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NCT Number: NCT06881784

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

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

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Key information

Conditions

NSCLC (Non-small Cell Lung Cancer) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms NSCLC NSCLC (Advanced Non-small Cell Lung Cancer) NSCLC (Non-small Cell Lung Carcinoma) Neoplasms Neoplasms by Site Non-small Cell Lung Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Blacktown Medical Oncology Research, Blacktown, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

daraxonrasib

Drug

oral tablets

docetaxel

Drug

intravenous (IV) infusion

Primary outcomes

  1. 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

    PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per response evaluation criteria in solid tumors (RECIST) v1.1 and as assessed by BICR.

  2. Overall survival (OS) in the RAS G12X-C population

    Time frame: Up to approximately 4 years

    OS is defined as the time from randomization until death from any cause.

Secondary outcomes

  1. PFS in the RAS (MUT) population per BICR

    Time frame: Up to approximately 4 years

    PFS is defined as time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per RECIST v1.1 as assessed by BICR.

  2. OS in the RAS (MUT) population

    Time frame: up to approximately 4 years

    OS is defined as time from randomization until death from any cause.

  3. Objective response per BICR in the RAS (G12X-C) and RAS (MUT) populations

    Time frame: Up to approximately 4 years

    Objective response of partial response (PR) or complete response (CR) per RECIST v1.1 as assessed by BICR.

  4. PFS per Investigator in the RAS (G12X-C) and RAS (MUT) populations

    Time frame: Up to approximately 4 years

    PFS is defined as time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per RECIST v1.1 as assessed by Investigator.

  5. Objective response per Investigator in the RAS (G12X-C) and RAS (MUT) populations

    Time frame: Up to approximately 4 years

    Objective response of PR or CR per RECIST v1.1 as assessed by Investigator.

  6. 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

    DOR is defined as time from first evidence of objective response (PR or CR) to disease progression or death due to any cause, whichever occurs first, as assessed by Investigator and by BICR.

  7. 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

    TTR is defined as time from randomization to first evidence of objective response (PR or CR), as assessed by Investigator and by BICR.

  8. 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

    Time to deterioration (TTD) in selected symptoms (dyspnea, chest pain, cough) defined as the time from randomization to the first onset of 10 points or more deterioration from baseline in the corresponding symptom scales (dyspnea, chest pain, cough) on European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire LC-13 (EORTC QLQ-LC13).

    Change from baseline on EORTC QLQ-LC13 in symptom scales (dyspnea, cough, chest pain).

  9. 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

    Change from baseline in global quality of life score from European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) questionnaire.

    Change from baseline on EORTC QLQ-C30 functioning domains (physical role, cognitive, emotional, social).

  10. Safety and tolerability in the RAS (G12X-C) and RAS (MUT) population

    Time frame: Up to approximately 4 years

    Incidence of treatment emergent adverse events (TEAEs), treatment related adverse events (TRAEs), serious adverse events (SAEs), changes in vital signs and clinical laboratory tests.

  11. PK characterization of daraxonrasib In the RAS (MUT) population

    Time frame: Up to approximately 4 years

    Predose and post-dose blood concentrations of daraxonrasib over time.

Study contacts

Contact information is provided by the study sponsor or research team.

Revolution Medicines Study Director

CONTACT

[email protected]

1-844-2-REVMED

Sponsors and collaborators

Lead sponsor

Revolution Medicines, Inc.

Industry

Registry information

Official study 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

Acronym: RASolve 301

Important dates

Study start
2025
Primary completion
2027
Study completion
2030
First posted
Mar 18, 2025
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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