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Recruiting

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 - CA209-77T

Updated: 19 November, 2021   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 3

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 69

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo
Drug: Docetaxel Drug: Cisplatin Drug: Pemetrexed Biological: Nivolumab Drug: Carboplatin Drug: Paclitaxel
Placebo Comparator: Neoadj. Plac. + Pt-based Doublet Chemo followed by Adj.Plac.
Drug: Docetaxel Drug: Carboplatin Drug: Placebo Drug: Paclitaxel Drug: Pemetrexed Drug: Cisplatin

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com