Daraxonrasib after surgery for resected pancreatic ductal adenocarcinoma (PDAC)

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 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.

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.
* 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 it's running

• The University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Mayo Clinic
  Phoenix, Arizona, United States Recruiting
• HonorHealth Research Institute
  Scottsdale, Arizona, United States Recruiting
• UC San Diego Moores Cancer Center
  La Jolla, California, United States Recruiting
• Cedars-Sinai Cancer at Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• University of California, Los Angeles
  Los Angeles, California, United States Recruiting

+36 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Zoldonrasib plus Daraxonrasib vs Gemcitabine and Nab-Paclitaxel as first-line treatment for metastatic KRAS G12D pancreatic cancer

  This study tests whether two investigational RAS inhibitors together can improve outcomes compared with standard chemotherapy in adults with newly diagnosed metastatic pancreatic cancer carrying the KRAS G12D mutation.

  Recruiting at 6 sites Phase 3 Revolution Medicines, Inc. · Phoenix, Arizona and 5 other locations · NCT07805954

• Zoldonrasib + chemotherapy vs placebo + chemotherapy as first-line treatment for metastatic KRAS G12D pancreatic cancer

  This trial tests whether adding zoldonrasib to standard chemotherapy helps people with newly diagnosed metastatic KRAS G12D pancreatic cancer.

  Recruiting at 25 sites Phase 3 Revolution Medicines, Inc. · Phoenix, Arizona and 24 other locations · NCT07621718

• Atebimetinib plus gemcitabine and nab‑paclitaxel as first‑line treatment for metastatic pancreatic cancer

  This trial will test whether adding the MAPK pathway drug atebimetinib to gemcitabine and nab‑paclitaxel helps people with newly diagnosed metastatic pancreatic ductal adenocarcinoma live longer.

  Recruiting at 76 sites Phase 3 Immuneering Corporation · Huntsville, Alabama and 75 other locations · NCT07562152

• Daraxonrasib alone or with gemcitabine and nab-paclitaxel for first-line metastatic pancreatic cancer

  This trial will see if daraxonrasib, alone or with gemcitabine and nab-paclitaxel, helps people with newly diagnosed metastatic pancreatic cancer live longer or slow tumor growth compared with standard gemcitabine and nab-paclitaxel.

  Recruiting at 61 sites Phase 3 Revolution Medicines, Inc. · Phoenix, Arizona and 81 other locations · NCT07491445

• Registry for patients at high risk for pancreatic cancer

  This study is creating a registry for people at high risk of pancreatic cancer to see if new tests can help catch the disease early.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT06151223

• Screening for pancreatic cancer in high-risk individuals

  This study is testing if combining blood tests and symptom checks with regular screenings can help find pancreatic cancer earlier in people who are at higher risk because of their genetics.

  Recruiting Early Phase 1 Dana-Farber Cancer Institute · Boston, Massachusetts and 1 other locations · NCT06122896

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.