[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07149363":3,"trial-entities:NCT07149363":131,"trial-summary:NCT07149363":135},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":37,"secondary_outcomes":42,"sex":54,"minimum_age":55,"maximum_age":56,"healthy_volunteers":57,"eligibility_criteria":58,"std_ages":83,"locations":86,"central_contacts":112,"overall_officials":118,"references":129,"see_also_links":130},"NCT07149363","AFT-61","Adjuvant Chemotherapy and Immunotherapy for Completely Resected Small Cell Lung Cancer","RECRUITING","2031-02","2026-06","2026-06-26","2026-02-12","Alliance Foundation Trials, LLC.","OTHER",true,"This is a phase II trial of adjuvant chemotherapy and immunotherapy for completely resected small cell lung cancer (SCLC).","This is a phase II open-label, single-arm, multi-center study to evaluate the efficacy and safety of adjuvant immunotherapy with chemotherapy for completely resected pathologic T1-T2, N0-N1, M0 small cell lung cancer (SCLC). The statistical design includes a predefined range of alpha and power to detect an improvement in 2-year disease free survival (DFS).",[18],"Small Cell Lung Cancer (SCLC)",[],"INTERVENTIONAL","TREATMENT",[23],"PHASE2",{"count":25,"type":26},65,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":34},"DRUG","Durvalumab 50 MG\u002FML","Following surgical removal of their small-cell lung cancer, participants will receive a combination of 1500 mg durvalumab and cisplatin 75 mg\u002Fm2 or carboplatin AUC 5 on day 1, and etoposide 100 mg\u002Fm2 on days 1, 2, and 3, every 3 weeks for 4 cycles (a total of 12 weeks). Following the combination of chemotherapy and immunotherapy, participants will then receive 1500 mg durvalumab every 4 weeks for 9 cycles (a total of 36 weeks).",[33],"Durvalumab and one of the two chemotherapy combinations: cisplatin or carboplatin, and etoposide",[35,36],"Imfinzi®","MEDI4736",[38],{"measure":39,"description":40,"timeFrame":41},"Disease free survival (DFS)","To determine whether the addition of durvalumab to adjuvant chemotherapy after surgery for limited-stage SCLC leads to improved disease free survival (DFS) when compared to historical data of participants who received adjuvant chemotherapy without immunotherapy after surgery for SCLC. DFS is measured in months from the time of surgery.","2 years",[43,47,51],{"measure":44,"description":45,"timeFrame":46},"Overall survival (OS)","To determine whether the addition of durvalumab to adjuvant chemotherapy after surgery for limited-stage SCLC leads to improved overall survival (OS) when compared to historical data of participants who received adjuvant chemotherapy without immunotherapy after surgery for SCLC. OS is measured in months from the time of surgery.","3 years",{"measure":48,"description":49,"timeFrame":50},"Safety of the regimen","The frequency of grade 3+ treatment-related adverse events will be reported.","1 year",{"measure":48,"description":52,"timeFrame":53},"The frequency of grade 3+ all-cause adverse events will be reported.","5 years","ALL","18 Years",null,false,{"inclusion":59,"exclusion":69,"raw_text":82},[60,61,62,63,64,65,66,67,68],"Age ≥ 18 years.","Body weight \\>30 kg.","Must have a life expectancy of at least 12 weeks.","Must have histologically or cytologically confirmed diagnosis of pathologic T1-T2 N0-1 M0 small-cell lung cancer per the American Joint Committee on Cancer staging system, 8th edition.","Have completely resected (wedge resection, segmentectomy, lobectomy, sleeve lobectomy, bilobectomy, or pneumonectomy) small-cell lung cancer within 78 days of enrollment.","Complete mediastinal lymph node dissection (MLND) or systematic mediastinal lymph node sampling is required.","No prior systemic therapies, for small cell lung cancer.","Post-operative radiation for the resected small cell lung cancer is acceptable per treating physician in the setting of N1 disease, but no other prior radiation for small cell lung cancer.","ECOG performance status 0-1.",[70,71,72,73,74,75,76,77,78,79,80,81],"Patients who are receiving any other investigational agents.","Concurrent enrollment in another clinical study involving investigational treatment directed to treatment of patients with small cell lung cancer.","Prior treatment with durvalumab.","History of another primary malignancy except for:","Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of IP and of low potential risk for recurrence.","Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.","Superficial bladder cancer without active disease after treatment.","Low grade prostate cancer without indication for active treatment.","Adequately treated carcinoma in situ without evidence of disease.","Patients with a history of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or insufficiently treated deep venous thrombosis (DVT) within the past 3 months.","Patients with hemoptysis in excess of 2.5 mL within 2 weeks prior to the first dose of study medication.","Patients requiring concomitant therapy with phenytoin, phenobarbital, or carbamazepine.","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Body weight \\>30 kg.\n* Must have a life expectancy of at least 12 weeks.\n* Must have histologically or cytologically confirmed diagnosis of pathologic T1-T2 N0-1 M0 small-cell lung cancer per the American Joint Committee on Cancer staging system, 8th edition.\n* Have completely resected (wedge resection, segmentectomy, lobectomy, sleeve lobectomy, bilobectomy, or pneumonectomy) small-cell lung cancer within 78 days of enrollment.\n* Complete mediastinal lymph node dissection (MLND) or systematic mediastinal lymph node sampling is required.\n* No prior systemic therapies, for small cell lung cancer.\n* Post-operative radiation for the resected small cell lung cancer is acceptable per treating physician in the setting of N1 disease, but no other prior radiation for small cell lung cancer.\n* ECOG performance status 0-1.\n\nExclusion Criteria:\n\n* Patients who are receiving any other investigational agents.\n* Concurrent enrollment in another clinical study involving investigational treatment directed to treatment of patients with small cell lung cancer.\n* Prior treatment with durvalumab.\n* History of another primary malignancy except for:\n\n  * Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of IP and of low potential risk for recurrence.\n  * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.\n  * Superficial bladder cancer without active disease after treatment.\n  * Low grade prostate cancer without indication for active treatment.\n  * Adequately treated carcinoma in situ without evidence of disease.\n* Patients with a history of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or insufficiently treated deep venous thrombosis (DVT) within the past 3 months.\n* Patients with hemoptysis in excess of 2.5 mL within 2 weeks prior to the first dose of study medication.\n* Patients requiring concomitant therapy with phenytoin, phenobarbital, or carbamazepine.",[84,85],"ADULT","OLDER_ADULT",[87,96,104],{"facility":88,"status":7,"city":89,"state":90,"zip":91,"country":92,"geoPoint":93},"University of Illinois Chicago","Chicago","Illinois","60612","United States",{"lat":94,"lon":95},41.85003,-87.65005,{"facility":97,"status":7,"city":98,"state":99,"zip":100,"country":92,"geoPoint":101},"Dana Farber Cancer Institute","Boston","Massachusetts","02215",{"lat":102,"lon":103},42.35843,-71.05977,{"facility":105,"status":7,"city":106,"state":107,"zip":108,"country":92,"geoPoint":109},"University of Virginia Comprehensive Cancer Center","Charlottesville","Virginia","22908",{"lat":110,"lon":111},38.02931,-78.47668,[113],{"name":114,"role":115,"phone":116,"email":117},"Quality Management and Compliance","CONTACT","617-732-8727","ClinicalTrials.Queries@alliancefoundationtrials.org",[119,123,126],{"name":120,"affiliation":121,"role":122},"Chi-Fu Jeffrey Yang, MD","Massachusetts General Hospital","STUDY_CHAIR",{"name":124,"affiliation":125,"role":122},"Jacob Sands, MD","Dana-Farber Cancer Institute",{"name":127,"affiliation":12,"role":128},"Evanthia Galanis, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":132,"biomarkers":134},[133],"Lung Small Cell Carcinoma",[],{"nct_id":4,"found":14,"summary":136,"prompt_version":146},{"design":137,"status":138,"heading":139,"summary":140,"follow_up":141,"word_count":142,"commitments":143,"compensation":144,"drugs_mentioned":145},"This is a Phase II, open-label, single-arm study, meaning all participants will receive the same treatment and both you and your doctors will know what treatment you are getting. It plans to enroll 65 participants.","completed","Adjuvant Chemotherapy and Immunotherapy for Small Cell Lung Cancer","This study is testing a combination of chemotherapy and immunotherapy (Durvalumab) after surgery for small cell lung cancer (SCLC). You might be able to join if you are at least 18 years old, have a life expectancy of at least 12 weeks, and have had your SCLC completely removed by surgery. The researchers want to see if this treatment can help people stay disease-free for at least two years after treatment. The current recruitment status for this study is unclear.","The study will measure how long participants remain disease-free for at least two years after treatment.",80,"Participants will receive Durvalumab along with cisplatin or carboplatin, and etoposide every three weeks for a total of 12 weeks (4 cycles).","Not stated in the trial record.",[],"v2"]