CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,747 enrolled
Drug / intervention
Nivolumab +6 moredrug
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Histologically confirmed Stage IV or recurrent NSCLC (squamous or non-squamous)
  • ✓Chemotherapy-naïve (no prior systemic anticancer therapy)
  • ✓PD-L1 immunohistochemical testing with results performed by central lab
  • ✓Measurable disease by CT or MRI per RECIST 1.1
Key exclusion· 3
  • ✕Untreated CNS metastases
  • ✕Active, known, or suspected autoimmune disease
  • ✕Positive test for hepatitis B, hepatitis C, or HIV indicating acute or chronic infection

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

Search/NCT02477826
NCT02477826Phase 3Completed
CompareCT.gov

An Open-Label, Randomized Phase 3 Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Subjects With Chemotherapy-Naïve Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

Bristol-Myers Squibb·interventional·Posted Jun 23, 2015·Updated Oct 30, 2025

In Brief

A Phase 3 clinical trial evaluating Nivolumab, Ipilimumab, and 5 other interventions for Non-Small Cell Lung Cancer. Completed, enrolled 2,747 participants across 290 sites in 33 countries.

Detailed Summary

The purpose of this study is to show that Nivolumab, or Nivolumab plus Ipilimumab, or Nivolumab plus Platinum-Doublet Chemotherapy improves progression free survival and/or overall survival compared with chemotherapy in patients with advanced lung cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small Cell Lung Cancer
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Lebanon, Mexico, Netherlands, Peru, Poland, Romania, Russia, South Africa, South Korea, Spain, Switzerland, Taiwan, United Kingdom, United States
CollaboratorsOno Pharmaceutical Co., Ltd.

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 23, 2015
Enrollment StartAug 5, 2015
Primary CompletionOct 25, 2024
TodayJul 2, 2026
Enrollment to primary: 9.2 yearsPosted 11.0 years ago

Interventions

Nivolumabdrug

Ipilimumabdrug

Carboplatindrug

Cisplatindrug

Gemcitabinedrug

Pemetrexeddrug

Paclitaxeldrug