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Clinical Trials/EUCTR2020-003645-11-CZ
EUCTR2020-003645-11-CZActive, not recruitingPhase 1

A Randomized Phase 3 Study of MRTX849 Versus Docetaxel in Patients With Previously Treated Non-Small Cell Lung Cancer With KRAS G12C Mutation

Mirati Therapeutics, Inc.0 sites450 target enrollmentStarted: May 10, 2021Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
450
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •Histologically or cytologically confirmed diagnosis of NSCLC with KRAS G12C mutation.
  • •Candidacy to receive treatment with docetaxel.
  • •Crossover Inclusion Criteria
  • •1. Evidence of RECIST 1.1 defined disease progression on docetaxel per
  • •2. ECOG performance status 0 - 2.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 225
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 225

Exclusion Criteria

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

Investigators

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