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
Purpose
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.
Condition
- Carcinoma, Non-Small-Cell Lung
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo |
|
|
|
Placebo Comparator Neoadj. Plac. + Pt-based Doublet Chemo followed by Adj.Plac. |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- Bristol-Myers Squibb