On October 20, 2026 Revolution Medicines, Inc. (Nasdaq: RVMD), a global, commercial-stage oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers, reported that it has begun treating patients in RASolve 308, a global Phase 3 clinical trial evaluating zoldonrasib, an investigational, RAS(ON) G12D-selective inhibitor, in combination with standard of care pembrolizumab plus chemotherapy as a first-line treatment in adult patients with metastatic RAS G12D non-squamous non-small cell lung cancer (NSCLC).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"Patients with metastatic RAS G12D non-squamous NSCLC, occurring in approximately 4% of cases, represent an underserved population, with no approved targeted treatment options. Initial clinical data evaluating zoldonrasib in combination with standard of care pembrolizumab and platinum doublet chemotherapy in patients with previously untreated metastatic RAS G12D non-squamous NSCLC showed encouraging preliminary antitumor activity and a favorable safety profile, providing strong clinical rationale for the Phase 3 RASolve 308 trial. This study, along with additional registrational trials underway in multiple tumor types across our pipeline of differentiated RAS(ON) inhibitors, underscores our commitment to establishing RAS(ON) inhibition as a new standard of care and backbone for treating patients with RAS-addicted cancers," said Alan Sandler, M.D., chief development officer of Revolution Medicines.
RASolve 308 (NCT07777822) is a global, randomized, double-blind Phase 3 trial evaluating zoldonrasib in combination with pembrolizumab and platinum-based chemotherapy doublet compared with placebo in combination with pembrolizumab and platinum-based chemotherapy doublet in the treatment of adult patients with previously untreated metastatic RAS G12D non-squamous NSCLC. The primary endpoint is progression-free survival. Key secondary endpoints include overall survival, objective response rate, duration of response, safety and tolerability, and patient-reported outcomes.
About Non-Small Cell Lung Cancer
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for 80%–85% of all lung cancers, with more than 229,000 people diagnosed in the U.S. each year.1,2 Despite treatment advancements, NSCLC remains a leading cause of cancer-related mortality worldwide, primarily due to its late-stage diagnosis and limited response to conventional therapies. RAS mutations are among the most common oncogenic drivers in NSCLC, occurring in approximately 30% of cases. Of those, RAS G12D mutations occur in about 4% of NSCLC cases.³
About Zoldonrasib
Zoldonrasib is an investigational, oral, RAS(ON) G12D-selective covalent, tri-complex inhibitor that binds to cyclophilin A, creating a binary complex that binds to and inhibits the active, oncogenic RAS(ON) G12D mutation. RAS G12D is the most prevalent RAS mutation, accounting for approximately 29% of all RAS-driven cancers.4 Across tumor types, approximately 61,000 new patients with RAS G12D cancers are estimated annually in the U.S., with no targeted therapy currently approved for these patients.4 Zoldonrasib is currently being investigated as a monotherapy and in combination with other therapies, including with Revolution Medicines’ RAS(ON) multi-selective inhibitor RASONQUETM (daraxonrasib), as well as standard of care regimens in lung and gastrointestinal cancers.
(Press release, Revolution Medicines, OCT 20, 2026, View Source [SID1234673611])