Study of Pembrolizumab + Pemetrexed + Platinum Chemotherapy With or Without Zoldonrasib as First Line Treatment in Metastatic Non-squamous RAS G12D-Mutated NSCLC
Recruiting · NCT07777822 · Interventional (participants receive a specific treatment) · Lead sponsor: Revolution Medicines, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- Prior treatment with systemic anticancer therapy in metastatic setting for NSCLC.
- Prior systemic therapy with any RAS-directed therapy.
- Untreated (symptomatic or asymptomatic) central nervous system metastatic disease.
- Any conditions that may affect the ability to take or absorb study drug.
- Major surgery on or within 28 days prior to randomization.
- Patient is unable or unwilling to comply with protocol-required study visits or procedures.
- Additional inclusion and exclusion criteria may apply
Where it is running
1 location listed across 1 US state.
- Florida Clinical Trials Group, LLC - Plantation, Florida, United States