USClinicalTrials.govClinical trialPhase 2Active, not recruiting
Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21)
Official record
- Identifier
NCT05853575- Recruiting locations
countries
United StatesBrazilCroatiaFranceGreeceIsraelItalyJapanMexicoNetherlandsPolandRomaniaSerbiaSouth KoreaSpainTaiwanThailandTurkey (Türkiye)- Interventions studied
- Adagrasib
- Lead sponsor
- Mirati Therapeutics Inc.
- Target enrolment
- 200 participants
- Study type
- INTERVENTIONAL
- Phase
- Phase 2
- Status
- Active, not recruiting
- First posted
- May 10, 2023
- Last updated on the registry
- Aug 14, 2026
- Age
- 18 Years
- Sex
- ALL
- Study contact
- No public contact is listed on the official record.
- Eligibility criteria
Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.
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 brain lesions are not eligible if 1) any untreated brain lesions are \> 2.0 cm in size 2) any brainstem lesions are present 3) ongoing steroid dosing \>10 mg daily prednisone (or equivalent) and 4) poorly controlled (\> 1/week) generalized or complex partial seizures or neurologic progression/instability due to brain lesions. * 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.
- Indexed under
- Lung Cancer