Study of Pembrolizumab + Pemetrexed + Platinum Chemotherapy With or Without Zoldonrasib as First Line Treatment in Metastatic Non-squamous RAS G12D-Mutated NSCLC
Part of paid clinical trials in Plantation, Florida.
- Sponsor
- Revolution Medicines, Inc.
- Study ID
- NCT07777822
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- Lung Cancer (NSCLC)
- Metastatic NSCLC - Non-Small Cell Lung Cancer
- Metastatic Non-Squamous Non-Small Cell Lung Cancer
- NSCLC
- Non-Small Cell Lung Cancer NSCLC
- Non-Squamous Non Small Cell Lung Cancer
- Non-small Cell Lung Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- zoldonrasib — DRUGoral tablets
- Placebo — DRUGoral tablets
- pembrolizumab — DRUGIV infusion or Subcutaneous injection
- pemetrexed + cisplatin /carboplatin — DRUGIV infusion of either pemetrexed + cisplatin or pemetrexed + carboplatin
Study Details
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.
Key Dates
- First listed
- Aug 20, 2026
- Start date
- Aug 14, 2026
- Status verified
- Aug 2026
- Primary completion
- Oct 31, 2029
- Completion
- Feb 28, 2031
Study Design
- Enrollment
- 430 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm A: zoldonrasib + pembrolizumab + chemotherapy doubletstudy drug in combination with pembrolizumab and platinum-based chemotherapy doublet
- Placebo Comparator: Arm B: placebo + pembrolizumab + chemotherapy doubletplacebo in combination with pembrolizumab and platinum-based chemotherapy doublet
Primary Outcome Measure
Progression free survival (PFS) [ Time Frame: Up to approximately 5 years ]
Central Contacts
- Revolution Medicines Study Director1-844-2-REVMED
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Florida Clinical Trials Group, LLC | Plantation | Florida | 33322 |
Find similar trials in Plantation, FL
By condition
By specialty
By research site
Related Studies
- JoLT-Ca Sublobar Resection (SR) Versus Stereotactic Ablative Radiotherapy (SAbR) for Lung CancerPHASE3 · Recruiting · University of Texas Southwestern Medical Center · Savannah, Georgia
- APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid TumorsPHASE2 · Recruiting · Apollomics Inc. · Los Angeles, California
- A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid TumorsPHASE1/PHASE2 · Recruiting · Merus B.V. · La Jolla, California
- VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or LymphomaPHASE1/PHASE2 · Recruiting · VM Oncology, LLC · Santa Rosa, California