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
Trial Description
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.
Eligibility Requirements
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