Recruiting

RASolve 301RMC-6236 for Advanced RAS-Mutated NSCLC

What is being tested

daraxonrasib

+ docetaxel

Drug

Who is being recruted

Bronchial Neoplasms+7

+ Carcinoma, Bronchogenic

+ Carcinoma, Non-Small-Cell Lung

Over 18 Years

+13 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: May 2025

See protocol details

Summary

Principal SponsorRevolution Medicines, Inc.

Study ContactRevolution Medicines Study Director

Last updated: March 13, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: May 6, 2025

Actual date on which the first participant was enrolled.

This study focuses on patients with a type of lung cancer known as non-small cell lung cancer (NSCLC) that has either advanced locally or spread to other parts of the body. These patients have already tried other treatments. The study is conducted to see if a new treatment called daraxonrasib can help patients live longer without their cancer getting worse compared to a standard chemotherapy drug called docetaxel. This research is crucial because finding more effective treatments can improve the quality of life and survival rates for people with this challenging condition. Participants in the study will be randomly assigned to receive either daraxonrasib or docetaxel. Daraxonrasib is given to see if it can better control cancer growth. The study will measure how long patients live without their cancer progressing and overall survival time. This will help determine which treatment is more effective. By participating, patients contribute to advancing cancer treatment, potentially leading to improved options for future patients.

Official TitleRASolve 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

Principal SponsorRevolution Medicines, Inc.

Study ContactRevolution Medicines Study Director

Last updated: March 13, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

420 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic Neoplasms

Criteria

8 inclusion criteria required to participate

Pathologically confirmed NSCLC, either locally advanced or metastatic, not amenable to curative surgery or radiotherapy

Measurable disease per RECIST v1.1

At least 18 years old and has provided informed consent

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Show More Criteria

5 exclusion criteria prevent from participating

Pregnant or breastfeeding

Untreated central nervous system (CNS) metastases

Medically significant comorbidities (significant cardiovascular disease, lung disease, or impaired GI function)

Prior therapy with direct RAS-targeted therapy or docetaxel

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

study drug

Group II

Active Comparator

Patients randomized to the comparator control arm will receive docetaxel as the standard of care therapy.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 129 locations

Recruiting

Alabama Oncology

Birmingham, United StatesOpen Alabama Oncology in Google Maps

Recruiting

MemorialCare Long Beach Medical Center

Long Beach, United States

Recruiting

Yale University, Smillow Cancer Center

New Haven, United States

Recruiting

Florida Cancer Specialists & Research Institute - South

Fort Myers, United States

Recruiting

129 Study Centers