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

NCT07777822 · tracked via the Priya Life Science USA tracker

Sponsor

Revolution Medicines, Inc.

Phase

Phase 3

Started

2026-08-14

Last updated

2026-08-20

Condition(s) studied

NSCLCNon-small Cell Lung CancerNon-Small Cell Lung Cancer NSCLCNon-Squamous Non Small Cell Lung CancerLung Cancer (NSCLC)Metastatic NSCLC - Non-Small Cell Lung CancerMetastatic Non-Squamous Non-Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

zoldonrasibPlacebopembrolizumabpemetrexed + cisplatin /carboplatin

zoldonrasib: oral tablets

Placebo: oral tablets

pembrolizumab: IV infusion or Subcutaneous injection

pemetrexed + cisplatin /carboplatin: IV infusion of either pemetrexed + cisplatin or pemetrexed + carboplatin

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Progression free survival (PFS) — Up to approximately 5 years
PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is assessed per response evaluation criteria in solid tumors (RECIST) v1.1 by blinded independent central review (BICR).

Trial sites (1)

Facility	City	Region	Status
Florida Clinical Trials Group, LLC	Plantation	Florida	Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07777822 on ClinicalTrials.gov ↗ ← All trials in the USA