Revolution Medicines Begins Treating Patients in Phase 3 RASolve 308 Trial Evaluating Zoldonrasib in Combination with Pembrolizumab and Chemotherapy as First-Line Treatment for Patients with Metastatic RAS G12D Non-Squamous Non-Small Cell Lung Cancer

The study tests whether adding zoldonrasib to pembrolizumab and chemotherapy improves progression-free survival versus the placebo combination.

Rhea-AI Summary

Revolution Medicines (RVMD) has begun treating patients in a Phase 3 trial testing zoldonrasib with pembrolizumab and chemotherapy for metastatic lung cancer. The global RASolve 308 trial enrolls adults with previously untreated metastatic RAS G12D non-squamous non-small cell lung cancer. Zoldonrasib is an investigational drug designed to inhibit the active form of RAS G12D.

The randomized, double-blind study compares zoldonrasib plus pembrolizumab and a platinum-based chemotherapy doublet against placebo plus the same standard treatments. Its primary endpoint is progression-free survival, measuring time without cancer worsening or death. Revolution Medicines described earlier combination data in this patient population as showing encouraging preliminary antitumor activity and a favorable safety profile.

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• Moderate pointPhase 3 RASolve 308 has begun treating patients with previously untreated metastatic RAS G12D non-squamous lung cancer.
• Minor pointEarlier combination data showed encouraging preliminary antitumor activity and a favorable safety profile, the company said.

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Key Figures

Trial phase: Phase 3 Patient population frequency: Approximately 4% of cases

Trial phase

Phase 3

RASolve 308 evaluates zoldonrasib with pembrolizumab and chemotherapy

Patient population frequency

Approximately 4% of cases

Metastatic RAS G12D non-squamous NSCLC

Previous Clinical trial Reports

1 past event · Latest: Oct 05

Same Type 1 event

1. Oct 05

   Phase 3 trial start

   24h Move

   +0.5%

   Began treating patients in a Phase 3 zoldonrasib combination trial for pancreatic cancer.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

progression-free survival, overall survival, objective response rate, double-blind, +1 more

5 terms

progression-free survival medical

"The primary endpoint is progression-free survival."

Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.

overall survival medical

"Key secondary endpoints include overall survival, objective response rate"

Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.

objective response rate medical

"Key secondary endpoints include overall survival, objective response rate"

The objective response rate (ORR) is the percentage of patients in a clinical trial whose tumors measurably shrink or disappear according to preset rules. Investors use it as a quick, objective signal of a drug’s ability to produce a clear treatment effect—like counting how many plants visibly respond after applying a new fertilizer—and higher ORR can improve odds of regulatory approval, commercial success, and company valuation.

double-blind technical

"a global, randomized, double-blind Phase 3 trial"

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

primary endpoint medical

"The primary endpoint is progression-free survival."

The primary endpoint is the single main result a clinical study is designed to measure to decide if a treatment works, like the finish line in a race that tells you who won. Investors care because meeting or missing this goal drives regulatory decisions, future sales expectations and stock value — it turns trial data into a clear yes-or-no signal about a drug’s commercial prospects.

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REDWOOD CITY, Calif., Oct. 20, 2026 (GLOBE NEWSWIRE) -- 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, today announced 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).

“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 RASONQUE^TM (daraxonrasib), as well as standard of care regimens in lung and gastrointestinal cancers.

About Revolution Medicines, Inc.
Revolution Medicines is a global, commercial-stage oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide. For more information, visit www.revmed.com and follow Revolution Medicines on LinkedIn, X (Twitter) and Instagram.

Forward-Looking Statements 
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered "forward-looking statements," including without limitation statements regarding the broad potential of RAS(ON) inhibition, including in lung and gastrointestinal cancers; treatment practices for lung cancer; the company’s development strategy; and progression of clinical studies and findings from these studies, including the tolerability, safety, and potential efficacy of the company's candidates being studied.

Forward-looking statements are typically, but not always, identified by the use of words such as "aims," "anticipate," "believe," "estimate," "expect," "plan," "potential," "project," "up to," "will" and other similar terminology indicating future results. Such forward-looking statements are subject to substantial risks and uncertainties that could cause the company's development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include without limitation risks and uncertainties inherent in the drug development process, including the company's programs' development stages, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, the company's ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of the company's capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape, and the effects on the company's business of global events, such as international conflicts or global pandemics. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Revolution Medicines in general, see Revolution Medicines' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the "SEC") on August 5, 2026, and its future periodic reports to be filed with the SEC. Except as required by law, Revolution Medicines undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances, or to reflect the occurrence of unanticipated events.

Revolution Medicines Media & Investor Contacts 

Media
media@revmed.com  

Investors
investors@revmed.com 

References

¹ American Cancer Society. What Is Lung Cancer? Available at: https://www.cancer.org/cancer/types/lung-cancer/about/what-is.html. Accessed August 2026.
² American Cancer Society. Key Statistics for Lung Cancer. Available at: https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html. Accessed August 2026.
³ Reita D, Pabst L, Pencreach E, et al. Direct targeting KRAS mutation in non-small cell lung cancer: Focus on resistance. Cancers (Basel). 2022;14(15):1321. doi:10.3390/cancers14051321
⁴ Estimated using tumor mutation frequencies from Foundation Medicine Insights March 2022 and scaled to estimated patient numbers using cancer incidence from ACS Cancer Facts and Figures 2023.

FAQ

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What is Revolution Medicines testing in the Phase 3 RASolve 308 trial?

RASolve 308 tests zoldonrasib with pembrolizumab and platinum-based chemotherapy in adults with previously untreated metastatic RAS G12D non-squamous non-small cell lung cancer. The randomized, double-blind trial compares that combination with placebo plus pembrolizumab and the same chemotherapy.

What outcomes will Revolution Medicines measure in RASolve 308?

The primary endpoint is progression-free survival, measuring time without cancer worsening or death. Secondary endpoints include overall survival, objective response rate, duration of response, safety and tolerability, and patient-reported outcomes.