Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma

Recruiting now · Phase 3

Conditions studied: Pancreatic Cancer, Pancreatic Cancer Metastatic, PDAC, PDAC - Pancreatic Ductal Adenocarcinoma, Pancreatic Ductal Adenocarcinoma (PDAC), Pancreatic Adenocarcinoma Metastatic, Pancreatic Adenocarcinoma, Pancreatic Adenosquamous Carcinoma

In brief

The purpose of this study is to evaluate the safety and efficacy of an investigational RAS(ON) inhibitor administered as monotherapy or in combination with chemotherapy, compared with standard of care (SOC) chemotherapy alone.

Key facts

Study ID

NCT07491445

Run by

Revolution Medicines, Inc.

People needed

900

Starts

2026-03-09

Expected to finish

2029-03-01

Last updated by the study team

2026-07-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Honor Health Research Institute — Scottsdale, Arizona, United States (enrolling)
• H Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States (enrolling)
• Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States (enrolling)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Comprehensive Cancer Centers of Nevada — Henderson, Nevada, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• University of Cincinnati Cancer Center — Cincinnati, Ohio, United States (enrolling)
• Taylor Cancer Research Center — Maumee, Ohio, United States (enrolling)
• SCRI Oncology Partners — Nashville, Tennessee, United States (enrolling)
• SCRI - Texas Oncology Dallas — Dallas, Texas, United States (enrolling)
• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Virginia Cancer Specialists — Fairfax, Virginia, United States (enrolling)
• Virginia Mason Medical Center — Seattle, Washington, United States (enrolling)
• Calvary Mater Newcastle — Waratah, New South Wales, Australia (enrolling)
• National Cancer Center - East — Kashiwa, Chiba, Japan (enrolling)
• Cancer Institute Hospital - Japan Foundation for Cancer Research — Koto-Ku, Tokyo, Japan (enrolling)
• NHO Kyushu Cancer Center — Fukuoka, Japan (enrolling)
• Kanagawa Cancer Canter — Kanagawa, Japan (enrolling)
• Wakayama Medical University Hospital — Wakayama, Japan (enrolling)
• Yamaguchi University Hospital — Yamaguchi, Japan (enrolling)

Full record on ClinicalTrials.gov

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