{"entity":{"id":"nct04025879","kind":"trial","name":"A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer","aka":["CheckMate 77T"],"tldr":"A phase 3 trial of Nivolumab, Carboplatin, Cisplatin, Pemetrexed and Docetaxel in non-small-cell lung cancer, run by Bristol-Myers Squibb, active and no longer recruiting.","summary":"A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer is a phase 3 interventional study registered as NCT04025879 by Bristol-Myers Squibb, with 461 participants enrolled, started 2019-11-05 and due to reach its primary completion in 2023-07-26. Interventions recorded: Nivolumab, Carboplatin, Cisplatin, Paclitaxel, Pemetrexed and Placebo. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04025879","url":"https://clinicaltrials.gov/study/NCT04025879"},{"label":"CheckMate 77T (New England Journal of Medicine 2024)","url":"https://doi.org/10.1056/NEJMoa2311926"},{"label":"NICE TA1127: nivolumab with chemotherapy neoadjuvant then alone adjuvant for resectable non-small-cell lung cancer","url":"https://www.nice.org.uk/guidance/ta1127"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["nivolumab","carboplatin","cisplatin","pemetrexed","docetaxel"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":["checkmate-816","keynote-671","nct03800134","neotorch","nct04379635"],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04025879-n-engl-j-med-2024"],"journals":[],"dependsOn":[],"notes":["CheckMate 77T was a phase 3 double-blind trial in adults with resectable stage IIA to IIIB non-small-cell lung cancer, randomised to four cycles of neoadjuvant nivolumab with chemotherapy or chemotherapy with placebo every three weeks, then surgery and up to thirteen cycles of adjuvant nivolumab or placebo every four weeks. At the prespecified interim analysis (median follow-up 25.4 months) the 18-month event-free survival rate was 70.2 percent against 50.0 percent (hazard ratio for progression, recurrence, abandoned surgery or death 0.58, 97.36 percent confidence interval 0.42 to 0.81). In the 68 Japanese patients, median event-free survival was not reached against 12.1 months (hazard ratio 0.46, 0.22 to 0.95), with pathological complete response 42.5 against 0 percent and major pathological response 52.5 against 7.1 percent (New England Journal of Medicine 2024; Cancer Science 2026)."],"nct":"NCT04025879","phase":"3","setting":"A Phase 3, Randomized, Double-blind Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Resection and Adjuvant Treatment With Nivolumab or Placebo for Participants With Resectable Stage II-IIIB Non-small Cell Lung Cancer","sponsor":"Bristol-Myers Squibb","result":"Eighteen-month event-free survival 70.2 percent with perioperative nivolumab against 50.0 percent with chemotherapy alone (hazard ratio 0.58, 97.36 percent confidence interval 0.42 to 0.81).","started":"2019-11-05","startedType":"actual","yearReported":2024,"enrolled":461,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-Free Survival (EFS) by BICR","primary":true,"unit":"months","arms":[{"name":"Nivolumab + SOC Chemotherapy","n":229,"note":"Insufficient number of participants with events; Figures from the ClinicalTrials.gov results section (first posted 2024-07-23), not from a publication"},{"name":"Placebo + SOC Chemotherapy","n":232,"value":18.43,"note":"95% CI 13.63 to 28.06"}],"p":"0.00025","source":"https://clinicaltrials.gov/study/NCT04025879?tab=results"}],"replication":"AEGEAN, KEYNOTE-671, Neotorch and RATIONALE-315 all found the same direction of effect with the same perioperative design."},"route":"/trials/nct04025879/","neighbours":{"cancer":[{"id":"lung-cancer","kind":"cancer","name":"Lung cancer (all types)","route":"/cancers/lung-cancer/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"resectable-nsclc","kind":"cancer","name":"Resectable stage I to III non-small-cell lung cancer","route":"/cancers/resectable-nsclc/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"drug":[{"id":"carboplatin","kind":"drug","name":"Carboplatin","route":"/drugs/carboplatin/"},{"id":"cisplatin","kind":"drug","name":"Cisplatin","route":"/drugs/cisplatin/"},{"id":"docetaxel","kind":"drug","name":"Docetaxel","route":"/drugs/docetaxel/"},{"id":"nivolumab","kind":"drug","name":"Nivolumab","route":"/drugs/nivolumab/"},{"id":"pemetrexed","kind":"drug","name":"Pemetrexed","route":"/drugs/pemetrexed/"}],"company":[{"id":"bms","kind":"company","name":"Bristol Myers Squibb","route":"/companies/bms/"}],"trial":[{"id":"nct03800134","kind":"trial","name":"A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer","route":"/trials/nct03800134/"},{"id":"checkmate-816","kind":"trial","name":"CheckMate 816","route":"/trials/checkmate-816/"},{"id":"nct04379635","kind":"trial","name":"Comparing the Efficacy and Safety of a New Additional Treatment With Tislelizumab in Non-Small Cell Lung Cancer (NSCLC)","route":"/trials/nct04379635/"},{"id":"keynote-671","kind":"trial","name":"KEYNOTE-671","route":"/trials/keynote-671/"},{"id":"neotorch","kind":"trial","name":"Neotorch","route":"/trials/neotorch/"}],"paper":[{"id":"paper-nct04025879-n-engl-j-med-2024","kind":"paper","name":"Perioperative Nivolumab in Resectable Lung Cancer","route":"/key-papers/paper-nct04025879-n-engl-j-med-2024/"}]}}