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

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

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.

Trial Description

Primary Outcome:

• Event-Free Survival (EFS) as Assessed by Blinded Independent Central Review (BICR)

• Overall Survival (OS)
• Pathologic Complete Response (pCR) Rate as Assessed by Blinded Independent Pathology Review (BIPR)
• Major Pathological Response (MPR) Rate as Assessed by Blinded Independent Pathology Review
• Incidence of Serious Adverse Events (SAEs)
• Incidence of Adverse Events (AEs)

View this trial on ClinicalTrials.gov