Daraxonrasib alone or with gemcitabine and nab-paclitaxel for first-line metastatic pancreatic 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 is a global, randomized, open-label Phase 3 trial that randomizes patients with metastatic pancreatic adenocarcinoma to daraxonrasib alone, daraxonrasib plus gemcitabine and nab-paclitaxel, or standard gemcitabine and nab-paclitaxel. The primary goals are to compare progression-free survival and overall survival across the three arms. Eligible patients must have histologically confirmed metastatic PDAC, measurable disease, ECOG 0-1, documented RAS status, and no prior systemic therapy for metastatic disease. Treatment is given as first-line therapy and safety and tolerability will be monitored alongside efficacy outcomes.

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 or cytologically confirmed pancreatic adenocarcinoma.
* Diagnosis of metastatic disease ≤ 6 weeks prior to informed consent.
* Documented RAS mutation status, either mutant or wild-type.
* Measurable disease per RECIST v1.1.
* Adequate organ function (bone marrow, liver, kidney, coagulation).
* Able to take oral medications.

Exclusion Criteria:

* Prior treatment with systemic anticancer therapy in metastatic setting or prior RAS-targeted therapy in any treatment setting.
* Active or known history of untreated central nervous system metastatic disease.
* 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

• St. George Hospital
  Kogarah, New South Wales, Australia Recruiting
• Prince of Wales Hospital
  Randwick, New South Wales, Australia Recruiting
• Calvary Mater Newcastle
  Waratah, New South Wales, Australia Recruiting
• Royal Brisbane and Women's Hospital
  Herston, Queensland, Australia Recruiting
• Epworth HealthCare
  East Melbourne, Victoria, Australia Recruiting
• Austin Health, Olivia Newton-John Cancer Research & Wellness Centre
  Heidelberg, Victoria, Australia Recruiting

+32 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.

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  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

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

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• RMC-5127 for advanced cancers with KRAS G12V mutation

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  Recruiting at 9 sites Phase 1 Revolution Medicines, Inc. · New Haven, Connecticut and 8 other locations · NCT07349537

• Daraxonrasib after surgery for resected pancreatic ductal adenocarcinoma (PDAC)

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

  Recruiting at 85 sites Phase 3 Revolution Medicines, Inc. · Birmingham, Alabama and 85 other locations · NCT07252232

• TNG462 combined with RAS inhibitors or chemotherapy for MTAP‑loss pancreatic and RAS‑mutant lung cancer

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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.