Phase 2 Study of Adagrasib Monotherapy and in Combination With Pembrolizumab and Phase 3 Study of Adagrasib in Combination with Pembrolizumab versus Pembrolizumab in Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation
EU CTIS ID: 2023-508922-83-00
What this study is testing
Phase 2: To evaluate the efficacy of adagrasib monotherapy and in combination with Pembrolizumab administered in the first-line treatment setting to patients having NSCLC with KRAS G12C mutation. Phase 3: To compare the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab alone in first-line NSCLC with KRAS G12C mutation and PD-L1 ≥ 50%.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Phase 2: Histologically confirmed diagnosis of NSCLC (squamous or nonsquamous) with KRAS G12C mutation and known PD-L1 TPS score and presence of measurable disease per RECIST v1.1.
- Phase 3: Histologically or cytologically confirmed diagnosis of unresectable or metastatic NSCLC (squamous or nonsquamous) with KRAS G12C mutation and PD-L1 ≥ 50% confirmed using Sponsor-approved testing (refer to laboratory manual for current list of Sponsor-approved tests).
- Phase 2 and 3: Presence of evaluable or measurable disease per RECIST version 1.1.
- Phase 3: CNS Inclusion–- Based on screening brain imaging, patients must have one of the following: 1. No evidence of brain metastases 2. Untreated asymptomatic brain metastases < 2.0 cm not needing immediate local therapy 3. Previously treated brain metastases not needing immediate local therapy .
- Phase 2 and Phase 3: Not a candidate for definitive therapy (eg, chemoradiation for locally advanced disease).
- Phase 3: A representative tumor specimen (primary or metastatic and newly obtained or archival sample must be available to be submitted to the Sponsor during screening or within 30 days of randomization.
You likely can't join if
- Phase 2 and Phase 3: Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune CIT, or a therapy targeting KRAS G12C mutation (e.g., sotorasib)
- Phase 2 and Phase 3: Radiation to the lung > 30 Gy within 6 months prior to the first dose of study treatment.
- Phase 2: Active brain metastases
- Phase 3: Patients with known central nervous system (CNS) lesions must not have any of the following: 1. Any untreated or symptomatic brain lesions > 2.0 cm in size 2. Any brainstem lesions 3. Ongoing use of systemic corticosteroids for control of symptoms of brain lesions at a total daily dose of > 10 mg of prednisone (or equivalent) prior to randomization. 4. Have poorly controlled (> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain lesions notwithstanding CNS-directed therapy
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- United Kingdom
- Israel
- United States
- Canada
- Taiwan
- Turkey
- Korea, Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; United Kingdom; Israel; United States; Canada; Taiwan and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.