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Studieoverzicht

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
NCT Id NCT06881784
Host / recruiting site 1 Amsterdam UMC Enrollment Recruiting
Host / recruiting site 2 MUMC+ Enrollment Recruiting
Host / recruiting site 3 Erasmus MC Enrollment Recruiting
Host / recruiting site 4 Antoni van Leeuwenhoek Enrollment Recruiting
Host / recruiting site 5 Radboud UMC Enrollment Recruiting
Host / recruiting site 6 UMC Groningen Enrollment Recruiting
Therapy line Later line (≥2L)
PD-L1 expression Low: 1 - 49%High: ≥50%
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)

(KRAS G12C, G13 en Q61 cohorts closed)
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).
  • Ongoing anticancer therapy.
  • Pregnancy and/or breastfeeding.
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