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
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 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