Evaluating daraxonrasib for previously treated patients with RAS mutated lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This global, randomized, open-label Phase 3 study aims to assess the safety and efficacy of daraxonrasib, a novel RAS(ON) inhibitor, compared to standard docetaxel chemotherapy in patients with previously treated non-small cell lung cancer (NSCLC). Participants will be randomly assigned in a 1:1 ratio to receive either daraxonrasib or docetaxel. The primary focus is to determine if daraxonrasib can improve progression-free survival (PFS) or overall survival (OS) in this patient population. Eligible patients must have documented RAS mutations and measurable disease.

Why it matters

Who can join: the full rules

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.

Where it's running

• UC Irvine Health
  Orange, California, United States Recruiting
• Fondazione IRCCS Istituto Nazionale dei Tumori
  Milan, Milano, Italy Recruiting
• Azienda Socio Sanitaria Territoriale Niguarda
  Milan, Milano, Italy Recruiting
• Aichi Cancer Center Hospital
  Nagoya, Aichi-ken, Japan Recruiting
• Fujita Health University Hospital
  Toyoake-shi, Aichi-ken, Japan Recruiting
• National Cancer Center Hospital East
  Kashiwa-shi, Chiba, Japan Recruiting

+149 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Revolution Medicines Study Director
• Email: medinfo@revmed.com
• Phone: 1-844-2-REVMED

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.