Phase 3 Study of MRTX849 (Adagrasib) vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-12)

Mirati Therapeutics

Status and phase: Active, not recruiting; Phase 3

Conditions: Advanced Non Small Cell Lung Cancer; Metastatic Non Small Cell Lung Cancer

Treatments: Drug: Docetaxel; Drug: MRTX849

Study type: Interventional

Funder types: Industry

Identifiers

NCT04685135

849-012

CA239-0013

Details and patient eligibility

About

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.

Enrollment: 453 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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453 participants in 2 patient groups

MRTX849

Experimental group

Treatment:

Drug: MRTX849

Docetaxel

Active Comparator group

Treatment:

Drug: Docetaxel