CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 90 target
Drug / intervention
Adagrasib oral dose of 400 mg twice daily tablets +3 moredrug
Likely dose
Adagrasib oral dose of 400 mg twice daily tabletsfrom record
Key inclusion· 6
  • ✓Untreated and unresectable or metastatic NSCLC
  • ✓Histologically confirmed KRASG12C mutation (squamous or nonsquamous in Cohort A; non-squamous only in Cohorts C & E)
  • ✓Histologically confirmed PD-L1 TPS ≥1% (Cohort A)
  • ✓Histologically confirmed PD-L1 TPS < 50% (Cohorts C & E)
Key exclusion· 5
  • ✕Any prior therapy targeting KRASG12C mutation in any setting
  • ✕Cohorts A & E: Prior systemic therapy for locally advanced or metastatic NSCLC (chemotherapy, immune checkpoint inhibitor therapy, or chemoimmunotherapy); adjuvant/neoadjuvant allowed if >1 year prior
  • ✕Cohort C: No prior maintenance therapy (pembrolizumab and/or pemetrexed) after platinum-based regimen
  • ✕Radiation to the lung > 30 Gy within 6 months prior to first dose of study treatment

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT05609578Phase 2ActiveOn Track
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A Phase 2 Trial of Combination Therapies With Adagrasib in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation

Mirati Therapeutics Inc.·interventional·Posted Nov 8, 2022·Updated Jun 23, 2026

In Brief

A Phase 2 clinical trial evaluating Adagrasib oral dose of 400 mg twice daily tablets, Pembrolizumab, and 2 other interventions for Advanced NSCLC and Metastatic Lung Cancer. Active but no longer recruiting, targeting 90 participants across 94 sites in 7 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced NSCLC, Metastatic Lung Cancer
CountriesFrance, Greece, Hungary, Italy, Poland, Spain, United States
Collaborators--

Timeline

Phase 2Active
20232024202520262027
First PostedNov 8, 2022
Enrollment StartNov 22, 2022
Primary CompletionSep 30, 2026
Study CompletionDec 1, 2026
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 3.6 years agoPrimary completion in 3 months

Arms & Interventions

Cohort A: PD-L1 TPS≥ 1% (Closed)experimental

Adagrasib 400 mg BID for 2 cycles followed by adagrasib 400 mg BID + pembrolizumab 200 mg every 3 weeks (Q3W) up to 35 cycles

Drug: Adagrasib oral dose of 400 mg twice daily tablets
Cohort Cexperimental

Adagrasib 400 mg BID + pemetrexed 500 mg/m2 Q3W + pembrolizumab 200 mg Q3W up to 31 cycles

Drug: Adagrasib oral dose of 400 mg twice daily tabletsCombination Product: PembrolizumabCombination Product: Chemotherapy: PemetrexedCombination Product: Cisplatin/Carboplatin
Cohort Eexperimental

Adagrasib 400 mg BID + pembrolizumab 200 mg Q3W + pemetrexed 500 mg/m2 + cisplatin 75 mg/m2 Q3W OR carboplatin AUC 5 Q3W for 4 cycles, followed by adagrasib 400 mg BID + pemetrexed 500 mg/m2 Q3W + pembrolizumab 200 mg Q3W (up to 31 cycles)

Drug: Adagrasib oral dose of 400 mg twice daily tabletsCombination Product: PembrolizumabCombination Product: Chemotherapy: PemetrexedCombination Product: Cisplatin/Carboplatin

Interventions

Adagrasib oral dose of 400 mg twice daily tabletsdrug

oral dose of 400 mg twice daily tablets

Pembrolizumabcombination

IV infusion once every 3 weeks

Chemotherapy: Pemetrexedcombination

IV infusion once every 3 weeks

Cisplatin/Carboplatincombination

IV infusion once every 3 weeks