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Trial Summary

The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment.
The Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab plus chemotherapy in patients with unresectable, locally advanced or metastatic nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS <50% and who are candidates for first line treatment.

Acronym:

KRYSTAL -7

ACTRN/NCT /ethics:

NCT04613596

Scientific title:

Phase 2 Trial of MRTX849 Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients KRAS G12C Mutation KRYSTAL-7

Sponsor / Cooperative group:

Mirati Therapeutics Inc.

Trial & Patient Characteristics

Cancer TypeLung
Trial TypeTreatment
PhasePhase II & Phase III
Age Range18 years and older
SexAll
Tumour Stream -
Cancer Stage-
Anticipated Start Date2020-12-02
Anticipated End Date2029-03-31

Participating Hospitals

HospitalFlinders Medical Centre
Clinical Trial CoordinatorAlison Richards
EmailAlison.Richards@sa.gov.au
Phone08 8206 4835
Principal InvestigatorChris Karapetis
Recruitment StatusRecruiting