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

  • STATUS
    Recruiting
  • End date
    Sep 30, 2024
  • participants needed
    452
  • sponsor
    Bristol-Myers Squibb
Updated on 15 September 2022
paclitaxel
carcinoma
metastasis
pemetrexed
carboplatin
brain metastases
docetaxel
nivolumab
cancer treatment
cancer chemotherapy
lung carcinoma

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.

Details
Condition Carcinoma, Non-Small-Cell Lung
Treatment cisplatin, docetaxel, carboplatin, Placebo, Paclitaxel, Pemetrexed, Nivolumab
Clinical Study IdentifierNCT04025879
SponsorBristol-Myers Squibb
Last Modified on15 September 2022

Eligibility

Yes No Not Sure

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
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