Treatment for advanced lung cancer with KRAS G12C mutation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of adagrasib, both as a standalone treatment and in combination with pembrolizumab, for patients with advanced non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation. The study consists of two phases: Phase 2 assesses the treatment in patients with varying PD-L1 TPS scores, while Phase 3 compares the combination therapy against pembrolizumab alone in patients with high PD-L1 expression. The trial aims to determine the effectiveness of these treatments as first-line options for patients with unresectable or metastatic NSCLC.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Phase 2: Histologically confirmed diagnosis of unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS
* Phase 3: Histologically confirmed diagnosis of unresectable or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS\>=50%
* Phase 3: Presence of measurable disease per RECIST1.1
* Phase 3: CNS Inclusion - Based on screening brain imaging, patients must have one of the following:

  1. No evidence of brain metastases
  2. Untreated brain metastases not needing immediate local therapy
  3. Previously treated brain metastases not needing immediate local therapy

Exclusion Criteria:

* Phase 2 and Phase 3: Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation (e.g., AMG 510).
* Phase 2: Active brain metastases
* Phase 3: Patients with known central nervous system (CNS) lesions must not have any of the following:

  1. Any untreated brain lesions \> 2.0 cm in size
  2. Any brainstem lesions
  3. Ongoing use of systemic corticosteroids for control of symptoms of brain lesions at a total daily dose of \> 10 mg of prednisone (or equivalent) prior to randomization.
  4. Have poorly controlled (\> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain lesions notwithstanding CNS-directed therapy
* Phase 3: Radiation to the lung \> 30 Gy within 6 months prior to the first dose of study treatment

Where it's running

• USOR - Arizona Oncology - Prescott Valley
  Prescott Valley, Arizona, United States Recruiting
• Arizona Clinical Research Center
  Tucson, Arizona, United States Recruiting
• Highlands Oncology Group - Springdale
  Springdale, Arkansas, United States Recruiting
• Providence - Saint Joseph Home Health - Anaheim
  Anaheim, California, United States Recruiting
• The Oncology Institute of Hope and Innovation - Corporate Office
  Cerritos, California, United States Recruiting
• MemorialCare - Long Beach Medical Center
  Long Beach, California, United States Recruiting

+720 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.