Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation

Sponsor: Mirati Therapeutics Inc.

Sponsor score: 40

ClinicalTrials ID:NCT05609578

Study CA239-0010 is a Phase 2 trial assessing adagrasib with pembrolizumab and chemotherapy in advanced NSCLC patients with KRAS G12C mutation. Eligible participants have TPS ≥ 1% and TPS < 50%. Interventions include oral adagrasib (400 mg twice daily) and IV infusions of pembrolizumab, pemetrexed, and cisplatin/carboplatin every three weeks.

Patient Parameters

Program Overview

Study CA239-0010 is an open-label, Phase 2 clinical trial evaluating the clinical efficacy of adagrasib in combination with pembrolizumab and chemotherapy in the first-line setting for patients with advanced NSCLC with TPS ≥ 1%, TPS <50% and KRAS G12C mutation

Eligibility Criteria

Exclusion Criteria

  • All Cohorts: Any prior therapy targeting KRASG12C mutation in any setting
  • Cohorts A & E: Prior systemic therapy for locally advanced or metastatic NSCLC, including chemotherapy, immune checkpoint inhibitor therapy or chemoimmunotherapy (note: prior systemic therapy or chemoradiation given in the adjuvant or neoadjuvant setting are allowed if last dose of prior systemic treatment was >1 year prior to first dose of study treatment)
  • Cohort C: received maintenance therapy (e.g, pembrolizumab and/or pemetrexed following completion of 4-6 cycles of a platinum-based regimen administered in the first-line setting
  • Radiation to the lung > 30 Gy within 6 months prior to first dose of study treatment
  • Active brain metastases

Locations

FACILITYZIPCITYSTATE
Local Institution - Unk02599508AnchorageAlaska
Local Institution - 017-59185304GlendaleArizona
Local Institution - 017-82185004PhoenixArizona
Local Institution - Unk04792805AnaheimCalifornia
Local Institution - 017-936C92708Fountain ValleyCalifornia
MemorialCare - Orange Coast Medical Center92708Fountain ValleyCalifornia
Providence Medical Foundation - Virginia K. Crosson Cancer Center - Fullerton92835FullertonCalifornia
Local Institution - Unk00492354Loma LindaCalifornia
Local Institution - 017-96190095Los AngelesCalifornia
UCSF Helen Diller Family Comprehensive Cancer Center94158San FranciscoCalifornia

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