Study name: RASolve 301 RMC-6236-301: Phase 3 Multicenter, Open Label, Randomized Study of RMC-6236 versus Docetaxel in Patients with Previously Treated Locally Advanced or Metastatic RAS[MUT] NSCLC
Histology
NSCLC, all subtypes
Tumor stage
Stage III - IV
Host / recruiting site 1
Amsterdam UMC
Enrollment
Planned
Host / recruiting site 2
MUMC+
Enrollment
Planned
Therapy line
Later line (≥2L)
Design
Treatment, Randomized, Parallel Assignment, Open Label The central reader of the tumor scans will be masked to the patients' treatment arm.
Intervention
Experimental: daraxonrasib study drug (oral tablets)
Active Comparator: docetaxel (intravenous infusion)
Key outcome parameters
Progression free survival (PFS) per Investigator in the RAS G12X-C population
Overall survival (OS) in the RAS G12X-C population
Key inclusion criteria
At least 18 years old and has provided informed consent.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Histologically confirmed NSCLC, either locally advanced or metastatic, not amenable to curative surgery or radiotherapy.
Measurable disease per RECIST v1.1.
Adequate organ function (bone marrow, liver, kidney, coagulation).
One to two prior lines of therapy including an anti-PD-1/anti-PD(L)-1 agent and platinum-based chemotherapy.
Documented RAS mutation status, defined as Nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61).
Able to take oral medications.
Key exclusion criteria
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).
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