Study of Daraxonrasib (RMC-6236) in Previously Treated Patients With RAS Mutated NSCLC (RASolve 301)
Purpose
The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel.
Conditions
- NSCLC (Non-small Cell Lung Cancer)
- Non-Small Cell Lung Cancer
- NSCLC
- NSCLC (Non-small Cell Lung Carcinoma)
- NSCLC (Advanced Non-small Cell Lung Cancer)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- At least 18 years old and has provided informed consent. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Histologically confirmed NSCLC, either locally advanced or metastatic, not amenable to curative surgery or radiotherapy. - Measurable disease per RECIST v1.1. - Adequate organ function (bone marrow, liver, kidney, coagulation). - One to two prior lines of therapy including an anti-PD-1/anti-PD(L)-1 agent and platinum-based chemotherapy. - Documented RAS mutation status, defined as Nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61). - Able to take oral medications.
Exclusion Criteria
- Prior therapy with direct RAS-targeted therapy or docetaxel. - Untreated central nervous system (CNS) metastases. - Medically significant comorbidities (significant cardiovascular disease, lung disease, or impaired GI function). - Ongoing anticancer therapy. - Pregnancy and/or breastfeeding.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
- Masking Description
- The central reader of the tumor scans will be masked to the patients' treatment arm.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental daraxonrasib |
study drug |
|
|
Active Comparator docetaxel |
Patients randomized to the comparator control arm will receive docetaxel as the standard of care therapy. |
|
Recruiting Locations
Washington University in St. Louis and nearby locations
Washington University School of Medicine - Siteman Cancer Center
St Louis 4407066, Missouri 4398678 63110
St Louis 4407066, Missouri 4398678 63110
More Details
- NCT ID
- NCT06881784
- Status
- Recruiting
- Sponsor
- Revolution Medicines, Inc.
Detailed Description
This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with daraxonrasib will improve progression free survival (PFS) or overall survival (OS) compared to docetaxel chemotherapy in patients with NSCLC who were previously treated. Patients will be randomized in a 1:1 ratio to receive daraxonrasib or docetaxel chemotherapy.