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Trial ID CA209-77T  |   NCT04025879

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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Summary

  • Phase 3
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

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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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • Participants with suspected or histologically confirmed Stage IIA (> 4
    1. to IIIB (T3N2) non-small cell lung carcinoma (NSCLC) with disease that is considered resectable
    2. No brain metastasis
      1. Treatment-naive for NSCLC (no prior systemic anti-cancer treatment)
        1. Ability to provide surgical or biopsy tumor tissue for biomarkers
          1. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1

            Exclusion Criteria

            Exclusion Criteria Icon
            :
            • Participants with an active, known or suspected autoimmune disease
              1. Any positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV)
                1. Any previous anti-cancer treatment including cytotoxic, IO treatment, targeted agents, or radiotherapy for NSCLC
                  1. 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
                    Additional Information *

                    Treatment Options

                    Study Arms

                    ASSIGNED INTERVENTION

                    Study Arms

                    Experimental: Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo

                    ASSIGNED INTERVENTION
                    • Biological: Nivolumab
                    • Drug: Carboplatin, Cisplatin, Paclitaxel, Pemetrexed, Docetaxel

                    Study Arms

                    Placebo Comparator: Neoadj. Plac. + Pt-based Doublet Chemo followed by Adj.Plac.

                    ASSIGNED INTERVENTION
                    • Drug: Carboplatin, Cisplatin, Paclitaxel, Pemetrexed, Placebo, Docetaxel

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