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

Protocol # :
Carcinoma, Non-Small-Cell Lung
Disease Sites
Principal Investigator
Awad, Mark
Site Investigator
Dagogo-Jack, Ibiayi
Wee, Jon, O.
Site Research Nurses
Burke, Millicent
Kuberski, Heather, D.
Lam, Ethan
Souza, Joseph
Stober, Lisa, L.
Sullivan, Molly, O'Brien
Wanat, Alexandra

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

- 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