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Daraxonrasib after surgery for resected pancreatic ductal adenocarcinoma (PDAC)

RASolute 304: A Phase 3 Multicenter, Open-label, Randomized, 2-Arm Study of Adjuvant Daraxonrasib Versus Standard of Care Observation Following Completion of Neoadjuvant and/or Adjuvant Chemotherapy in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC)

Phase 3 Interventional Revolution Medicines, Inc. · NCT07252232

This trial tests whether taking daraxonrasib after surgery can help prevent cancer from coming back in adults with resected PDAC who completed perioperative chemotherapy.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment500 (estimated)
Ages18 Years and up
SexAll
SponsorRevolution Medicines, Inc. Industry-sponsored
Drugs / interventionschemotherapy
Locations17 sites (Los Angeles, California and 16 other locations)
Trial IDNCT07252232 on ClinicalTrials.gov

What this trial studies

This is a randomized, open-label Phase 3 trial comparing oral daraxonrasib to standard observation in patients with resected pancreatic ductal adenocarcinoma who have completed neoadjuvant and/or adjuvant multi-agent chemotherapy. Eligible participants must have had curative-intent (R0/R1) resection, documented RAS mutation status, ECOG 0–1, and adequate organ function. The primary outcome is disease-free survival (DFS), with patients randomized to receive daraxonrasib or SOC observation and followed for recurrence and safety. The study is designed to test whether targeted inhibition of RAS signaling after surgery can reduce recurrence risk in this high-risk population.

Who should consider this trial

Good fit: Adults (≥18) with histologically confirmed PDAC who had a curative-intent (R0/R1) resection, documented RAS mutation, ECOG 0–1, completed perioperative multi-agent chemotherapy within the past 12 weeks, have adequate organ function, and can take oral medications are ideal candidates.

Not a fit: Patients with metastatic or recurrent disease, without a documented RAS mutation, who previously received direct RAS-targeted therapy, or who cannot take oral medication are unlikely to benefit from this study treatment.

Why it matters

Potential benefit: If successful, daraxonrasib could lengthen the time patients remain free of disease after surgery and reduce the chance of cancer recurrence.

How similar studies have performed: Early-phase studies of RAS-targeting agents have shown preliminary activity in RAS-mutant solid tumors, but using a RAS(ON) inhibitor as adjuvant therapy after resection for PDAC is novel and unproven.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 PDAC with successful (R0/R1) curative intent surgical resection and no evidence of recurrent or metastatic disease.
* Must have received perioperative (neoadjuvant, adjuvant, or a combination of both) multi-agent chemotherapy.
* Must have completed most recent treatment within the past 12 weeks.
* Adequate organ function (bone marrow, liver, kidney, coagulation).
* Documented RAS mutation status.
* Able to take oral medications.

Exclusion Criteria:

* Prior therapy with direct RAS-targeted therapy (eg. degraders and/or inhibitors).
* Any conditions that may affect the ability to take or absorb study drug.
* Major surgery within 28 days prior to randomization.
* Patient is unable or unwilling to comply with protocol-required study visits or procedures.

Where this trial is running

Los Angeles, California and 16 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Pancreatic CancerPDACPDAC - Pancreatic Ductal AdenocarcinomaResectable Pancreatic Ductal AdenocarcinomaResected Pancreatic AdenocarcinomaPancreatic Ductal AdenocarcinomaRASKRAS
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.