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

Trial summary:

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.

Receptor status / problem studied:

KRAS G12C Mutation

Inclusion criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of NSCLC with KRAS G12C mutation.
  • Candidacy to receive treatment with docetaxel.

Crossover Inclusion Criteria:

  • Evidence of RECIST 1.1 defined disease progression on docetaxel per BICR
  • ECOG performance status 0-2

Exclusion criteria

Exclusion Criteria:

  • Prior treatment with an agent targeting KRAS G12C (e.g., AMG 510, Sotorasib).
  • Active brain metastases.

Crossover Exclusion Criteria:

  • Receipt of any other systemic anti-cancer therapy after last administration of docetaxel on the study.

View more trial information

Open for recruitment

Trial Title

KRYSTAL-12

Diagnosis

Lung cancer

Type of trial

Pharmaceutical

Type of treatement

Medical Oncology

Phase

III

Locations

Investigators

Principal Investigator
Lihat semua clinical trials

Cari