Actively Recruiting
A Randomized, Double-Blind Phase 3 Trial of Adagrasib Plus Pembrolizumab Plus Chemotherapy versus Placebo Plus Pembrolizumab Plus Chemotherapy in Participants with Previously Untreated Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer with KRAS G12C Mutation
Led by Mirati Therapeutics Inc. · Updated on 2026-06-02
630
Participants Needed
353
Research Sites
138 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of adagrasib, pembrolizumab, and platinum-doublet chemotherapy compared to placebo plus pembrolizumab and platinum-doublet chemotherapy in adults with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC that has a KRAS G12C mutation. This Phase 3 randomized, double-blind trial aims to assess the efficacy, safety, and tolerability of these treatments in this specific patient population. Participants will receive either adagrasib with pembrolizumab and chemotherapy drugs carboplatin or cisplatin plus pemetrexed, or a placebo combined with pembrolizumab and the same chemotherapy drugs. Dosing schedules are specified but not detailed here, and treatment is given according to the studys protocol. The trial includes a placebo comparator group and uses quadruple masking to maintain blinding. Throughout the study, participants will be monitored for progression-free survival and overall survival for up to seven years. Assessments include imaging scans to measure tumor response, quality of life questionnaires, and monitoring for adverse events related to treatment. Safety evaluations continue for up to 90 days after the last dose. The study duration varies, with extensive follow-up to track treatment outcomes and side effects.
CONDITIONS
Brief Title
A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed diagnosis of non-squamous NSCLC with KRAS G12C mutation via tumor sample or circulating tumor DNA
- Locally advanced or metastatic disease
- Measurable disease with at least one lesion by CT or MRI per RECIST v1.1
- No prior systemic anti-cancer therapy for advanced or metastatic disease
- Not a candidate for definitive therapy such as chemoradiation or complete surgical resection
- Brain metastases allowed if asymptomatic, untreated, and 2 mm or smaller
- Any PD-L1 expression level (0 to 100%) as determined by specified assays
You will not qualify if you...
- Active autoimmune or inflammatory disease needing systemic treatment within the past 2 years
- Uncontrolled or significant cardiovascular conditions within 6 months prior to enrollment
- Inadequate bone marrow or liver function, or ECG abnormalities
- Ongoing treatment with medications causing prolonged QTc interval that cannot be changed before study start
- Prior treatment targeting KRAS G12C mutation such as sotorasib or adagrasib
- Severe acute or chronic medical or psychiatric conditions or lab abnormalities increasing risk with study participation
- Other protocol-defined exclusion criteria
Research Team
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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
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First line of the email MUST contain NCT # and Site #.
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