Active — Not RecruitingPhase 3

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

United States345 participantsStarted 2020-06-04

Plain-language summary

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

Who can participate

Age range18 Years – 100 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Progression-free Survival (PFS)

Timeframe: Baseline up to primary analysis data cut-off date (02 August 2022); max time on study as of primary analysis data cut off was 24.3 months

Trial details

NCT IDNCT04303780

SponsorAmgen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-08-02

Results submitted2023-04-17

View on ClinicalTrials.gov More KRAS p, G12c Mutated /Advanced Metastatic NSCLC trials