RASolve301
Phase 3 Multicenter, Open Label, Randomized Study of RMC-6236 versus Docetaxel in Patients with Previously Treated Unresectable or Metastatic NSCLC Harboring RAS Mutations.
Trial summary:
Phase 3 Multicenter, Open Label, Randomized Study of RMC-6236 versus Docetaxel in Patients with Previously Treated Unresectable or Metastatic NSCLC Harboring RAS Mutations.
Receptor status / problem studied:
NSCLC Harboring RAS Mutations
Inclusion criteria
- At least 18 years old and has provided informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Pathologically 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.
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.
- Pregnant or breastfeeding.
Open for recruitment
Trial Title
RASolve301
Diagnosis
Lung cancer
Type of trial
Pharmaceutical
Type of treatement
Medical Oncology
Phase
III
Investigators
Principal Investigator