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RASolve 301 (NCT06881784) is a multicenter, randomized, open-label Phase III trial comparing the oral pan-RAS(ON) inhibitor daraxonrasib (RMC-6236) versus intravenous docetaxel in adult patients with advanced, RAS-mutant non-small cell lung cancer (NSCLC) that is locally advanced or metastatic.
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The primary objectives are to evaluate progression-free survival (PFS) and overall survival (OS) in the RAS-mutant population (notably RAS G12X, excluding G12C).
Eligible patients must have histologically or cytologically confirmed NSCLC, measurable disease per RECIST v1.1, ECOG performance status 0–1, adequate organ function, documented RAS mutation (KRAS, NRAS, or HRAS codon 12, 13 or 61), and prior therapy with 1–2 lines including platinum-based chemotherapy and immune checkpoint inhibition.
Patients are randomized 1:1 to receive either daraxonrasib orally or docetaxel intravenously.
Key secondary endpoints include safety and tolerability, objective response rate (ORR), and PFS/OS in the overall RAS-mutant cohort.
The RASolve 301 study is testing a new drug called daraxonrasib (RMC-6236) against standard chemotherapy with docetaxel in adults with advanced non-small cell lung cancer (NSCLC) whose tumors have a mutation in the RAS gene.
The aim is to determine whether daraxonrasib can slow disease progression or extend survival.
Eligible participants are adults with locally advanced or metastatic NSCLC who have previously received one or two lines of therapy, including platinum-based chemotherapy and immunotherapy.
The RAS mutation status is confirmed before entering the trial.
Participants are randomly assigned to receive either daraxonrasib (oral) or docetaxel (intravenous).
The study also assesses how well patients tolerate the treatment and monitors disease outcome over time.
