Recruiting NCT06881784

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

Phase III Interventional NSCLC (Non-small Cell Lung Cancer) Non-Small Cell Lung Cancer NSCLC NSCLC (Non-small Cell Lung Carcinoma)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: daraxonrasib, docetaxel.
Who it may be relevant to: Registry conditions: NSCLC (Non-small Cell Lung Cancer), Non-Small Cell Lung Cancer, NSCLC, NSCLC (Non-small Cell Lung Carcinoma). Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, Belgium, France, Germany +14
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed 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.

Interventions

Drug daraxonrasib
oral tablets
Drug docetaxel
intravenous (IV) infusion

Primary outcome measures

Progression free survival (PFS) per Blinded Independent Central Review (BICR) in the RAS G12X-C population (i.e RAS G12X excluding G12C) [Time frame: Up to approximately 4 years]
Overall survival (OS) in the RAS G12X-C population [Time frame: Up to approximately 4 years]

Secondary outcome measures (11)

PFS in the RAS (MUT) population per BICR [Time frame: Up to approximately 4 years]
OS in the RAS (MUT) population [Time frame: up to approximately 4 years]
Objective response per BICR in the RAS (G12X-C) and RAS (MUT) populations [Time frame: Up to approximately 4 years]
PFS per Investigator in the RAS (G12X-C) and RAS (MUT) populations [Time frame: Up to approximately 4 years]
Objective response per Investigator in the RAS (G12X-C) and RAS (MUT) populations [Time frame: Up to approximately 4 years]
Duration of response (DOR) per Investigator and per BICR in the RAS (G12X-C) and RAS (MUT) populations [Time frame: Up to approximately 4 years]
Time to response (TTR) per Investigator and per BICR in the RAS (G12X-C) and RAS (MUT) populations [Time frame: Up to approximately 4 years]
Treatment effect on quality of life (QoL) using EORTC QLQ-LC13 In the RAS (G12X-C) and RAS (MUT) populations [Time frame: Up to approximately 4 years]
Treatment effect on quality of life (QoL) using EORTC QLQ-C30 In the RAS (G12X-C) and RAS (MUT) populations [Time frame: Up to approximately 4 years]
Safety and tolerability in the RAS (G12X-C) and RAS (MUT) population [Time frame: Up to approximately 4 years]
PK characterization of daraxonrasib In the RAS (MUT) population [Time frame: Up to approximately 4 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment