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Trial ID CA245-0001  |   NCT06646276

A Study to Compare the Efficacy and Safety of BMS-986489 (BMS-986012+ Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide to That of Atezolizumab With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS).

Summary

  • Phase 3
  • Male and Female Gender icon
  • 18+
    Age Range
  • 100
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

The Purpose of the Study is to Compare the Efficacy and Safety of BMS-986489 (Anti-fucosyl-GM1+ Nivolumab Fixed Dose Combination) in Combination with Carboplatin plus Etoposide to that of Atezolizumab with Carboplatin plus Etoposide as First-Line Therapy in Participants with Extensive-Stage Small Cell Lung Cancer.

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • Participants must have diagnosis of Extensive-Stage Small Cell Lung Cancer (ES-SCLC).
    1. Participants must be Healthy enough to do their normal activities with little or no help based on the ECOG performance scale.
      1. Participants must have at least one tumor that can be measured using special imaging techniques like a CT scan or MRI at a site other than the brain and nervous system

        Exclusion Criteria

        Exclusion Criteria Icon
        :
        • Participants have already received certain types of treatment for extensive stage small cell lung cancer
          1. Participants have certain health conditions, like spread of small cell lung cancer to the brain that are causing symptoms, certain lung diseases, heart diseases, infections, autoimmune diseases, other cancers, or a type of nerve damage called peripheral sensory neuropathy
            Additional Information *
            • Other protocol-defined Inclusion/Exclusion criteria apply.

              Treatment Options

              Study Arms

              ASSIGNED INTERVENTION

              Study Arms

              Experimental: Arm A

              ASSIGNED INTERVENTION
              • Biological: BMS-986489 (BMS-986012+Nivolumab)
              • Drug: Carboplatin, Etoposide

              Study Arms

              Active Comparator: Arm B

              ASSIGNED INTERVENTION
              • Biological: Atezolizumab
              • Drug: Carboplatin, Etoposide
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