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

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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

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)

453 participants in 2 patient groups

MRTX849
Experimental group
Treatment:
Drug: MRTX849
Docetaxel
Active Comparator group
Treatment:
Drug: Docetaxel

Trial contacts and locations

228

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Central trial contact

Mirati Therapeutics Study Locator Services

Data sourced from clinicaltrials.gov

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