drugset / Trial / NCT04026412

A Study of Nivolumab and Ipilimumab in Untreated Participants With Stage 3 Non-small Cell Lung Cancer (NSCLC) That is Unable or Not Planned to be Removed by Surgery

NCT04026412 ↗

Phase 3 Completed 925 enrolled Bristol-Myers Squibb
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary purpose of the study is to compare the effectiveness of nivolumab plus concurrent chemoradiotherapy (CCRT) followed by nivolumab plus ipilimumab vs CCRT followed by durvalumab in participants with untreated Locally Advanced Non-small Cell Lung Cancer (LA NSCLC).

Timeline

Start
2019-10-08
Primary completion
2024-03-22
Completion
2024-11-26

Outcome

Missed primary endpoint

paper At a median follow-up of 30.5 months, there was no statistically significant difference in the primary endpoint of PFS PMID 42129521 ↗

registry Arm A:Nivo + CCRT/Nivo + Ipi vs Arm C: CCRT/Durva; p = 0.6460 NCT04026412 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Durvalumab Monoclonal antibody — —
Subject Ipilimumab Monoclonal antibody — —
Subject Nivolumab Monoclonal antibody — —