NCT07777822RecruitingPhase 3
Study of Pembrolizumab + Pemetrexed + Platinum Chemotherapy With or Without Zoldonrasib as First Line Treatment in Metastatic Non-squamous RAS G12D-Mutated NSCLC
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)
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 430 (estimated)
- First submitted
- 17 Aug 2026
- Start date
- 14 Aug 2026
- Primary completion date
- Oct 2029
- Lead sponsor
- Revolution Medicines, Inc.
- Diseases
- Lung cancer
- NCT number
- NCT07777822
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 430
- From 14 Aug 2026 to the primary completion date, Oct 2029
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with systemic anticancer therapy in metastatic setting for NSCLC.
- Prior systemic therapy with any RAS-directed therapy.
- Major surgery on or within 28 days prior to randomization.
Other illness
- Untreated (symptomatic or asymptomatic) central nervous system metastatic disease.
- Any conditions that may affect the ability to take or absorb study drug.
Other
- Patient is unable or unwilling to comply with protocol-required study visits or procedures.
- Additional inclusion and exclusion criteria may apply
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Alaska Oncology and Hematology Coordinator of this site? Confirm its status | Anchorage | United States | Recruiting |
| Helios CR, Inc. - The Oncology Institute of Hope and Innovation - Fort Lauderdale Coordinator of this site? Confirm its status | Fort Lauderdale | United States | Recruiting |
| Florida Clinical Trials Group, LLC Coordinator of this site? Confirm its status | Plantation | United States | Recruiting |
| Florida Clinical Trials Group. Coordinator of this site? Confirm its status | Plantation | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.