RASolve 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 (NCT06881784)

Global, open-label, Phase 3 study, patients with locally advanced or metastatic RAS-mutant NSCLC will be randomized to RMC-6236 or docetaxel (in a 1:1 ratio) on a 21-day treatment cycle.

Trial phase

Phase 3

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Dr Ben Markman

Key inclusion data

Age 18 years or older; NSCLC (Histologically confirmed NSCLC, either locally advanced or metastatic, not amenable to curative surgery or radiotherapy); RAS Mutation (Nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61)); Prior Therapy (Prior therapy for advanced disease must be limited to 1 or 2 prior lines of therapy and must include an anti-PD-1/anti-PD(L)-1 agent and a platinum-based chemotherapy. Prior therapy with any RAS inhibitor, including a KRAS G12C inhibitor, is prohibited. Adjuvant therapy or multimodal therapy with curative intent is considered prior therapy if disease progression occurred on or within 6 months of treatment completion).