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Active, Not Recruiting

A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC) - CA209-816

Updated: 12 October, 2023   |   ClinicalTrials.gov

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CONSIDERING THIS TRIAL?
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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

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Nivolumab plus Ipilimumab
Biological: Nivolumab, Ipilimumab
Experimental: Nivolumab plus platinum doublet chemotherapy
Biological: Nivolumab Drug: Cisplatin, Gemcitabine, Pemetrexed, Carboplatin, Paclitaxel
Active Comparator: Platinum doublet chemotherapy
Drug: Cisplatin, Vinorelbine, Gemcitabine, Docetaxel, Pemetrexed, Carboplatin, Paclitaxel

Key Eligibility Criteria

Inclusion Criteria: - Early stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue - Lung function capacity capable of tolerating the proposed lung surgery - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 - Available tissue of primary lung tumor Exclusion Criteria: - Presence of locally advanced, inoperable or metastatic disease - Participants with active, known or suspected autoimmune disease - Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors) Other protocol defined inclusion/exclusion criteria apply

If you want to report a side effect, you can report directly to the Danish Medicines Agency via the website www.meldenbivirkning.dk
We recommend that you also contact BMS to report side effects.
Side effects and other reportable events are defined here
Report side effects or product quality complaints: Medical Information

466-DK-2200001