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Trial ID CA239-0013  |   NCT04685135

Phase 3 Study of MRTX849 (Adagrasib) vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation

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Sorry, this study is no longer accepting new participants, but is still ongoing.
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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

This Phase 3 study will evaluate the efficacy of the investigational agent MRTX849 (adagrasib) versus docetaxel in patients who have been previously treated for metastatic NSCLC with a KRAS G12C mutation.

Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • Histologically or cytologically confirmed diagnosis of NSCLC with KRAS G12C mutation.
    1. Candidacy to receive treatment with docetaxel. Crossover Inclusion Criteria:
      1. Evidence of RECIST 1.1 defined disease progression on docetaxel per BICR
        1. ECOG performance status 0-2

          Exclusion Criteria

          Exclusion Criteria Icon
          :
          • Prior treatment with an agent targeting KRAS G12C (e.g., AMG 510, Sotorasib).
            1. Active brain metastases. Crossover Exclusion Criteria:
              1. Receipt of any other systemic anti-cancer therapy after last administration of docetaxel on the study.
                Additional Information *

                Treatment Options

                Study Arms

                ASSIGNED INTERVENTION

                Study Arms

                Active Comparator: Docetaxel

                ASSIGNED INTERVENTION
                • Drug: Docetaxel

                Study Arms

                Experimental: MRTX849

                ASSIGNED INTERVENTION
                • Drug: MRTX849

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