Combining adagrasib, pembrolizumab, and chemotherapy for lung cancer with a specific 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 trial evaluates the effectiveness and safety of a combination treatment involving adagrasib, pembrolizumab, and chemotherapy in patients with previously untreated non-squamous non-small cell lung cancer (NSCLC) that has a KRAS G12C mutation. Participants will receive either the combination therapy or a placebo alongside pembrolizumab and chemotherapy. The study aims to determine if this new treatment approach can improve outcomes for patients with this specific type of lung cancer. The trial is designed for those with locally advanced or metastatic disease who have not received prior systemic therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of non-squamous NSCLC with evidence of KRAS G12C mutation via tumor sample and/or circulating tumor deoxyribonucleic acid (ctDNA).
* Locally advanced or metastatic disease.
* Measurable disease via computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria of at least 1 lesion.
* No prior systemic anti-cancer therapy given for advanced or metastatic disease.
* Not a candidate for definitive therapy (eg, chemoradiation or complete surgical resection).
* Participants with brain metastases are eligible for enrollment, including those with untreated brain metastases. Brain metastases must be asymptomatic and not in need of immediate local therapy. Any untreated brain metastases must be ≤ 20 mm in diameter.
* Any PD-L1 expression (0 to 100%) as determined by VENTANA PD-L1 (SP263) assay, Agilent PD-L1 IHC 22C3 pharmDx, or Agilent PD-L1 IHC 28-8 pharmDx.

Exclusion Criteria:

* Participants with an active autoimmune or inflammatory disease requiring systemic treatment within 2 years.
* Uncontrolled or significant cardiovascular conditions within 6 months prior to enrollment that are ongoing or with risk of recurrence.
* Inadequate bone marrow or liver function or electrocardiogram (ECG) abnormalities.
* Ongoing treatment with concomitant medication known to cause prolonged QTc interval and that cannot be switched to alternative treatment prior to study entry.
* Treatment targeting KRAS G12C mutation (eg, sotorasib, adagrasib) in any setting.
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Highlands Oncology Group - Springdale
  Springdale, Arkansas, United States Recruiting
• Providence Medical Foundation
  Fullerton, California, United States Recruiting
• Helios Clinical Research
  Long Beach, California, United States Recruiting
• National Jewish Health Medical Center
  Denver, Colorado, United States Recruiting
• Medical Oncology Hematology Consultants, PA
  Newark, Delaware, United States Recruiting

+267 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.