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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• daraxonrasib — DRUG
  oral tablets
• docetaxel — DRUG
  intravenous (IV) infusion

Study Details

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

Key Dates

Start date

May 6, 2025

Status verified

May 2026

Primary completion

Dec 1, 2027

Completion

Dec 1, 2030

Study Design

Enrollment

590 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: daraxonrasib
  study drug
• Active Comparator: docetaxel
  Patients randomized to the comparator control arm will receive docetaxel as the standard of care therapy.

Primary Outcome Measure

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 ]

Central Contacts

• Revolution Medicines Study Director
  1-844-2-REVMED
  [email protected]

Locations (39)

Find similar trials in Birmingham, AL

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