Overview

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

Status:
Recruiting
Trial end date:
2024-09-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bristol-Myers Squibb
Treatments:
Carboplatin
Docetaxel
Nivolumab
Paclitaxel
Pemetrexed
Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com

Inclusion Criteria:

- Participants with suspected or histologically confirmed Stage IIA (> 4 cm) to IIIB
(T3N2) non-small cell lung carcinoma (NSCLC) with disease that is considered
resectable

- No brain metastasis

- Treatment-naive for NSCLC (no prior systemic anti-cancer treatment)

- Ability to provide surgical or biopsy tumor tissue for biomarkers

- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1

Exclusion Criteria:

- Participants with an active, known or suspected autoimmune disease

- Any positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency
virus (HIV)

- Any previous anti-cancer treatment including cytotoxic, IO treatment, targeted agents,
or radiotherapy for NSCLC

- Prior treatment with any anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody,
or any other antibody or drug specifically targeting T-cell co-stimulation or
checkpoint pathways

Other protocol-defined inclusion/exclusion criteria apply