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RASolute 304: A Phase 3 Multicenter, Open-label, Randomized, 2-Arm Study of Adjuvant Daraxonrasib Versus Standard of Care Observation Following Completion of Neoadjuvant and/or Adjuvant Chemotherapy in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC)
(RASolute 304)

Phase 3 Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC) (RASolute 304)

Revolution Medicines, Inc.

IQVIA services Japan G.K.

4-10-18 Takanawa, Minato-ku,Tokyo 108-0074 Japan

JP-RMC-6236-304-jRCT@iqvia.com

IQVIA services Japan G.K. jRCT Call Center

IQVIA services Japan G.K.

4-10-18 Takanawa, Minato-ku,Tokyo 108-0074 Japan

+81-3-6859-9500

JP-RMC-6236-304-jRCT@iqvia.com

Recruiting

June. 01, 2026

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

- At least 18 years old and has provided informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Histologically confirmed PDAC with successful (R0/R1) curative intent surgical resection and no evidence of recurrent or metastatic disease.
- Must have received perioperative (neoadjuvant, adjuvant, or a combination of both) multi-agent chemotherapy.
- Must have completed most recent treatment within the past 12 weeks.
- Adequate organ function (bone marrow, liver, kidney, coagulation).
- Documented RAS mutation status.
- Able to take oral medications.

- Prior therapy with direct RAS-targeted therapy (eg. degraders and/or inhibitors).
- 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.

Both

Pancreatic Cancer
PDAC
Pancreatic Ductal Adenocarcinoma
Resected Pancreatic Adenocarcinoma

- Drug: daraxonrasib
-oral tablets

Pancreatic Cancer PDAC Pancreatic Ductal Adenocarcinoma RAS KRAS NRAS HRAS RAS Wild-Type RASolute Resectable Pancreatic Ductal Adenocarcinoma Resectable PDAC Resected Pancreatic Adenocarcinoma RAS Mutation

- Disease-Free Survival (DFS) per Investigator [Time Frame: Up to approximately 5 years]
-DFS defined as the time from randomization until disease recurrence or death from any cause, whichever occurs first. Recurrence is per response evaluation criteria in solid tumors (RECIST) v1.1 as assessed by Investigator.

Secondary Outcome Measure:
1. Overall survival (OS)
OS is defined as the time from randomization until death from any cause.
[Time Frame: Up to approximately 5 years]
2. DFS per blinded independent central review (BICR)
DFS defined as the time from randomization until disease recurrence or death from any cause, whichever occurs first. Progression is per RECIST v1.1 as assessed by BICR.
[Time Frame: Up to approximately 5 years]
3. DFS Rate at 1 year and 2 years
DFS rate defined as percentage of patients who are disease free at 1 year and 2 years, respectively.
[Time Frame: Up to approximately 5 years]
4. OS rate at 1 year and 2 years
OS rate defined as percentage of patients who are alive at 1 year and 2 years, respectively.
[Time Frame: Up to approximately 5 years]
5. Safety and tolerability of daraxonrasib
Incidence of adverse events (AEs) and changes from baseline in vital signs, ECOG performance score, and clinical laboratory tests.
[Time Frame: Up to approximately 5 years]
6. Pharmacokinetics (PK) characterization of daraxonrasib
Blood concentrations of daraxonrasib over time
[Time Frame: Up to approximately 5 years]

+81-45-520-2222

April. 06, 2026

No

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