CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 367 enrolled
Drug / intervention
Nivolumab +4 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02864251
NCT02864251Phase 3Completed

Open-Label, Randomized Trial of Nivolumab (BMS-936558) Plus Pemetrexed/Platinum or Nivolumab Plus Ipilimumab (BMS-734016) vs Pemetrexed Plus Platinum in Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) Subjects With Epidermal Growth Factor Receptor (EGFR) Mutation Who Failed 1L or 2L EGFR Tyrosine Kinase Inhibitor Therapy

Bristol-Myers Squibb·interventional·Posted Aug 11, 2016·Updated Sep 28, 2023

In Brief

A Phase 3 clinical trial evaluating Nivolumab, Ipilimumab, and 3 other interventions for Non-Small-Cell Lung Carcinoma. Completed, enrolled 367 participants across 109 sites in 10 countries.

Detailed Summary

The main purpose of this study is to determine whether nivolumab + chemotherapy is effective as compared to chemotherapy in the treatment of patients with EGFR mutation, NSCLC who failed first line (1L) or second-line (2L) EGFR TKI therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, China, France, Hong Kong, Japan, Singapore, South Korea, Spain, Taiwan, United States

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 11, 2016
Enrollment StartMar 17, 2017
Primary CompletionJan 20, 2022
Study CompletionOct 17, 2022
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 9.9 years ago

Interventions

Nivolumabbiological

Specified dose on specified days

Ipilimumabbiological

Specified dose on specified days

Pemetrexeddrug

Specified dose on specified days

Cisplatindrug

Specified dose on specified days

Carboplatindrug

Specified dose on specified days