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

Part of paid clinical trials in Plantation, Florida.

Sponsor
Revolution Medicines, Inc.
Study ID
NCT07777822
Phase
PHASE3
Status
Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • zoldonrasib — DRUG
    oral tablets
  • Placebo — DRUG
    oral tablets
  • pembrolizumab — DRUG
    IV infusion or Subcutaneous injection
  • pemetrexed + cisplatin /carboplatin — DRUG
    IV infusion of either pemetrexed + cisplatin or pemetrexed + carboplatin

Study Details

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.

Key Dates

First listed
Aug 20, 2026
Start date
Aug 14, 2026
Status verified
Aug 2026
Primary completion
Oct 31, 2029
Completion
Feb 28, 2031

Study Design

Enrollment
430 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Florida Clinical Trials Group, LLCPlantationFlorida33322
Sandra Perez
772-297-3057

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