HCG test within 72 hours before enrollment, be non-lactating, and male patients with fertile partners must use effective contraception during the trial and for 3 months after the last dose.\n\nExclusion Criteria:\n\n* 1\\. Patients with NSCLC harboring driver mutations (e.g., EGFR, ALK, ROS1). 2. Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 therapies targeting T-cell co-stimulatory pathways.\n\n  3\\. History of concurrent or other malignancies within the past 3 years (except cured basal cell carcinoma of the skin or cervical carcinoma in situ).\n\n  4\\. Active hepatitis B\u002FC with poor response to antiviral therapy. 5. Active autoimmune diseases or history of autoimmune disorders (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism; vitiligo is permitted; childhood asthma resolved without intervention in adulthood is allowed; asthma requiring bronchodilators is excluded).\n\n  6\\. Current use of immunosuppressants or systemic corticosteroids (\\>10 mg\u002Fday prednisone equivalent) for immunosuppression within 2 weeks prior to enrollment.\n\n  7\\. Poorly controlled hypertension (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg) or uncontrolled cardiac conditions: NYHA class ≥II heart failure, Unstable angina, Myocardial infarction within 1 year, Clinically significant supraventricular\u002Fventricular arrhythmias requiring treatment, QTc \\>450 ms (men) or \\>470 ms (women).\n\n  8.Coagulopathy (INR \\>2.0, PT \\>16 s), bleeding tendency, or ongoing thrombolytic\u002Fanticoagulant therapy (prophylactic low-dose aspirin or LMWH is permitted).\n\n  9.Arterial\u002Fvenous thrombotic events within 6 months (e.g., cerebrovascular accident, transient ischemic attack, deep vein thrombosis, pulmonary embolism).\n\n  10.Hereditary or acquired bleeding\u002Fthrombotic disorders (e.g., hemophilia, thrombocytopenia).\n\n  11\\. Urinalysis showing proteinuria ≥++ with 24-hour urine protein \\>1.0 g. 12. Active infection, unexplained fever ≥38.5°C within 7 days prior to treatment, or baseline leukocyte count \\>15×10⁹\u002FL.\n\n  13\\. Congenital or acquired immunodeficiency (e.g., HIV infection). 14. Other factors deemed by the investigator to compromise patient safety or study outcomes (e.g., substance abuse, severe comorbidities, psychiatric disorders, or social circumstances affecting compliance).",{"count":338,"type":21},39,[24],"This study aimed to evaluate the conversion rate to curative-intent treatment in patients with unresectable stage IIIB-IIIC non-small cell lung cancer (NSCLC) following induction therapy with PD-1 blockade combined with chemotherapy, and to assess progression-free survival (PFS) in these patients who underwent curative-intent treatment .",[200],[117,343,344,119],"IIIB-IIIC stage","conversion therapy","2025-04-29",{"date":347,"type":34},"2025-05-08",{"date":349,"type":21},"2025-05-15",{"date":160,"type":21},{"name":352,"class":41},"Zhejiang University",{"id":354,"slug":355,"hasResults":11,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":360,"targetDuration":4,"studyType":22,"phases":362,"briefSummary":363,"conditions":364,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":4},"100585927","phase-2-integrating-surgery-and-radiotherapy-following-tislelizumab-based-conversion-therapy-in-n3-stage-iii-nsclc-100585927","NCT06908733","Integrating Surgery and Radiotherapy Following Tislelizumab-based Conversion Therapy in N3-Stage III NSCLC","Prognosis and Patient-Reported Outcomes of Combined Local Treatments (Surgery and Radiotherapy or Radiotherapy Alone) With Tislelizumab and Chemotherapy in Initial Stage III-N3 Non-Small Cell Lung Cancer: A Prospective, Open-Label, Single-Arm, Phase II Trial","Inclusion Criteria:\n\n1. Aged 18 years or older (inclusive);\n2. Willingness to participate and provide written informed consent;\n3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, with no deterioration in the two weeks prior to treatment, and an expected survival of at least 12 weeks;\n4. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), T1-4N3M0 (AJCC 9th edition); suspicious lymph nodes on whole-body 18F-fluorodeoxyglucose positron emission tomography (PET) or contrast-enhanced computed tomography (CT) or PET-CT should undergo invasive lymph node staging which can be confirmed through endobronchial ultrasound, mediastinoscopy, thoracoscopy, or needle biopsy; however, mandatory confirmation is not required for highly suspicious mediastinal lymph nodes in zones 5 and 6;\n5. For patients with non-squamous cell carcinoma, EGFR, ALK, etc., testing results based on tumor tissue or blood samples must be provided; for squamous NSCLC patients, if the sensitive gene mutation status is unknown, it is not required to perform such tests during screening;\n6. No prior systemic therapy or local treatment after diagnosis of NSCLC;\n7. At least one measurable lesion according to RECIST 1.1 criteria at baseline. The longest diameter should be ≥10 mm (if a lymph node, the shortest diameter should be ≥15 mm). The chosen method of measurement should be suitable for accurate repeated measurements, such as CT or MRI. If only one measurable lesion exists, it may be accepted as the target lesion, evaluated at least 14 days after diagnostic biopsy. Baseline imaging assessment should be performed within 28 days before the first dose of study medication;\n8. Women of childbearing potential must use effective contraception from screening until six months after discontinuation of study treatment and should not breastfeed. Prior to starting treatment, a negative pregnancy test is required, or one of the following criteria proving no risk of pregnancy: ① Postmenopausal defined as age greater than 50 years and amenorrhea for at least 12 months following cessation of all exogenous hormonal replacement therapy; ② Women under 50 years old who have been amenorrheic for 12 months or more after stopping all exogenous hormonal therapy and whose levels of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) fall within laboratory postmenopausal reference ranges are also considered postmenopausal; ③ History of irreversible sterilization surgery including hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, but not bilateral tubal ligation;\n9. Non-sterilized males must use barrier contraception (i.e., condoms) from screening until six months after discontinuation of study treatment; sterilized males are defined as: a. Males with azoospermia confirmed by semen sample examination prior to the study, serving as definitive evidence of male sterilization; b. In this study, males known to have \"low sperm count\" (meeting the definition of \"subfertility\") are still considered fertile and not infertile.\n\nExclusion Criteria:\n\n1. Diagnosed with Pancoast tumor;\n2. Pathologically confirmed large cell neuroendocrine carcinoma (LCNEC);\n3. Primary tumor or metastatic lymph nodes infiltrating major vessels\u002Faorta, trachea, esophagus, heart, etc.;\n4. Any of the following prior treatments: ① Previous lung surgery; ② Prior systemic chemotherapy, immunotherapy, targeted therapy, or any other anti-tumor treatment for lung cancer; ③ Known presence of epidermal growth factor receptor (EGFR) mutations, ALK rearrangements, ROS1 rearrangements, BRAF V600 mutations, RET rearrangements, MET exon 14 skipping mutations, NTRK1\u002F2\u002F3 rearrangements, or other sensitive mutations; ④ Prior radiotherapy to the lungs; ⑤ Major surgery within 14 days prior to first dose or within 28 days if not fully recovered from toxicity and\u002For complications; ⑥ Use of traditional Chinese medicine with anti-tumor effects is allowed if discontinued at least 2 weeks before study drug administration and used for no more than 7 days;\n5. Diagnosis of other malignancies within the last 5 years, except for completely resected basal cell or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, or breast carcinoma in situ;\n6. Active autoimmune disease or history of autoimmune disease that may recur \\[excluding patients with well-controlled type 1 diabetes, hypothyroidism (if controlled by hormone replacement therapy alone), celiac disease, non-systemic dermatological conditions (e.g., vitiligo, psoriasis, alopecia), or any other disease not expected to recur without external triggers\\];\n7. Conditions requiring systemic corticosteroid therapy (\\> 10 mg\u002Fday prednisone or equivalent) or other immunosuppressive medications within 14 days prior to first dose \\[patients currently or previously using any of the following steroid regimens are eligible: adrenal replacement steroids (prednisone ≤ 10 mg\u002Fday or equivalent), minimal systemic absorption of local, ocular, intra-articular, intranasal, and inhaled corticosteroids, short-term (≤ 7 days) use of corticosteroids for prophylaxis or treatment of non-autoimmune conditions\\];\n8. Uncontrolled diabetes or laboratory abnormalities (\\> Grade 1) in potassium, sodium, or corrected calcium despite standard medical management within 14 days prior to first dose;\n9. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence within 2 weeks after intervention);\n10. History of interstitial lung disease or active interstitial lung disease, pneumonitis (non-infectious), or uncontrolled pulmonary conditions (e.g., pulmonary fibrosis, acute interstitial lung disease);\n11. Fever ≥ 38°C within 7 days prior to first dose, significant active infection, active tuberculosis, or active fungal, bacterial, or viral infections requiring systemic treatment \\[chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection patients receiving antiviral therapy are allowed\\];\n12. Untreated chronic hepatitis B or chronic HBV carriers with HBV DNA \\> 500 IU\u002FmL (or \\> 2500 copies\u002FmL) \\[inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B patients (HBV DNA \\\u003C 500 IU\u002FmL or \\\u003C 2500 copies\u002FmL) are eligible. Patients with detectable HBsAg or HBV DNA should be managed according to guidelines\\];\n13. Active HCV infection \\[patients with negative HCV antibody tests or positive HCV antibody but negative HCV RNA tests are eligible. Only patients with positive HCV antibody tests will undergo HCV RNA testing\\];\n14. Known history of HIV infection;\n15. Prior allogeneic stem cell transplantation or organ transplantation;\n16. Any cardiovascular risk factors: ① Cardiac chest pain within 28 days prior to first dose; ② Pulmonary embolism within 28 days prior to first dose; ③ Acute myocardial infarction within 6 months prior to first dose; ④ NYHA Class III or IV heart failure within 6 months prior to first dose; ⑤ ≥ Grade 2 ventricular arrhythmia within 6 months prior to first dose; ⑥ Cerebrovascular accident within 6 months prior to first dose; ⑦ Uncontrolled hypertension (≥ CTCAE Grade 3) despite medication within 28 days prior to first dose; ⑧ Syncope or seizure within 28 days prior to first dose; ⑨ Left ventricular ejection fraction (LVEF) ≤ 40% \\[patients with coronary artery disease, congestive heart failure not meeting the above criteria, or LVEF between 40% and 50% must receive optimized stable treatment as per their physician's advice, consulting a cardiologist if necessary\\];\n17. History of severe hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins;\n18. Allergy to pemetrexed, its excipients, cisplatin\u002Fcarboplatin, albumin-bound paclitaxel, or other platinum compounds; contraindications to cisplatin such as hearing impairment;\n19. Severe or uncontrolled systemic diseases, unstable or uncompensated respiratory, hepatic, or renal diseases;\n20. Insufficient bone marrow reserve or organ function, meeting any of the following laboratory limits (without corrective treatment within one week prior to blood draw): ① Absolute neutrophil count \\\u003C 1.5 × 10\\^9\u002FL; ② Platelet count \\\u003C 90 × 10\\^9\u002FL; ③ Hemoglobin \\\u003C 90 g\u002FL (\\\u003C 9 g\u002FdL); ④ Alanine aminotransferase \\> 2.5 × ULN; ⑤ Aspartate aminotransferase \\> 2.5 × ULN; ⑥ Total bilirubin \\> 1.5 × ULN (Gilbert syndrome allowed); ⑦ Creatinine \\> 1.5 × ULN (confirmation of creatinine clearance required); ⑧ Serum albumin (ALB) \\\u003C 25 g\u002FL; ⑨ INR or aPTT \\> 1.5 × ULN for patients not on anticoagulant therapy;\n21. Any immunotherapy (e.g., interleukins, interferons, thymosin, etc.) or experimental treatment within 14 days or 5 half-lives (whichever is longer) prior to first dose;\n22. Live vaccines or live-attenuated vaccines within 28 days prior to first dose \\[seasonal influenza vaccines are generally inactivated and allowed; intranasal vaccines are live and not allowed\\];\n23. Underlying diseases (including laboratory abnormalities), alcohol or drug abuse, or dependence that could interfere with study treatment administration, toxicity assessment, adverse event interpretation, or reduce compliance with the study protocol;\n24. Concurrent participation in another therapeutic clinical trial \\[concurrent participation in observational or non-interventional studies is allowed\\];\n25. Pregnant, lactating, or planning to become pregnant during the study period;\n26. Participants judged by the investigator to have poor compliance with study procedures and requirements due to a history of neurological or psychiatric disorders (including epilepsy or dementia), current mental health conditions, etc.;\n27. Participants deemed by the investigator to have any condition that endangers safety or interferes with study assessments.",{"count":361,"type":21},30,[24],"This is a prospective, open, multicenter, Phase II single-arm clinical study. In subjects with an initial stage of stage III-N3 non-small cell lung cancer (NSCLC) that was negative for sensitive gene mutations and had not received any systemic or local therapy (T1-4N3M0, excluding primary tumor or metastatic lymph node invasion of the aorta\u002Ftrachea\u002Fesophagus\u002Fheart, etc.); After 3-4 cycles of Tislelizumab combined with platinum-containing dual agents, the patients without disease progression were evaluated by MDT and selected according to the patient's wishes, including those who could receive conventional\u002Fstandard radical lung cancer surgery (excluding total lung resection). Conventional\u002Fstandard resection of primary, ipsilateral hilum and ipsilateral mediastinum combined with hypofractionted chemoradiotherapy of N3 metastatic lymph nodes was performed. For patients who are inoperable or unwilling to undergo surgery or intolerant to surgery, conventional concurrent chemoradiotherapy is given. Maintenance therapy with Tislelizumab was continued after local treatment until disease progression, drug intolerance as assessed by imaging, or after 1 year; Participants were followed up according to the procedure to evaluate efficacy and patient-reported outcomes.\n\nThe study included a screening period (no more than 28 days after subjects signed informed consent to the first dose), a treatment period (including Tislelizumab combined with chemotherapy-restaging and MDT-local treatment-maintenance therapy), and a follow-up period.\n\nThirty patients：30 patients Primary endpoint: 1-year EFS rate Secondary endpoints: EFS, OS, surgical rate, TTDM, TTLR, AEs, PROs Exploratory end points: Imaging efficacy, pathological efficacy and other relevant clinical outcomes; Predictive biomarkers based on tissue and blood samples.",[222],"2025-04-02",{"date":367,"type":34},"2025-04-03",{"date":369,"type":21},"2025-03-31",{"date":371,"type":21},"2029-12-30",{"name":373,"class":41},"Liaoning Cancer Hospital & Institute",{"id":375,"slug":376,"hasResults":11,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":380,"eligibilityCriteria":381,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":382,"targetDuration":4,"studyType":22,"phases":384,"briefSummary":386,"conditions":387,"keywords":388,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":68},"100585876","phase-4-chemoradiotherapy-with-surgery-followed-by-consolidation-durvalumab-100585876","NCT06908070","Chemoradiotherapy With Surgery Followed by Consolidation Durvalumab","ChemoRadiOtherapy With Surgery Followed by Consolidation Durvalumab for Initially Unresectable Stage III NSCLC (CROWD): a Phase IV Feasibility Trial","CROWD","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed stage III (non-N3) NSCLC (TNM 8th edition), before start of concurrent chemoradiotherapy (CRT).\n2. In case of suspected N2-disease, mediastinal invasive staging (EUS, EBUS and\u002For mediastinoscopy) to prove N2 involvement before start of concurrent CRT is preferred.\n3. Initial MDT recommendation for a non-surgical treatment comprising concurrent CRT (platinum-doublet, 60 Gy in 30 fractions of 2 Gy once daily) followed by durvalumab\n4. 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. Written informed consent and any locally required authorization (eg, European Union \\[EU\\] Data Privacy Directive in the EU) obtained from the patient\u002Flegal representative prior to performing any protocol-related procedures, including screening evaluations.\n5. Age \\> 18 years at time of study entry, i.e. the day of signing informed consent.\n6. Have a performance status of 0-1 on the ECOG Performance Scale at time of restaging.\n7. Body weight \\>30 kg\n8. Demonstrate adequate normal organ and marrow function, as deemed acceptable by the treating physician in the context of CRT.\n9. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n10. Must have a life expectancy of at least 12 weeks\n\nExclusion Criteria:\n\n1. Patients with TxN3 or M1 disease\n2. Patients with known actionable genomic alterations.\n3. The use of any CRT schemes other than those in ESMO recommendations (platinum doublet, 30 once-daily fractions of 2 Gy)\n4. Patients deemed inoperable based on cardiopulmonary function tests or comorbidity\n5. Unable to undergo CT-scan with iv-contrast\n6. Unable to remain supine for 15 min for the PET-low-dose CT scan\n7. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.\n8. Participation in another clinical study with an investigational product during the last 4 weeks.\n9. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study\n10. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria\n\n    1. Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.\n    2. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician.\n11. Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies) ≤4 weeks prior to the first dose of study drug. If sufficient wash-out time has not occurred due to the schedule or PK properties of an agent, a longer wash-out period will be required, as agreed by AstraZeneca\u002FMedImmune and the investigator.\n12. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.\n13. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.\n14. History of allogenic organ transplantation.\n15. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], diverticulitis \\[with the exception of diverticulosis\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\\]). The following are exceptions to this criterion:\n\n    1. Patients with vitiligo or alopecia\n    2. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\n    3. Any chronic skin condition that does not require systemic therapy\n    4. Patients without active disease in the last 5 years may be included but only after consultation with the study physician\n    5. Patients with celiac disease controlled by diet alone\n16. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent\n17. History of another primary malignancy except for\n\n    1. Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence\n    2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n    3. Adequately treated carcinoma in situ without evidence of disease\n18. History of leptomeningeal carcinomatosis\n19. History of active primary immunodeficiency\n20. Known active hepatitis infection, positive hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or HBV core antibody (anti-HBc), at screening. Participants with a past or resolved HBV infection (defined as the presence of anti-HBc and absence of HBsAg) are eligible. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Adjust wording as necessary and consider evaluating at screening for studies with known hepatotoxicity or other relevant requirements.\n\n    1. Participants co-infected with HBV and HCV, or co-infected with HBV and HDV, namely: HBV positive (presence of HBsAg and\u002For anti HBcAb with detectable HBV DNA); AND\n    2. HCV positive (presence of anti-HCV antibodies); OR\n    3. HDV positive (presence of anti-HDV antibodies).\n21. Known to have tested positive for human immunodeficiency virus (HIV) (positive HIV 1\u002F2 antibodies) or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).\n22. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:\n\n    1. Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)\n    2. Systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or its equivalent\n    3. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)\n23. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 90days after the last dose of IP.\n24. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy.\n25. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n26. Prior randomization or treatment in a previous durvalumab clinical study regardless of treatment arm assignment.\n27. Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.",{"count":383,"type":21},38,[385],"PHASE4","Lung cancer presents a significant treatment challenge, particularly in the heterogeneous stage III NSCLC patient population. While chemotherapy combined with high-dose radiotherapy (60 Gy in 30 fractions of 2 Gy once daily) is currently the recommended approach for unresectable stage III cases, it is associated with significant rates of locoregional and distant failures. Notably, the introduction of durvalumab consolidation therapy after chemoradiotherapy (CRT), as demonstrated in the PACIFIC study, has shown improved overall survival, primarily attributed to enhanced distant control. This improvement prompts further interest in investigating whether further improvements in locoregional control can lead to improved survival for patients. The present study aims to evaluate the feasibility of post-CRT surgery in patients with initially considered unresectable stage III (non-N3) NSCLC.",[27],[389,117,390,391,392],"Non-small cell lung cancer","Chemoradiotherapy","Surgery","Immunotherapy","2025-04-01",{"date":367,"type":34},{"date":396,"type":34},"2024-12-17",{"date":398,"type":21},"2028-12-17",{"name":400,"class":41},"Idris Bahce",{"id":402,"slug":403,"hasResults":11,"nctId":404,"briefTitle":405,"officialTitle":405,"acronym":406,"eligibilityCriteria":407,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":408,"targetDuration":410,"studyType":268,"phases":4,"briefSummary":411,"conditions":412,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":423,"locationsCount":68},"100256852","clinical-research-platform-into-molecular-testing-treatment-and-outcome-of-non-small-cell-lung-carcinoma-patients-100256852","NCT02622581","Clinical Research Platform Into Molecular Testing, Treatment and Outcome of (Non-)Small Cell Lung Carcinoma Patients","CRISP","Inclusion Criteria:\n\nPatients who meet all of the following criteria are eligible for the project:\n\n* Age ≥ 18 years\n* Able to understand and willing to sign written Informed Consent and to complete patient-reported-outcome assessment instruments\n\nMain project (Metatstatic NSCLC):\n\n* Confirmed non-small cell lung cancer (NSCLC)\n* Informed consent no later than four weeks after start of first-line systemic treatment or no later than four weeks after diagnosis for patients receiving \"best supportive care only\"\n* Stage IV, or stage IIIB\u002FC (UICC8) if patient is ineligible for curative surgery and\u002For radiochemotherapy\n* Systemic therapy or best supportive care\n\nSatellite Stage I\u002FII\u002FIII (NSCLC):\n\n* Confirmed non-small cell lung cancer (NSCLC)\n* Informed consent no later than four weeks after start of first anti-tumor treatment (including surgery and radiotherapy) or no later than four weeks after diagnosis for patients receiving \"best supportive care only\" (i.e. no anti-tumor treatment = no surgery, radiotherapy or systemic therapy)\n* Stage I, Stage II, stage IIIA, or stage IIIB\u002FC (UICC8)\n* Systemic (chemo)therapy and\u002For radiation therapy and\u002For surgery or best supportive care\n\nSatellite SCLC\n\n* Confirmed Small cell lung cancer (SCLC)\n* Informed consent no later than four weeks after start of first anti-tumor treatment or no later than four weeks after diagnosis for patients receiving \"best supportive care only\" (i.e. no anti-tumor treatment = no surgery, radiotherapy or systemic therapy)\n* Systemic (chemo)therapy and\u002For radiation therapy and\u002For surgery or best supportive care\n\nExclusion Criteria:\n\nnone",{"count":409,"type":21},12400,"3 Years","Open, non-interventional, prospective, multi-center clinical research platform with the main objective to assess molecular biomarker testing, treatment and outcome of patients with NSCLC or SCLC in Germany",[413,414,249,415,416,248],"Metastatic Non-small Cell Lung Cancer (NSCLC)","Non-small Cell Lung Cancer Metastatic","Non Small Cell Lung Cancer Stage III","Small-cell Lung Cancer","2025-02-14",{"date":419,"type":34},"2025-02-18",{"date":421,"type":34},"2015-12",{"date":328,"type":21},{"name":424,"class":41},"AIO-Studien-gGmbH",{"id":426,"slug":427,"hasResults":11,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":4,"eligibilityCriteria":431,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":432,"enrollmentInfo":433,"targetDuration":4,"studyType":22,"phases":435,"briefSummary":437,"conditions":438,"keywords":439,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":445,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":68},"100482094","sequential-chemo-immunotherapy-plus-thoracic-radiotherapy-for-elderly-andor-frail-stage-iii-non-small-cell-lung-cancer-100482094","NCT05557552","Sequential Chemo-immunotherapy Plus Thoracic Radiotherapy for Elderly And\u002For Frail Stage III Non-small-cell Lung Cancer","Sequential Chemo-immunotherapy Plus Thoracic Radiotherapy for Elderly And\u002For Frail Stage III Non-small-cell Lung Cancer Patients Unfit for Concurrent Chemoradiotherapy: an Open Label, Two Cohorts, Prospective Trial","Inclusion Criteria:\n\n1. Age ≥18 years at time of study entry\n2. Histologically documented diagnosis of unresectable stage III NSCLC;\n3. Fully-informed written consent obtained from patients;\n4. Unfit for concurrent chemoradiotherapy as determined by the multi-disciplinary team board due to one of the following reasons: (1) ECOG 2; (2)age≥70;(3) ECOG 1 and CCI≥1；\n5. Adequate bone marrow, liver and kidney function\n6. Life expectancy of at least 3 months\n7. At least one measurable (RECIST 1.1), thoracic lesion that can be irradiated\n8. Histologic or cytologic confirmation of small cell lung cancer\n9. Adequate pulmonary function with FEV1 \\>1 L or \\>30 % of predicted value and DLCO \\>30 % of predicted value\n\nExclusion Criteria:\n\n1. Previous chemo-, immuno- or radiotherapy for NSCLC\n2. Major surgical procedure last 28 days\n3. History of allogenic organ transplantation, autoimmune disease, immunodeficiency, hepatitis or HIV\n4. Uncontrolled intercurrent illness\n5. Other active malignancy\n6. Leptomeningeal carcinomatosis\n7. Immunosuppressive medication\n8. Pregnant or breastfeeding women","80 Years",{"count":434,"type":21},56,[436],"NA","Concurrent chemoradiotherapy without disease progression followed by consolidation durvalumab is standard of care for unresectable, stage III non-small-cell lung cancer (NSCLC) (the 'PACIFIC regimen'). However, many patients with poor performance status, older age or comorbidities may be ineligible for chemotherapy due to expected high toxicity. The present study aim to investigate the efficacy and toxicities of sequential chemo-immunotherapy plus thoracic radiotherapy for elderly and\u002For frail stage III NSCLC patients unfit for concurrent chemoradiotherapy, and to identify the optimal thoracic dose for this patient population.",[27],[440,441,442,443],"thoradic radiotherapy","non-small-cell lung cancer","chemo-immunotherapy","survival","2024-09-19",{"date":446,"type":34},"2024-09-23",{"date":448,"type":34},"2022-09-30",{"date":450,"type":21},"2026-09-30",{"name":452,"class":41},"Ruijin Hospital",{"id":454,"slug":455,"hasResults":11,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":4,"eligibilityCriteria":459,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":460,"targetDuration":4,"studyType":22,"phases":462,"briefSummary":463,"conditions":464,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":466,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":472,"locationsCount":68},"100418439","phase-2-neoadjuvant-immunotherapy-for-stage-iii-non-small-cell-lung-cancer-100418439","NCT04728724","Neoadjuvant Immunotherapy for Stage III Non-small Cell Lung Cancer","Neoadjuvant Sintilimab or Combined With Chemotherapy for Stage III Driven Gene Mutation Negative Non-small Cell Lung Cancer","Inclusion Criteria:\n\n1. The patient shall sign the Informed Consent Form.\n2. Aged 18 ≥ years.\n3. Histological or cytological diagnosis of NSCLC by needle biopsy, and stage III confirmed by imageological examinations (CT, PET-CT or EBUS).\n4. Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.\n5. Life expectancy is at least 12 weeks.\n6. At least 1 measurable lesion according to RECIST 1.1.\n7. With the feasiblility or anticipated feasiblility after neoadjuvant therapy to receive radical surgery;\n8. Patients with good function of other main organs (liver, kidney, blood system, etc.):\n\n   * ANC count ≥1.5×10\\^9\u002FL, platelet count ≥100×10\\^9\u002FL，hemoglobin ≥90 g\u002FL;\n   * the international standard ratio of prothrombin time (INR) and prothrombin time (PT) \\\u003C 1.5 times of upper limit of normal (ULN);\n   * Partial thromboplastin time (APTT) ≤1.5×ULN;\n   * Total bilirubin ≤1.5×ULN;\n   * Alanine aminotransferase (ALT) aspartate aminotransferase (AST) ≤2.5×ULN, or ALT and AST ≤5×ULN in the patients with liver metastatic tumor.\n9. Patients with normal lung function can tolerate surgery;\n10. Without systematic metastasis (including M1a, M1b and M1c);\n11. Fertile female patients must voluntarily use effective contraceptives not less than 120 days after chemotherapy or the last dose of Sintilimab (whichever is later) during the study period, and urine or serum pregnancy test results within 7 days prior to enrollment are negative.\n12. Unsterilized male patients must voluntarily use effective contraception during the study period not less than 120 days after chemotherapy or the last dose of Sintilimab (whichever is later).\n\nExclusion Criteria:\n\n1. Non-squamous cell carcinoma with EGFR active mutation positive or ALK rearrangement;\n2. 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;\n3. Administration of any Chinese medicine against cancer before administration of the drug;\n4. Participants with other cancer (excluding cervical carcinoma in situ, cured basal cell carcinoma, bladder epithelial tumor \\[including TA and tis\\]) within five years before the start of this study;\n5. 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;\n6. With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;\n7. Antibiotics were used to treat the infection for 4 weeks prior to the start of the trial;\n8. Participants who were systemically treated with corticosteroids (prednisone or other corticosteroids \\>10 mg\u002F day) or other immunosuppressive agents within 2 weeks prior to first administration. In the absence of active autoimmune disease, inhaled or topical corticosteroids and adrenal hormone replacement therapy with a dose of less than 10 mg\u002F day of prednisone are permitted;\n9. Participants who are allergic to the test drug or any auxiliary materials;\n10. Participants with active hepatitis B, hepatitis C or HIV;\n11. The vaccine was administered within 4 weeks of the start of the trial;\n12. Participants who have undergone major surgery or severe trauma in other systems within 2 months before the start of this trial;\n13. Pleural effusion, pericardial effusion or ascites that are not clinically controlled and require pleural puncture or abdominal puncture drainage within 2 weeks before inclusion;\n14. The patients have active pia meningioma, uncontrolled or untreated brain metastases;\n15. Pregnant or lactating women;\n16. Participants suffering from nervous system diseases or mental diseases that cannot cooperate;\n17. Participated in another therapeutic clinical study;\n18. Other factors that researchers think it is not suitable for enrollment.",{"count":461,"type":21},100,[24],"This is a phase II, non-randomized, open-label, multi-center study to evaluate the efficacy of neoadjuvant Sintilimab (PD-1 antibody) or combined with chemotherapy as first-line treatment in patients with stage III non-small cell lung cancer (NSCLC).",[27],"2023-09-10",{"date":467,"type":34},"2023-09-13",{"date":469,"type":34},"2022-09-10",{"date":471,"type":21},"2027-12-31",{"name":473,"class":41},"Shanghai Pulmonary Hospital, Shanghai, China",{"id":475,"slug":476,"hasResults":11,"nctId":477,"briefTitle":478,"officialTitle":479,"acronym":480,"eligibilityCriteria":481,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":482,"targetDuration":4,"studyType":22,"phases":484,"briefSummary":485,"conditions":486,"keywords":489,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":495,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":4},"100481400","phase-2-heterogeneously-hypofractionated-radiotherapy-for-locally-advanced-nsclc-100481400","NCT05548504","Heterogeneously Hypofractionated Radiotherapy for Locally Advanced NSCLC","HERAN2 Heterogeneously Hypofractionated Radiotherapy for Locally Advanced NSCLC A Randomised Multicentre Phase II Feasibility Study","HERAN2","Inclusion Criteria:\n\n* Histological or cytological confirmed LA\\_NSCLC\n* Not candidate for definitive chemo-radiotherapy\n* Performance status 0-2\n* Signed informed consent\n* Able to comply with study and follow-up procedures\n\nExclusion Criteria:\n\n* Prior radiotherapy to the thorax unless there is no significant overlap of current treatment volumes with previous treatment fields.\n* Uncontrolled other malignant disease.\n* Pregnancy",{"count":483,"type":21},182,[24],"Aim To test if proton therapy can improve survival compared to photon therapy in patients with locally advanced NSCLC who are not candidates for standard definitive chemo-radiotherapy.\n\nHypothesis The trial hypothesis is that proton therapy is less toxic than photon therapy in fragile patients and that this difference will mitigate to a difference in overall survival.\n\nDesign Multicentre, randomized phase II study 1:1 Sample size 182 patients (91 in each arm) Treatment Radiotherapy (inhomogeneous dose distribution) 50 Gy\u002F 24 fraction Endpoint Primary: Overall survival at 12 months Secondary: progression free survival, time to loco-regional and distant failure, pattern of failure, acute and late toxicity, quality of life, patient compliance.",[27,487,488],"Radiotherapy Side Effect","Frailty",[490,491,492,493,488],"Locally advanced NSCLC","Radiotherapy","Randomized","Photon>\u003Cproton therapy","2022-09-20",{"date":496,"type":34},"2022-09-21",{"date":498,"type":21},"2022-10-01",{"date":500,"type":21},"2029-09-30",{"name":502,"class":41},"Odense University Hospital",{"id":504,"slug":505,"hasResults":11,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":509,"eligibilityCriteria":510,"healthyVolunteers":11,"sex":17,"minAge":511,"maxAge":50,"enrollmentInfo":512,"targetDuration":4,"studyType":22,"phases":514,"briefSummary":515,"conditions":516,"keywords":519,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":525,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":531,"locationsCount":4},"100398271","phase-3-efficacy-and-safety-of-crt-durvalumab-and-surgery-for-sst-100398271","NCT04465968","Efficacy and Safety of CRT, Durvalumab and Surgery for SST","Efficacy and Safety of Durvalumab Before and After Operation or Durvalumab as Maintenance Therapy After Chemoradiotherapy Against Superior Sulcus Non-small Cell Lung Cancer","DEEP_OCEAN","Inclusion Criteria:\n\n1. A definite diagnosis of non-small cell lung cancer has been obtained by biopsy from the primary lesion.\n2. Meet all of the following (UICC-TNM classification 8th edition). I. Regarding the primary lesion, meet one of the following on chest CT. i. Direct invasion of the chest wall at or above the height of the first rib (at least invasion of the parietal pleura) ii. Direct invasion of the subclavian artery or vein II. Regarding regional lymph nodes, meet either of the following by chest CT and FDG-PET\u002FCT. Metastasis is also considered if lymph node metastasis is determined by either chest CT or FDG-PET\u002FCT.\n\n   i. cN0 ii. cN1 and no metastases to #10, #11, and #12 lymph nodes iii. cN3 (ipsilateral supraclavicular lymph node metastasis) and no metastases in regional lymph nodes (N1 and N2) other than \"#13, #14 lymph nodes\" III. No distant metastases (including intrapulmonary metastases in the same ling lobe and in a different lung lobe on the same side) on imaging tests including FDG-PET\u002FCT\n3. It is judged that radical resection is possible by lobectomy (including bilobectomy for 2 lobes), which satisfies the following \\[1\\] and \\[2\\].\n\n   I. The board respiratory surgeon judges that none of the following is true based on the image findings.\n\n   i. There is vertebral body infiltration that requires total spondylectomy ii. Presence of spinal cord infiltration iii. Invaded trachea or tracheal bifurcation iv. Invasion of aortic arch or ascending aorta v. Invading brachial plexus at C8 or higher vi. Esophageal infiltration that requires esophageal reconstruction for resection vii. Pneumonectomy is required for radical resection II. Meet all of the following. i. Predicted postoperative forced expiratory volume of 1 second (FEV1.0) ≥ 800 mL within 56 days before registration ii. SpO2 \\> 93% (room air) with the latest inspection value within 14 days before registration\n4. Consult with the radiotherapy doctor and it is judged that all of the following are met.\n\n   I. Radiation therapy is possible according to the protocol II. The irradiation field does not reach the hilum\n5. The age of the registration date is 20 years or older and 75 years or yonger.\n6. Performance status (PS) is 0 or 1 according to ECOG standards (PS must be described in medical records)\n7. The presence or absence of measurable lesions is not required.\n8. No history of following surgery irrespective of whether for a benign or malignant lesion.\n\n   I. Thoracoscopic surgery or thoracotomy with excision of the affected lung or esophagus or mediastinum (however, a history of thoracoscopic surgery without wedge resection or lung, esophagus, or mediastinal resection (eg, pleural biopsy)) is allowed) II. Median sternotomy surgery (with or without organ resection) III. Pulmonary resection other than wedge resection of the contralateral lung (whether open-heart surgery or thoracoscopic surgery)\n9. There is no history of chemotherapy, including treatment for other cancer types (including molecular targeted therapies and immune checkpoint inhibitors). However, the history of drug therapy as adjuvant therapy is allowed if it was completed more than 3 years ago. In addition, a history of hormone therapy for other cancer types is allowed.\n10. If there is a history of radiotherapy including other cancer types, the lung, hilum, mediastinum, and supraclavicular fossa are not included in the irradiation field.\n11. Chest CT does not show interstitial pneumonia or pulmonary fibrosis.\n12. No history of complication of autoimmune disease or chronic or recurrent autoimmune disease. However, patients with type 1 diabetes which is well controlled by appropriate treatment, hyperthyroidism\u002Fhypothyroidism that requires only antithyroid drug\u002Fhormone replacement therapy, autoimmune skin disease that does not require systemic treatment (Pemphigus, psoriasis vulgaris, pemphigus vulgaris, vitiligo), and celiac disease controlled only by dietary control are regarded as eligible if they have been inactive in the past 5 years, even with a history of autoimmune complications or history.\n13. No surgical treatment with general anesthesia within 14 days (2 weeks) before registration.\n14. No systemic administration of steroids, other immunosuppressive drugs, or immunoglobulins within 28 days (4 weeks) before registration. However, those that meet the following conditions are allowed.\n\n    I. Intranasal\u002Finhalation\u002Ftopical steroid injection or local steroid injection (for example, intra-articular injection) II. Systemic administration of steroid drugs at a dose of 10 mg\u002Fday or less in terms of prednisolone III. Steroids as premedication (eg CT premedication)\n15. Can be taken orally.\n16. No ischemic changes were observed on the latest 12-lead ECG within 28 days before registration. However, if a 12-lead electrocardiogram shows ischemic changes, echocardiography, exercise electrocardiography, etc. should be performed, and if it is judged that new treatment for ischemic heart disease is not necessary, it is qualified.\n17. The latest inspection value within 14 days before registration (possible on the same day two weeks before the registration date) satisfies all of the following.\n\n    I. White blood cell count ≧4,000\u002Fmm3 II. Hemoglobin ≥ 11.0 g\u002FdL (no blood transfusion within 14 days before the blood sampling date of the test used for registration) III. Platelet count ≧10×104 \u002Fmm3 IV. Total bilirubin ≤ 2.0 mg\u002FdL V. AST ≤ 75 U\u002FL VI. ALT ≤ 75 U\u002FL VII. Serum creatinine ≤ 1.2 mg\u002FdL\n18. Written informed consent from the patient to participate in the study.\n19. The attending physician can judge that the enrolled patients understand the treatment and evaluation schedule of this study and can comply with them.\n\nExclusion Criteria:\n\n1. Having active double cancer (simultaneous double cancer\u002Fmultiple cancer and metachronous double cancer\u002Fmultiple cancer with a disease-free period of 3 years or less, even if the disease-free period is less than 3 years, clinical The 5-year relative survival rate is similar to that of stage I prostate cancer, clinical stage 0 completely responded to radiation therapy, stage I laryngeal cancer, and complete excision of the following pathological stage cancers. History of cancer equivalent to 95% or more is not included in active double cancer\u002Fmultiple cancer). Gastric cancer \"adenocarcinoma (general type)\": Stage 0-I, colon cancer (adenocarcinoma): Stage 0-I, rectal cancer (adenocarcinoma): Stage 0-I, esophageal cancer (squamous cell carcinoma, glandular) Squamous cell carcinoma, basal cell carcinoma): Stage 0, breast cancer (non-invasive ductal carcinoma, lobular carcinoma): Stage 0, breast cancer (invasive ductal carcinoma, lobular invasive carcinoma, Paget's disease): 0 Stage-IIA, endometrial cancer (endometrioid adenocarcinoma, mucinous adenocarcinoma): Stage I, prostate cancer (adenocarcinoma): Stage I-II, cervical cancer (squamous cell carcinoma): Stage 0, thyroid cancer (Papillary cancer, follicular cancer): stage I, stage II, stage III, renal cancer (clear cell carcinoma, chromophobe cell carcinoma): stage I, non-melanoma skin cancer, malignant melanoma without a definite diagnosis, etc. Lesions of intramucosal cancer\n2. Has an infectious disease that requires systemic treatment (including active pulmonary tuberculosis).\n3. When registering, a fever of 38.0°C or higher is generated.\n4. Women who are pregnant, possibly pregnant, within 28 days of delivery, or breastfeeding. A man who wants a partner to become pregnant. Or a reproductive male or female patient who is not willing to use an effective contraceptive by Week 13 (Day 91) after the last dose of durvalumab (see 6.4.7.).\n5. Participation in the study is considered to be difficult due to the combination of mental illnesses or symptoms that impair daily life.\n6. Continuous systemic administration (oral or intravenous) of steroid drugs or other immunosuppressive drugs in excess of 10 mg\u002Fday in terms of prednisolone.\n7. With uncontrolled diabetes.\n8. With uncontrolled hypertension.\n9. A gastrointestinal disorder accompanied by uncontrolled diarrhea.\n10. With unstable angina (angina with onset or exacerbation of attack within the last 3 weeks) or a history of myocardial infarction within 6 months.\n11. Poor valvular heart disease, dilated cardiomyopathy, hypertrophic cardiomyopathy, congestive heart failure, and arrhythmia.\n12. Chest CT reveals severe emphysema.\n13. Either HBs antigen, HCV antibody, or HIV1\u002F2 antibody is positive.\n14. Continuous use of flucytosine (Ancotil®) is required.\n15. Participating in another clinical trial (excluding observational studies) during the 6 months prior to enrollment.\n16. A history of allogeneic organ transplant.\n17. A history of active primary immunodeficiency.\n18. Live vaccines (BCG, polio, measles-rubella mixture, measles, rubella, mumps, chickenpox, yellow fever, rotavirus, etc.) have been administered within 30 days before registration.\n19. Has hypersensitivity or allergy to the test drug or its additives used in this test.","20 Years",{"count":513,"type":21},84,[54],"The safety and efficacy of multimodality treatment of pre- and post-operative durvalumab therapy after pre-operative chemoradiotherapy for resectable superior sulcus tumor (SST) and durvalumab maintenance therapy after chemoradiotherapy for unresectable SST",[517,518,415],"Superior Sulcus Tumor","Non-small Cell Lung Cancer Stage IIB",[517,520,521,522,523,321],"Pancoast Tumor","Non-Small Cell Lung Cancer","Durvalumab","Multi-modality therapy","2020-07-07",{"date":526,"type":34},"2020-07-10",{"date":528,"type":21},"2020-09-01",{"date":530,"type":21},"2030-08-31",{"name":532,"class":41},"National Cancer Center Hospital East","Non-small Cell Lung Cancer, Stage III"]