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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. 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
  2. No brain metastasis
  3. Treatment-naive for NSCLC (no prior systemic anti-cancer treatment)
  4. Ability to provide surgical or biopsy tumor tissue for biomarkers
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1

EXCLUSION CRITERIA

Exclusion Criteria:


  1. Participants with an active, known or suspected autoimmune disease
  2. Any positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV)
  3. Any previous anti-cancer treatment including cytotoxic, IO treatment, targeted agents, or radiotherapy for NSCLC
  4. 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


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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study Details


Contition
Carcinoma, Non-Small-Cell Lung
Age (in years)
18+
Phase
PHASE3
Participants Needed
461
Est. Completion Date
Jul 30, 2027
Treatment Type
INTERVENTIONAL

Sponsor
Bristol-Myers Squibb
ClinicalTrials.gov NCT Identifier
NCT04025879
Study Number
CA20977T

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