RecruitingPhase 2NCT05609578
Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation
A Phase 2 Trial of Combination Therapies With Adagrasib in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation
Sponsor
Mirati Therapeutics Inc.
Enrollment
90 participants
Start Date
Nov 22, 2022
Study Type
INTERVENTIONAL
Conditions
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 \<50% and KRAS G12C mutation
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- 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 \<4 cycles of a platinum-based induction, was stopped early due to intolerable toxicity
- Cohort E: Has an untreated and unresectable or metastatic NSCLC with histologically confirmed (non-squamous only) KRASG12C mutation and histologically confirmed PD-L1 TPS \< 50%
- Presence of measurable disease per RECIST v1.1
Exclusion Criteria5
- 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
Interventions
DRUGAdagrasib oral dose of 400 mg twice daily tablets
oral dose of 400 mg twice daily tablets
COMBINATION_PRODUCTPembrolizumab
IV infusion once every 3 weeks
COMBINATION_PRODUCTChemotherapy: Pemetrexed
IV infusion once every 3 weeks
COMBINATION_PRODUCTCisplatin/Carboplatin
IV infusion once every 3 weeks
Locations(166)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05609578
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