Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)
Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)

NCT06881784

RecruitingPhase 3

Sponsor: Revolution Medicines, Inc.

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)

Interventions: daraxonrasib, docetaxel

Countries: United States, Australia, Belgium, France, Germany, Hong Kong, Ireland, Italy

The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (152)
  • Birmingham, Alabama, United States
  • Long Beach, California, United States
  • New Haven, Connecticut, United States
  • Fort Myers, Florida, United States
  • Plantation, Florida, United States
  • Rockledge, Florida, United States
  • St. Petersburg, Florida, United States
  • Stuart, Florida, United States
  • West Palm Beach, Florida, United States
  • Athens, Georgia, United States
  • Atlanta, Georgia, United States
  • Atlanta, Georgia, United States
  • Chicago, Illinois, United States
  • Bettendorf, Iowa, United States
  • Iowa City, Iowa, United States
  • Waukee, Iowa, United States
  • Westwood, Kansas, United States
  • Baltimore, Maryland, United States
  • Detroit, Michigan, United States
  • Detroit, Michigan, United States
  • St Louis, Missouri, United States
  • Billings, Montana, United States
  • Lebanon, New Hampshire, United States
  • Hackensack, New Jersey, United States
  • Morristown, New Jersey, United States
  • Buffalo, New York, United States
  • New York, New York, United States
  • The Bronx, New York, United States
  • Chapel Hill, North Carolina, United States
  • Cincinnati, Ohio, United States
  • + 122 more on CT.gov