{"preliminary_commentary":{"by_channel":{"x_thread":18,"youtube":5,"podcast":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT03391869\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"name":"NCT03391869","nct_id":"NCT03391869","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct03391869. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"INDUCTION PHASE: Patients receive nivolumab IV over 90 minutes on days 1, 15, and 29, and ipilimumab IV over 60 minutes on day 1. Treatment repeats every 6 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.\n\nPatients receive nivolumab IV over 60 minutes on days 1, 15, and 29 and ipilimumab IV over 90 minutes on day 1. Courses repeat every 6 weeks for 2 years in the absence of disease progression or unacceptable toxicity.","label":"Arm A (ipilimumab, nivolumab)","type":"EXPERIMENTAL"},{"description":"INDUCTION PHASE: Patients receive nivolumab IV over 90 minutes on days 1, 15, and 29, and ipilimumab IV over 60 minutes on day 1. Treatment repeats every 6 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.\n\nPatients receive LCT consisting of surgery and/or radiation 14 days after completion of Induction Phase. Patients then receive nivolumab and ipilimumab as in arm A beginning within 4 weeks after LCT. Courses repeat every 6 weeks for 2 years in the absence of disease progression or unacceptable toxicity.","label":"Arm B (ipilimumab, nivolumab, LCT)","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2027-03-31","type":"ESTIMATED"},"conditions":["Lung Adenocarcinoma","Lung Non-Small Cell Carcinoma","Stage IV Lung Cancer AJCC v8"],"enrollment":{"count":339,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Ipilimumab","otherNames":["Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody","BMS-734016","Ipilimumab Biosimilar CS1002","MDX-010","MDX-CTLA4","Yervoy"],"type":"BIOLOGICAL"},{"name":"Local Consolidation Therapy","otherNames":["LCT","Local Consolidative Therapy"],"type":"PROCEDURE"},{"name":"Nivolumab","otherNames":["BMS-936558","MDX-1106","NIVO","ONO-4538","Opdivo"],"type":"BIOLOGICAL"},{"name":"Quality-of-Life Assessment","otherNames":["Quality of Life Assessment"],"type":"OTHER"},{"name":"Radiation Therapy","otherNames":["Cancer Radiotherapy","ENERGY_TYPE","Irradiate","Irradiated","Irradiation","Radiation","Radiation Therapy, NOS","Radiotherapeutics","Radiotherapy","RT","Therapy, Radiation"],"type":"RADIATION"},{"name":"Therapeutic Conventional Surgery","otherNames":[],"type":"PROCEDURE"}],"last_update":"2026-09-18","lead_sponsor":"M.D. Anderson Cancer Center","official_title":"Randomized Phase III Trial of Local Consolidation Therapy (LCT) After Nivolumab and Ipilimumab for Immunotherapy-Naive Patients With Metastatic Non-Small Cell Lung Cancer (LONESTAR)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2027-03-31","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Overall survival (OS) in overall population","timeFrame":"Up to 1 year after completion of study treatment"},{"measure":"OS in oligometastatic subgroup","timeFrame":"Up to 1 year after completion of study treatment"}],"references":[{"citation":"Altan M, Li R, Li Z, Chen R, Sheshadri A, Tran HT, Little L, Baguley J, Sinson J, Vokes N, Gandhi S, Antonoff MB, Swisher SG, Lizee G, Reuben A, Heymach JV, Zhang J. High peripheral T cell diversity is associated with lower risk of toxicity and superior response to dual immune checkpoint inhibitor therapy in patients with metastatic NSCLC. J Immunother Cancer. 2024 Dec 25;12(12):e008950. doi: 10.1136/jitc-2024-008950.","pmid":"39721752","type":"DERIVED"},{"citation":"Altan M, Li QZ, Wang Q, Vokes NI, Sheshadri A, Gao J, Zhu C, Tran HT, Gandhi S, Antonoff MB, Swisher S, Wang J, Byers LA, Abdel-Wahab N, Franco-Vega MC, Wang Y, Lee JJ, Zhang J, Heymach JV. Distinct patterns of auto-reactive antibodies associated with organ-specific immune-related adverse events. Front Immunol. 2023 Dec 12;14:1322818. doi: 10.3389/fimmu.2023.1322818. eCollection 2023.","pmid":"38152395","type":"DERIVED"}],"start_date":{"date":"2017-12-29","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Nivolumab and Ipilimumab With or Without Local Consolidation Therapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer","url":"https://clinicaltrials.gov/study/NCT03391869"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct03391869"}