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

A Phase 3, Randomized, Open Label Study to Compare Nivolumab Plus Concurrent Chemoradiotherapy (CCRT) Followed by Nivolumab Plus Ipilimumab or Nivolumab Plus CCRT Followed by Nivolumab vs CCRT Followed by Durvalumab in Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 925 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Non-Small Cell Lung Cancer (NSCLC)

Interventions

Type	Name	Description
BIOLOGICAL	nivolumab	Specified dose on specified days
BIOLOGICAL	ipilimumab	Specified dose on specified days
BIOLOGICAL	durvalumab	Specified dose on specified days

Timeline

• Start date: 2019-10-08
• Primary completion: 2024-03-22
• Completion: 2024-11-26
• First posted: 2019-07-19
• Last updated: 2025-07-24
• Results posted: 2025-07-24

Locations

183 sites across 27 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, France, Germany, Greece, Ireland, Italy, Japan, Mexico, Netherlands, Poland, Puerto Rico, Romania, Russia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study