{"entity":{"id":"nct03391869","kind":"trial","name":"Nivolumab and Ipilimumab With or Without Local Consolidation Therapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer","aka":["LONESTAR"],"tldr":"A phase 3 trial of ipilimumab and nivolumab in lung cancer, run by M.D. Anderson Cancer Center, active but no longer recruiting.","summary":"Nivolumab and Ipilimumab With or Without Local Consolidation Therapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer is a phase 3, randomised interventional study registered as NCT03391869 by M.D. Anderson Cancer Center, with a registry enrolment figure of 339 participants, started 2017-12-29 and due to reach its primary completion in 2027-03-31. Interventions recorded: Ipilimumab; Local Consolidation Therapy; Nivolumab; Quality-of-Life Assessment; Radiation Therapy; Therapeutic Conventional Surgery. Conditions listed: Lung Adenocarcinoma; Lung Non-Small Cell Carcinoma; Stage IV Lung Cancer AJCC v8. Primary outcome: Overall survival (OS) in overall population; OS in oligometastatic subgroup. Lung eligibility wording from the registry: \"* Histologically or cytologically confirmed non-small cell lung cancer; if a diagnostic biopsy is available, a pre-treatment biopsy is not required\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT03391869","url":"https://clinicaltrials.gov/study/NCT03391869"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["lung-adenocarcinoma"],"sections":[],"technologies":["checkpoint-inhibitor","imrt-igrt"],"targets":[],"drugs":["ipilimumab","nivolumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03391869","phase":"3","setting":"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)","sponsor":"M.D. Anderson Cancer Center","participation":[{"nct":"NCT03391869","source":"https://clinicaltrials.gov/study/NCT03391869","fetchedAt":"2026-10-07T16:53:01.545Z","studySha256":"3637c801596cb5146da0412101ef61e87b8db31df3fbbf9d4530f84f42b61feb","overallStatus":"ACTIVE_NOT_RECRUITING","lastUpdatePosted":"2026-09-18","leadSponsor":"M.D. Anderson Cancer Center","collaboratorCount":0,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":339,"enrolmentType":"ACTUAL","siteCount":5,"recruitingSiteCount":0,"countries":["United States"]}],"started":"2017-12-29","startedType":"actual","enrolled":339,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct03391869/","neighbours":{"cancer":[{"id":"lung-adenocarcinoma","kind":"cancer","name":"Adenocarcinoma of the lung","route":"/cancers/lung-adenocarcinoma/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"},{"id":"imrt-igrt","kind":"technology","name":"IMRT / IGRT (modern external beam)","route":"/technologies/imrt-igrt/"}],"drug":[{"id":"ipilimumab","kind":"drug","name":"Ipilimumab","route":"/drugs/ipilimumab/"},{"id":"nivolumab","kind":"drug","name":"Nivolumab","route":"/drugs/nivolumab/"}],"term":[{"id":"lung-trials-open-today","kind":"term","name":"Lung cancer trials open today (registry snapshot)","route":"/terms/lung-trials-open-today/"}]}}