Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 3
Revolution Medicines, Inc. (Voir sur ClinicalTrials)
mai 2025
décembre 2030
02 décembre 2025
The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON)
inhibitor compared to docetaxel.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Christos CHOUAID | 24/11/2025 17:05:02 | Contacter | ||
Critères
Tous
- 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.