First-line treatment with pembrolizumab, pemetrexed, and platinum with or without zoldonrasib for metastatic non-squamous NSCLC

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 is a global, phase 3, randomized, double-blind study comparing zoldonrasib plus pembrolizumab and a platinum doublet to placebo plus pembrolizumab and a platinum doublet in previously untreated metastatic non-squamous NSCLC with a confirmed RAS G12D mutation. Participants are assigned to Arm A (zoldonrasib) or Arm B (placebo), in addition to standard pembrolizumab and platinum-based chemotherapy. The primary objective is to determine if progression-free survival is improved with the zoldonrasib-containing regimen. Key eligibility includes adults with good performance status, confirmed disease, measurable disease, and documented RAS G12D mutation; prior systemic therapy for metastatic NSCLC is excluded. Exclusion criteria cover untreated CNS metastases and conditions affecting study drug absorption or compliance.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* At least 18 years old and has provided informed consent.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Histologically or cytologically confirmed, previously untreated metastatic non-squamous NSCLC.
* Known PD-L1 status
* Documented RAS G12D mutation status.
* Measurable disease per RECIST v1.1.
* Adequate organ function (bone marrow, liver, kidney, coagulation, thyroid).
* Able to take oral medications.

Exclusion Criteria:

* Prior treatment with systemic anticancer therapy in metastatic setting for NSCLC.
* Prior systemic therapy with any RAS-directed therapy.
* Untreated (symptomatic or asymptomatic) central nervous system metastatic disease.
* Any conditions that may affect the ability to take or absorb study drug.
* Major surgery on or within 28 days prior to randomization.
* Patient is unable or unwilling to comply with protocol-required study visits or procedures.
* Additional inclusion and exclusion criteria may apply

Where it's running

• Alaska Oncology and Hematology
  Anchorage, Alaska, United States Recruiting
• Helios CR, Inc. - The Oncology Institute of Hope and Innovation - Fort Lauderdale
  Fort Lauderdale, Florida, United States Recruiting
• Florida Clinical Trials Group, LLC
  Plantation, Florida, United States Recruiting
• Florida Clinical Trials Group
  Plantation, Florida, United States Recruiting

Study contacts

• Study coordinator: Revolution Medicines Study Director
• Email: medinfo@revmed.com
• Phone: 1-844-2-REVMED

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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.