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

Sponsor: Revolution Medicines, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT07777822

This Phase 3, double-blind study assesses zoldonrasib's efficacy with pembrolizumab and platinum chemotherapy in untreated metastatic RAS G12D-mutated NSCLC. Participants, aged 18+, must have ECOG 0-1, confirmed NSCLC, PD-L1, and RAS G12D status, measurable disease, and adequate organ function. Interventions include oral zoldonrasib or placebo, and IV pembrolizumab with pemetrexed and cisplatin/carboplatin.

Patient Parameters

Program Overview

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.

Description

This is a Phase 3, global, randomized, double-blind study designed to evaluate whether treatment with zoldonrasib in combination with pembrolizumab and platinum-based chemotherapy doublet will improve progression-free survival compared to placebo in combination with pembrolizumab and platinum-based chemotherapy doublet when given to patients with previously untreated, 1L metastatic RAS G12D-mutated, non-squamous non-small cell lung cancer (NSCLC).

Patients will be randomized to one of two arms: zoldonrasib + pembrolizumab + platinum-based chemotherapy doublet (Arm A) or placebo + pembrolizumab + platinum-based chemotherapy doublet (Arm B).

Eligibility Criteria

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

Locations

FACILITYZIPCITYSTATE
Florida Clinical Trials Group, LLC33322PlantationFlorida

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