NCT05609578 Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation
| NCT ID | NCT05609578 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Mirati Therapeutics Inc. |
| Condition | Advanced NSCLC |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2022-11-22 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 90 participants in total. It began in 2022-11-22 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 \<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
Contact & Investigator
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
✉ Clinical.Trials@bms.com📞 855-907-3286
Bristol-Myers Squibb
STUDY DIRECTOR
Bristol-Myers Squibb
Frequently Asked Questions
Who can join the NCT05609578 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced NSCLC. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05609578 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05609578 currently recruiting?
Yes, NCT05609578 is actively recruiting participants. Contact the research team at Clinical.Trials@bms.com for enrollment information.
Where is the NCT05609578 trial being conducted?
This trial is being conducted at Anchorage, United States, Glendale, United States, Phoenix, United States, Anaheim, United States and 11 additional locations.
Who is sponsoring the NCT05609578 clinical trial?
NCT05609578 is sponsored by Mirati Therapeutics Inc.. The principal investigator is Bristol-Myers Squibb at Bristol-Myers Squibb. The trial plans to enroll 90 participants.