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Advanced Non-Small Cell Lung CancerGeneticsCancerDrugPhase 2, Phase 3

What this study is

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 in patients with unresectable, locally advanced or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS >=50% and who are candidates for first line treatment.

What's being tested

  • Adagrasib

    Intervention · DRUG

    Adagrasib 400 mg twice daily (BID) in combination with pembrolizumab (Cohort 1a)

  • Adagrasib

    Intervention · DRUG

    Adagrasib 600 mg BID monotherapy (Cohort 1b)

  • Adagrasib

    Intervention · DRUG

    adagrasib 400 mg BID in combination with pembrolizumab

  • Adagrasib

    Intervention · DRUG

    Adagrasib 400 mg BID + pembrolizumab 200 mg every Q3W

  • Pembrolizumab

    Intervention · DRUG

    Pembrolizumab 200 mg IV Q3W

Study details

Official title
A Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation
Sponsor
Mirati Therapeutics Inc.
Conditions
Advanced Non-Small Cell Lung Cancer · Metastatic Non-Small Cell Lung Cancer
Enrolling
626 people
Starts
2020-12-02
Est. completion
2029-10-31
Design
Open-label, randomized, parallel groups, Phase 2, Phase 3
Record
View on ClinicalTrials.gov ↗