NCT04025879

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 461 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of the study is to examine if periadjuvant (neoadjuvant, then adjuvant) immunotherapy will prolong event free survival in participants with early stage non-small cell lung cancer.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
BIOLOGICAL	Nivolumab	Specified dose on specified days
DRUG	Carboplatin	Specified dose on specified days
DRUG	Cisplatin	Specified dose on specified days
DRUG	Paclitaxel	Specified dose on specified days
DRUG	Pemetrexed	Specified dose on specified days
DRUG	Placebo	Specified dose on specified days
DRUG	Docetaxel	Specified dose on specified days

Timeline

• Start date: 2019-11-05
• Primary completion: 2023-07-26
• Completion: 2027-07-30
• First posted: 2019-07-19
• Last updated: 2025-10-16
• Results posted: 2024-07-23

Locations

108 sites across 22 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, China, Czechia, France, Germany, Ireland, Italy, Japan, Mexico, Netherlands, Poland, Puerto Rico, Romania, Russia, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study