RASolve 301: Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)

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.

OS is defined as time from randomization until death from any cause.

Objective response of partial response (PR) or complete response (CR) per RECIST v1.1 as assessed by Investigator.

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 blinded independent central review (BICR).

Objective response of PR or CR per RECIST v1.1 as assessed by BICR.

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.

TTR is defined as time from randomization to first evidence of objective response (PR or CR), as assessed by Investigator and by BICR.

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).

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).

Incidence of treatment emergent adverse events (TEAEs), treatment related adverse events (TRAEs), serious adverse events (SAEs), changes in vital signs and clinical laboratory tests.

Blood concentrations of daraxonrasib over time.