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Active Not Recruiting
NCT05609578
Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation
Conditions: Advanced NSCLC, Metastatic Lung Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 90
Sponsor: Mirati Therapeutics Inc.
Location: Local Institution - 017-936C Fountain Valley California
Summary
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 \
Eligibility Criteria
Cohort A\* (closed): Has an untreated and unresectable or metastatic NSCLC with histologically confirmed (squamous or nonsquamous) KRASG12C mutation and histologically confirmed PD-L1 TPS ≥1%.
* Cohort C: Has an untreated and unresectable or metastatic NSCLC with histologically confirmed (non-squamous only) KRASG12C mutation and histologically confirmed PD-L1 TPS \< 50% AND previously completed 4 cycles of standard-of-care platinum based induction chemotherapy with pembrolizumab AND experienced stable disease, partial response, or complete response per investigator's assessment after 4 cycles OR if patients received \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
Source: ClinicalTrials.gov (NCT05609578). StuddyBuddy aggregates publicly available trial information.