Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).

Sponsor: Amgen

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04303780

Patient View

This Phase 3 trial evaluates AMG 510 versus Docetaxel in NSCLC patients with KRAS p.G12C mutation. Eligible participants are adults (≥18 years) with ECOG ≤ 1, having previously treated, locally-advanced, unresectable, or metastatic NSCLC. Both interventions are administered in 21-day cycles. Participants must have confirmed KRAS p.G12C mutation through central testing or prior Amgen study.

Patient Parameters

Program Overview

A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation

Eligibility Criteria

Inclusion Criteria

  • Men or women greater than or equal to 18 years old.
  • ECOG ≤ 1
  • Pathologically documented, previously treated, locally-advanced and unresectable or metastatic NSCLC with KRAS p.G12C mutation confirmed through central testing or have documentation of KRAS p.G12C mutation through Amgen Study 20190294 prior to enrollment

Exclusion Criteria

  • Active brain metastases
  • Myocardial infarction within 6 months of study day 1
  • Gastrointestinal (GI) tract disease causing the inability to take oral medication

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