Trials / Active Not Recruiting
Active Not RecruitingNCT05853575
Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21)
A Randomized Study of Two Dosing Regimens of Adagrasib in Patients With Previously Treated Non-Small Cell Lung Cancer With KRAS G12C Mutation
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- Mirati Therapeutics Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
CA239-0012 is a phase 2 study of adagrasib monotherapy in which patients are randomized between two dosing regimens. The study will evaluate the efficacy of two dosing regimens of adagrasib (600 mg BID without regard to food versus 400 mg BID with food) in patients with NSCLC with KRAS G12C mutation and who have received prior treatment with a platinum-based regimen and immune checkpoint inhibitor therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Adagrasib | KRAS G12C inhibitor |
Timeline
- Start date
- 2024-02-16
- Primary completion
- 2026-07-30
- Completion
- 2026-07-30
- First posted
- 2023-05-10
- Last updated
- 2026-03-27
Locations
98 sites across 18 countries: United States, Brazil, Croatia, France, Greece, Israel, Italy, Japan, Mexico, Netherlands, Poland, Romania, Serbia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye)
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05853575. Inclusion in this directory is not an endorsement.