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

Revolution Medicines

Status and phase: Enrolling; Phase 3

Conditions: NSCLC (Advanced Non-small Cell Lung Cancer); NSCLC (Non-small Cell Lung Cancer); NSCLC (Non-small Cell Lung Carcinoma); NSCLC; Non-Small Cell Lung Cancer

Treatments: Drug: daraxonrasib; Drug: docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT06881784

RMC-6236-301

Details and patient eligibility

About

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

Full description

This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with daraxonrasib will improve progression free survival (PFS) or overall survival (OS) compared to docetaxel chemotherapy in patients with NSCLC who were previously treated. Patients will be randomized in a 1:1 ratio to receive daraxonrasib or docetaxel chemotherapy.

Enrollment: 420 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion 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.

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.
• Pregnancy and/or breastfeeding.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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420 participants in 2 patient groups

daraxonrasib

Experimental group

Description:

study drug

Treatment:

Drug: daraxonrasib

docetaxel

Active Comparator group

Description:

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

Treatment:

Drug: docetaxel