The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to standard of care (SOC) observation only.
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.
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.
Parallel
daraxonrasib
Drugoral tablets
Disease-Free Survival (DFS) per Investigator
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.
Overall survival (OS)
OS is defined as the time from randomization until death from any cause.
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. Recurrence is per RECIST v1.1 as assessed by BICR.
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.
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.
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