Zoldonrasib + chemotherapy vs placebo + chemotherapy as first-line treatment for metastatic KRAS G12D 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 Phase 3, randomized, double-blind study comparing zoldonrasib plus investigator’s choice chemotherapy (mFFX or GnP) to placebo plus investigator’s choice chemotherapy in previously untreated metastatic KRAS G12D pancreatic adenocarcinoma. Participants are assigned to Arm A or Arm B and receive either zoldonrasib or placebo in combination with chemotherapy selected by the investigator. The primary goals are to see if progression-free survival or overall survival improves with the zoldonrasib combination. Eligible patients have confirmed metastatic disease, measurable disease, ECOG 0–1, and adequate organ function, with KRAS G12D mutation documented. Key exclusions include prior systemic therapy for metastatic disease, prior RAS-targeted therapy, active CNS metastases, and conditions affecting drug absorption.

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 screening.
* Documented KRAS G12D mutation status.
* 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 unresectable locally advanced or metastatic setting.
* Prior systemic RAS-targeted therapy any time prior to randomization.
* Presence of other known driver mutations with approved targeted therapies
* 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

• Mayo Clinic Arizona
  Phoenix, Arizona, United States Recruiting
• The University of Arizona Cancer Center-North Campus
  Tucson, Arizona, United States Recruiting
• Yale University
  New Haven, Connecticut, United States Recruiting
• University of Florida
  Gainesville, Florida, United States Recruiting
• Mayo Clinic Florida
  Jacksonville, Florida, United States Recruiting
• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting

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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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.