Study of Daraxonrasib (RMC-6236) in Previously Treated Patients With RAS Mutated NSCLC (RASolve 301)

Description

The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel.

Conditions

NSCLC (Non-small Cell Lung Cancer), Non-Small Cell Lung Cancer, NSCLC, NSCLC (Non-small Cell Lung Carcinoma), NSCLC (Advanced Non-small Cell Lung Cancer)

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Study Overview

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Study Details

Study overview

The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel.

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

Study of Daraxonrasib (RMC-6236) in Previously Treated Patients With RAS Mutated NSCLC (RASolve 301)

Condition
NSCLC (Non-small Cell Lung Cancer)
Intervention / Treatment

-

Contacts and Locations

Maumee

Taylor Cancer Research Center, Maumee, Ohio, United States, 43537

Salt Lake City

Utah Cancer Specialists, Salt Lake City, Utah, United States, 84106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Revolution Medicines, Inc.,

Study Record Dates

2030-12-01