Clinical Trials in the UK / NCT06881784
Recruiting
Phase 3
Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)
NCT06881784 · tracked via the Priya Life Science UK tracker
Condition(s) studied
NSCLC (Non-small Cell Lung Cancer)Non-Small Cell Lung CancerNSCLCNSCLC (Non-small Cell Lung Carcinoma)NSCLC (Advanced Non-small Cell Lung Cancer)
Investigational drug(s) / intervention(s)
daraxonrasib: oral tablets
docetaxel: intravenous (IV) infusion
Study summary
The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel.
Eligibility
Inclusion Criteria:
* At least 18 years old and has provided informed consent.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Pathologically 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.
* Pregnant or breastfeeding.
Primary outcome measure(s)
- Progression free survival (PFS) per Blinded Independent Central Review (BICR) in the RAS G12X-C population (i.e RAS G12X excluding G12C) — Up to approximately 4 years
PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per response evaluation criteria in solid tumors (RECIST) v1.1 and as assessed by BICR. - Overall survival (OS) in the RAS G12X-C population — Up to approximately 4 years
OS is defined as the time from randomization until death from any cause.
Trial sites (158)
| Facility | City | Region | Status |
|---|---|---|---|
| Alabama Oncology | Birmingham | Alabama | Recruiting |
| MemorialCare Long Beach Medical Center | Long Beach | California | Recruiting |
| Yale University, Smillow Cancer Center | New Haven | Connecticut | Recruiting |
| Florida Cancer Specialists & Research Institute - South | Fort Myers | Florida | Recruiting |
| BRCR Global | Plantation | Florida | Recruiting |
| Cancer Care Centers of Breevard | Rockledge | Florida | Recruiting |
| Florida Cancer Specialists & Research Institute - North | St. Petersburg | Florida | Recruiting |
| Cleveland Clinic Martin North | Stuart | Florida | Recruiting |
| Florida Cancer Specialists & Research Institute - East | West Palm Beach | Florida | Recruiting |
| University Cancer and Blood Center | Athens | Georgia | Recruiting |
| Piedmont Healthcare, Inc | Atlanta | Georgia | Recruiting |
| Winship Cancer Institute | Atlanta | Georgia | Recruiting |
| University of Illinois Cancer Center | Chicago | Illinois | Recruiting |
| Center for Care and Discovery | Chicago | Illinois | Recruiting |
| University of Iowa Health Care Cancer Services Quad Cities | Bettendorf | Iowa | Recruiting |
| University of Iowa Hospitals & Clinics | Iowa City | Iowa | Recruiting |
| University of Iowa Health Care, Mission Cancer + Blood | Waukee | Iowa | Recruiting |
| The University of Kansas Cancer Center | Westwood | Kansas | Recruiting |
| Johns Hopkins University of Medicine | Baltimore | Maryland | Recruiting |
| Trinity Health Ann Arbor Hospital | Ann Arbor | Michigan | Recruiting |
| Karmanos Cancer Institute | Detroit | Michigan | Recruiting |
| Henry Ford Health | Detroit | Michigan | Recruiting |
| Washington University School of Medicine - Siteman Cancer Center | St Louis | Missouri | Recruiting |
| St. Vincent Frontier Cancer Center | Billings | Montana | Recruiting |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | Recruiting |
| John Theurer Cancer Center at Hackensack UMC | Hackensack | New Jersey | Recruiting |
| Morristown Medical Center (MMCORC) | Morristown | New Jersey | Recruiting |
| Roswell Park Cancer Institute | Buffalo | New York | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | Recruiting |
| Montefiore Medical Center | The Bronx | New York | Recruiting |
| UNC Lineberger Comprehensive Cancer Center at University of North Carolina | Chapel Hill | North Carolina | Recruiting |
| TriHealth Cancer & Blood Institute Research | Cincinnati | Ohio | Recruiting |
| Taylor Cancer Research Center | Maumee | Ohio | Recruiting |
| Oncology Associates of Oregon PC | Eugene | Oregon | Recruiting |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | Recruiting |
| Avera Saint Luke's Hospital | Aberdeen | South Dakota | Recruiting |
| Avera Cancer Institute | Sioux Falls | South Dakota | Recruiting |
| SCRI Oncology Partners - Tennessee | Nashville | Tennessee | Recruiting |
| Texas Oncology - South Austin | Austin | Texas | Recruiting |
| Texas Oncology Dallas | Dallas | Texas | Recruiting |
+ 118 more sites — see the full list on the official registry below.
More Revolution Medicines, Inc. trials in the UK
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A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001)
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06881784 on ClinicalTrials.gov ↗ ← All trials in the UK