Recruiting
Phase 3

RAS(ON) Inhibitor & Pembrolizumab

Sponsor:

Revolution Medicines, Inc.

Code:

NCT07777822

Conditions

NSCLC

Non-small Cell Lung Cancer

Non-Small Cell Lung Cancer NSCLC

Non-Squamous Non Small Cell Lung Cancer

Lung Cancer (NSCLC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

zoldonrasib

Placebo

pembrolizumab

pemetrexed + cisplatin /carboplatin

Study Details

Brief 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)

Study ID

NCT07777822

Start date

Aug 14, 2026

Status verified date

Aug, 2026

Completion date

Feb, 2031

Anticipated

Primary completion date

Oct, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

430 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A: zoldonrasib + pembrolizumab + chemotherapy doublet

study drug in combination with pembrolizumab and platinum-based chemotherapy doublet

placebo comparator: Arm B: placebo + pembrolizumab + chemotherapy doublet

placebo in combination with pembrolizumab and platinum-based chemotherapy doublet

Interventions

zoldonrasib

oral tablets

Placebo

oral tablets

pembrolizumab

IV infusion or Subcutaneous injection

pemetrexed + cisplatin /carboplatin

IV infusion of either pemetrexed + cisplatin or pemetrexed + carboplatin

Primary outcome measure

  • Progression free survival (PFS) [ Time Frame: Up to approximately 5 years ]

Central Contacts and Locations

Central contacts

Revolution Medicines Study Director

1-844-2-REVMEDmedinfo@revmed.com

Locations

Florida Clinical Trials Group, LLC

Recruiting

Plantation, Florida, United States, 33322

Contacts

Sandra Perez

772-297-3057perezs@floridactg.com

More Information

Sponsor

Revolution Medicines, Inc.

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

  • NSCLC
  • Non-Small Cell Lung Cancer
  • Non-Squamous Non Small Cell Lung Cancer
  • Metastatic Non-Squamous Non-Small Cell Lung Cancer
  • RAS
  • KRAS
  • NRAS
  • HRAS
  • RAS Mutation
  • Lung Cancer
  • G12D
  • RAS G12D

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Revolution Medicines, Inc. on 2026-08-20.