Last updated 36 hours ago
Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21)
200 patients around the world
Available in Spain, Brazil, United States, Mexico
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.
Mirati Therapeutics Inc.
200Patients around the world
This study is for people with
Lung cancer
Non-small cell lung carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
SponsorMirati Therapeutics Inc.
Conditions
Non-small cell lung carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05853575
