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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

NCT07777822 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 430

Last updated 2026-08-20

No results posted yet for this 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.

Conditions

  • NSCLC
  • Non-small Cell Lung Cancer
  • Non-Small Cell Lung Cancer NSCLC
  • Non-Squamous Non Small Cell Lung Cancer
  • Lung Cancer (NSCLC)
  • Metastatic NSCLC - Non-Small Cell Lung Cancer
  • Metastatic Non-Squamous Non-Small Cell Lung Cancer

Interventions

DRUG

zoldonrasib

oral tablets

DRUG

Placebo

oral tablets

DRUG

pembrolizumab

IV infusion or Subcutaneous injection

DRUG

pemetrexed + cisplatin /carboplatin

IV infusion of either pemetrexed + cisplatin or pemetrexed + carboplatin

Sponsors & Collaborators

  • Revolution Medicines, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-14
Primary Completion
2029-10-31
Completion
2031-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07777822 on ClinicalTrials.gov