Revolution Medicines starts Phase 3 first-line pancreatic cancer combination trial

Revolution Medicines has started enrolling patients in RASolute 309, a global randomized Phase 3 study in metastatic RAS G12D pancreatic adenocarcinoma. The study tests RASONQUE, or daraxonrasib, with investigational drug zoldonrasib as an initial treatment against gemcitabine plus nab-paclitaxel. Its co-primary measures are progression-free survival and overall survival.

The trial moves Revolution Medicines' RASONQUE-zoldonrasib combination into a late-stage first-line setting. The company says earlier clinical findings in previously treated metastatic disease showed antitumor activity with manageable safety, but the Phase 3 study will determine comparative efficacy and survival outcomes.

  • 1Revolution Medicines began treating patients in the global randomized, open-label Phase 3 RASolute 309 trial on Oct. 05, 2026.
  • 2RASolute 309 compares RASONQUE plus zoldonrasib with gemcitabine and nab-paclitaxel for adults receiving first-line treatment for metastatic RAS G12D pancreatic adenocarcinoma.
  • 3The study's dual primary endpoints are progression-free survival and overall survival.
  • 4RASolute 309 is identified as NCT07805954.
  • 5RASONQUE received U.S. FDA approval in August 2026 for certain adults with metastatic pancreatic adenocarcinoma.
  • 6Zoldonrasib remains investigational and has no regulatory approvals, according to the report.

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