Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )

NCT07621718 · RASolute 305 Phase 3Recruiting

Lead sponsor
Revolution Medicines, Inc. (Industry)
Enrollment
670 (estimated)
Start date
22 May 2026
Primary completion
30 Dec 2028 (estimated)
Study completion
22 Apr 2030
Last update posted
13 Oct 2026

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
Double
Arms
2

Interventions

  • Zoldonrasib Drug
  • Placebo Drug
  • Oxaliplatin Drug
  • Leucovorin (Calcium Folinate) Drug
  • 5-Fluorouracil Drug
  • Irinotecan Drug
  • Gemcitabine (GEM) Drug
  • Nab-paclitaxel Drug

Conditions and primary outcome

  • Pancreatic Cancer
  • Pancreatic Cancer Metastatic
  • PDAC
  • PDAC - Pancreatic Ductal Adenocarcinoma
  • Pancreatic Ductal Adenocarcinoma (PDAC)
  • Pancreatic Adenocarcinoma Metastatic
  • Pancreatic Adenocarcinoma
  • Pancreatic Adenosquamous Carcinoma

Primary outcome

Progression free survival (PFS) (Up to approximately 4 years); Overall survival (OS) (Up to approximately 4 years)

Posted results on ClinicalTrials.gov

Results posted on ClinicalTrials.gov: No

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

No PubMed citation lists NCT07621718.

CT-VCA trial quality

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Data integrity

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Drugs on HealthTrade

Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

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