A Phase 3 interventional study of daraxonrasib and docetaxel in NSCLC (Non-small Cell Lung Cancer), Non-Small Cell Lung Cancer and NSCLC, sponsored by Revolution Medicines, Inc.. Recruiting at 158 sites in 19 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Revolution Medicines, Inc. · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel.
This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with daraxonrasib will improve progression free survival (PFS) or overall survival (OS) compared to docetaxel chemotherapy in patients with NSCLC who were previously treated. Patients will be randomized in a 1:1 ratio to receive daraxonrasib or docetaxel chemotherapy.
Exclusion Criteria:
study drug
Drug: daraxonrasib
Patients randomized to the comparator control arm will receive docetaxel as the standard of care therapy.
Drug: docetaxel
oral tablets
intravenous (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.
Time frame: Up to approximately 4 years
Overall survival (OS) in the RAS G12X-C population
OS is defined as the time from randomization until death from any cause.
Time frame: Up to approximately 4 years
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.
Time frame: Up to approximately 4 years
OS in the RAS (MUT) population
OS is defined as time from randomization until death from any cause.
Time frame: up to approximately 4 years
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.
Time frame: Up to approximately 4 years
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.
Time frame: Up to approximately 4 years
Objective response per Investigator in the RAS (G12X-C) and RAS (MUT) populations
Objective response of PR or CR per RECIST v1.1 as assessed by Investigator.
Time frame: Up to approximately 4 years
Duration of response (DOR) per Investigator and per BICR in the RAS (G12X-C) and RAS (MUT) populations
DOR is defined as time from first evidence of objective response (PR or CR) to disease progression or death due to any cause, whichever occurs first, as assessed by Investigator and by BICR.
Time frame: Up to approximately 4 years
Time to response (TTR) per Investigator and per BICR in the RAS (G12X-C) and RAS (MUT) populations
TTR is defined as time from randomization to first evidence of objective response (PR or CR), as assessed by Investigator and by BICR.
Time frame: Up to approximately 4 years
Treatment effect on quality of life (QoL) using EORTC QLQ-LC13 In the RAS (G12X-C) and RAS (MUT) populations
Time to deterioration (TTD) in selected symptoms (dyspnea, chest pain, cough) defined as the time from randomization to the first onset of 10 points or more deterioration from baseline in the corresponding symptom scales (dyspnea, chest pain, cough) on European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire LC-13 (EORTC QLQ-LC13). Change from baseline on EORTC QLQ-LC13 in symptom scales (dyspnea, cough, chest pain).
Time frame: Up to approximately 4 years
Treatment effect on quality of life (QoL) using EORTC QLQ-C30 In the RAS (G12X-C) and RAS (MUT) populations
Change from baseline in global quality of life score from European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) questionnaire. Change from baseline on EORTC QLQ-C30 functioning domains (physical role, cognitive, emotional, social).
Time frame: Up to approximately 4 years
Safety and tolerability in the RAS (G12X-C) and RAS (MUT) population
Incidence of treatment emergent adverse events (TEAEs), treatment related adverse events (TRAEs), serious adverse events (SAEs), changes in vital signs and clinical laboratory tests.
Time frame: Up to approximately 4 years
PK characterization of daraxonrasib In the RAS (MUT) population
Predose and post-dose blood concentrations of daraxonrasib over time.
Time frame: Up to approximately 4 years
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Carcinoma, Non-Small-Cell Lung→
Revolution Medicines, Inc.