A Randomized, Double-blind, Phase 3 Study of Pembrolizumab + Pemetrexed + Platinum Chemotherapy With or Without Zoldonrasib (RMC-9805) as First Line Treatment in Patients With Metastatic Non-squamous RAS G12D-Mutated Non-small Cell Lung Cancer (RASolve 308)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Florida
Florida Clinical Trials Group, LLC
RECRUITING
Plantation
Contact Information
Primary
Revolution Medicines Study Director
medinfo@revmed.com
1-844-2-REVMED
Time Frame
Start Date: 2026-08-14
Estimated Completion Date: 2031-02
Participants
Target number of participants: 430
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Revolution Medicines, Inc.