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.

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Trial Title

RASolve301

Diagnosis

Lung cancer

Type of trial

Pharmaceutical

Type of treatement

Medical Oncology

Phase

III

Locations

Investigators

Principal Investigator
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