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Evaluating two dosing regimens of adagrasib for lung cancer with KRAS G12C mutation

A Randomized Study of Two Dosing Regimens of Adagrasib in Patients With Previously Treated Non-Small Cell Lung Cancer With KRAS G12C Mutation

Phase 2 Interventional Mirati Therapeutics Inc. · NCT05853575

This study is testing two different doses of a new lung cancer drug called adagrasib to see which one works better for people with advanced lung cancer that has a specific mutation.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment200 (estimated)
Ages18 Years and up
SexAll
SponsorMirati Therapeutics Inc. Industry-sponsored
Drugs / interventionschemotherapy, prednisone
Locations105 sites (Santa Rosa, California and 104 other locations)
Trial IDNCT05853575 on ClinicalTrials.gov

What this trial studies

This phase 2 study aims to assess the efficacy of two different dosing regimens of adagrasib, a targeted therapy, in patients with advanced non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation. Participants will be randomized to receive either 600 mg of adagrasib twice daily without regard to food or 400 mg twice daily with food. Eligible patients must have previously undergone treatment with a platinum-based chemotherapy and an immune checkpoint inhibitor. The study will monitor treatment outcomes to determine the most effective dosing strategy.

Who should consider this trial

Good fit: Ideal candidates for this study are adults with advanced or metastatic NSCLC who have the KRAS G12C mutation and have previously received specific chemotherapy and immunotherapy.

Not a fit: Patients who have previously been treated with a drug targeting KRAS G12C or those with potentially resectable cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with advanced NSCLC with the KRAS G12C mutation.

How similar studies have performed: Other studies targeting KRAS mutations have shown promising results, indicating potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion 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 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.

Where this trial is running

Santa Rosa, California and 104 other locations

+55 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced CancerMetastatic CancerMalignant Neoplasm of LungKRAS G12CNon-small cell lung cancerMetastatic cancerNSCLC
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.