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Clinical Trials in Spain / NCT05609578
Active, not recruiting Phase 2

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

NCT05609578 · tracked via the Priya Life Science Spain tracker
Phase
Phase 2
Started
2022-11-22
Last updated
2026-06-23

Condition(s) studied

Advanced NSCLCMetastatic Lung Cancer

Investigational drug(s) / intervention(s)

Adagrasib oral dose of 400 mg twice daily tablets →PembrolizumabChemotherapy: PemetrexedCisplatin/Carboplatin

Adagrasib oral dose of 400 mg twice daily tablets: oral dose of 400 mg twice daily tablets

Pembrolizumab: IV infusion once every 3 weeks

Chemotherapy: Pemetrexed: IV infusion once every 3 weeks

Cisplatin/Carboplatin: IV infusion once every 3 weeks

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (94)

FacilityCityRegionStatus
Local Institution - 017-936C Fountain Valley California
Local Institution - 017-936 Fountain Valley California
Local Institution - 017-851 Fullerton California
Local Institution - 017-540 San Francisco California
Local Institution - 017-872-I Aurora Colorado
Local Institution - 017-872-G Boulder Colorado
Local Institution - 017-872-D Colorado Springs Colorado
Local Institution - 017-872-J Colorado Springs Colorado
Local Institution - 017-872-B Denver Colorado
Local Institution - 017-872-F Denver Colorado
Local Institution - 017-872-A Lakewood Colorado
Local Institution - 017-872-C Littleton Colorado
Local Institution - 017-872 Lone Tree Colorado
Local Institution - 017-872-E Pueblo Colorado
Local Institution - 017-872-H Thornton Colorado
Local Institution - 017-829 Jacksonville Florida
Local Institution - 017-898 Lakeland Florida
Local Institution - 017-972 Chicago Illinois
Local Institution - 017-820J Fairway Kansas
Local Institution - 017-820A Kansas City Kansas
Local Institution - 017-820B Kansas City Kansas
Local Institution - 017-820C Kansas City Kansas
Local Institution - 017-820H Kansas City Kansas
Local Institution - 017-820I Overland Park Kansas
Local Institution - 017-820 Westwood Kansas
Local Institution - 017-388 Boston Massachusetts
Local Institution - 017-808 Boston Massachusetts
Local Institution - 017-811 Novi Michigan
Local Institution - 017-838B Minneapolis Minnesota
Local Institution - 017-838C Minneapolis Minnesota
Local Institution - 017-830 Rochester Minnesota
Local Institution - 017-838 Saint Louis Park Minnesota
Local Institution - 017-838A Saint Louis Park Minnesota
Local Institution - 017-820F Kansas City Missouri
Local Institution - 017-820E Kansas City Missouri
Local Institution - 017-820D Lee's Summit Missouri
Local Institution - 017-820G North Kansas City Missouri
Local Institution - 017-080 Babylon New York
Local Institution - 017-088 Brooklyn New York
Local Institution - 017-587 East Syracuse New York

+ 54 more sites — see the full list on the official registry below.

On this site

📄 Keytruda (pembrolizumab) drug profile →

More Mirati Therapeutics Inc. trials in Spain

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05609578 on ClinicalTrials.gov ↗ ← All trials in Spain