Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21)

• Status: Recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy of two dosing regimens of adagrasib (600 mg BID versus 400 mg BID) in patients with NSCLC with KRAS G12C mutation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mirati Therapeutics Inc.
• Treatments: Adagrasib

Criteria

Key Inclusion Criteria:

• Are at least 18 years old (or old enough to legally make their own treatment decisions, according to local laws).

• Have advanced NSCLC or metastatic NSCLC (NSCLC that started in the lungs and then spread to other parts of the body) with the KRAS G12C mutation.

• Have had previous treatment with 1) chemotherapy that included a drug called cisplatin or a drug called carboplatin and 2) a type of drug called an immune checkpoint inhibitor.

• Have recovered from their prior treatment and blood tests are within a safe range.

Key Exclusion Criteria:

• Have had previous treatment with a drug that targets KRAS G12C.

• Have cancer that can potentially be removed with surgery.

• Patients with active brain metastases are eligible if 1) brain metastases are adequately treated and 2) are neurologically stable for at least 2 weeks prior to randomization.

• Steroid dosing > 10 mg daily prednisone (or equivalent).

• Have certain medical conditions or need to take certain medications that, in the opinion of a trial doctor, could make it unsafe for them to participate or difficult to complete the trial assessments, or are pregnant.