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Study of Pembrolizumab + Pemetrexed + Platinum Chemotherapy With or Without Zoldonrasib as First Line Treatment in Metastatic Non-squamous RAS G12D-Mutated NSCLC

A Randomized, Double-blind, Phase 3 Study of Pembrolizumab + Pemetrexed + Platinum Chemotherapy With or Without Zoldonrasib (RMC-9805) as First Line Treatment in Patients With Metastatic Non-squamous RAS G12D-Mutated Non-small Cell Lung Cancer (RASolve 308)

Who can join

Ages 18 and older · All sexes

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

About the study

The purpose of this study is to evaluate the efficacy of an investigational RAS(ON) inhibitor administered in combination with pembrolizumab and platinum-based chemotherapy doublet compared to placebo in combination with pembrolizumab and platinum-based chemotherapy doublet.

What is being tested

• zoldonrasib (drug)
• Placebo (drug)
• pembrolizumab (drug)
• pemetrexed + cisplatin /carboplatin (drug)

Sponsor: Revolution Medicines, Inc. · Participants: 430 · Started: Aug 14, 2026

Contact the study team

• Revolution Medicines Study Director · Phone: 1-844-2-REVMED

Official record on ClinicalTrials.gov — NCT07777822

Locations in the U.S.

Conditions

• Non-Small Cell Lung Cancer
• Lung Cancer

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.