Clinical Trial: 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
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 3| Lead Sponsor: | Bristol-Myers Squibb |
| Information Provided By: | Bristol-Myers Squibb |
| Last Update Posted: | 2026-08-26 |
Study Overview
Brief 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.
Official Title
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
Conditions
Carcinoma, Non-Small-Cell Lung
Intervention / Treatment
- Biological: Nivolumab
- Drug: Carboplatin
- Drug: Cisplatin
- Drug: Paclitaxel
- Drug: Pemetrexed
- Drug: Placebo
- Drug: Docetaxel
Other Study ID Numbers
- CA209-77T
- 2019-000262-38
- 2019
Start Date (Actual)
2019-11-05
Primary Completion Date (Actual)
2023-07-26
Study Completion Date (Estimated)
2027-07-31
Enrollment (Actual)
461
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Bristol-Myers Squibb |
| Information Provided By: | Bristol-Myers Squibb |
| Last Update Posted: | 2026-08-26 |
Study Overview
Brief 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.
Official Title
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
Conditions
Carcinoma, Non-Small-Cell Lung
Intervention / Treatment
- Biological: Nivolumab
- Drug: Carboplatin
- Drug: Cisplatin
- Drug: Paclitaxel
- Drug: Pemetrexed
- Drug: Placebo
- Drug: Docetaxel
Other Study ID Numbers
- CA209-77T
- 2019-000262-38
- 2019
Start Date (Actual)
2019-11-05
Primary Completion Date (Actual)
2023-07-26
Study Completion Date (Estimated)
2027-07-31
Enrollment (Actual)
461
Study Type
Interventional
Phase
Phase 3