The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel.
At least 18 years old and has provided informed consent.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Pathologically confirmed NSCLC, either locally advanced or metastatic, not amenable to curative surgery or radiotherapy.
Measurable disease per RECIST v1.1.
Prior therapy with direct RAS-targeted therapy or docetaxel.
Untreated central nervous system (CNS) metastases.
Medically significant comorbidities (significant cardiovascular disease, lung disease, or impaired GI function).
Ongoing anticancer therapy.
Parallel
daraxonrasib
Drugoral tablets
docetaxel
Drugintravenous (IV) infusion
Progression free survival (PFS) per Blinded Independent Central Review (BICR) in the RAS G12X-C population (i.e RAS G12X excluding G12C)
PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per response evaluation criteria in solid tumors (RECIST) v1.1 and as assessed by BICR.
Overall survival (OS) in the RAS G12X-C population
OS is defined as the time from randomization until death from any cause.
PFS in the RAS (MUT) population per BICR
PFS is defined as time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per RECIST v1.1 as assessed by BICR.
OS in the RAS (MUT) population
OS is defined as time from randomization until death from any cause.
Objective response per BICR in the RAS (G12X-C) and RAS (MUT) populations
Objective response of partial response (PR) or complete response (CR) per RECIST v1.1 as assessed by BICR.
PFS per Investigator in the RAS (G12X-C) and RAS (MUT) populations
PFS is defined as time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per RECIST v1.1 as assessed by Investigator.
Click on the lead sponsor to view all of their trials.
