Study on Daraxonrasib for Previously Treated Patients with RAS Mutated Non-Small Cell Lung Cancer (NSCLC)

Sponsor: Revolution Medicines, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT06881784

This clinical trial is testing a new drug, daraxonrasib, to see if it is safer and more effective than the standard chemotherapy drug, docetaxel, for patients with RAS mutated non-small cell lung cancer (NSCLC) who have already received treatment.

Patient Parameters

Program Overview

The study aims to find out if the new drug daraxonrasib can help patients with RAS mutated non-small cell lung cancer (NSCLC) live longer or have more time without their cancer getting worse, compared to the standard chemotherapy drug, docetaxel. Participants will be randomly assigned to receive either daraxonrasib or docetaxel to compare the outcomes.

Description

This is a Phase 3 clinical trial that will take place in multiple locations around the world. The study is open-label, meaning both the doctors and participants know which treatment is being given. Participants will be randomly divided into two groups: one group will receive the new drug daraxonrasib, and the other group will receive the standard chemotherapy drug, docetaxel. The main goal is to see if daraxonrasib can help patients live longer or delay the progression of their cancer compared to docetaxel. The study will closely monitor the safety and effectiveness of daraxonrasib in these patients.

Eligibility Criteria

Inclusion Criteria

  • Must be at least 18 years old and agree to participate in the study.
  • Must be in good general health, able to carry out normal activities or light work.
  • Must have a confirmed diagnosis of non-small cell lung cancer (NSCLC) that is advanced or has spread and cannot be treated with surgery or radiation.
  • Must have cancer that can be measured by scans.
  • Must have good organ function, including bone marrow, liver, and kidneys.
  • Must have received one or two previous treatments, including a type of immunotherapy and platinum-based chemotherapy.
  • Must have a specific RAS gene mutation in their cancer.
  • Must be able to take oral medications.

Exclusion Criteria

  • Have previously received treatment that directly targets RAS or have been treated with docetaxel.
  • Have untreated cancer that has spread to the brain or spinal cord.
  • Have serious health conditions affecting the heart, lungs, or digestive system.
  • Are currently receiving any other cancer treatment.
  • Are pregnant or breastfeeding.

Locations

FACILITYZIPCITYSTATE
Taylor Cancer Research Center43537MaumeeOhio
SCRI Oncology Partners - Tennessee37203NashvilleTennessee
Utah Cancer Specialists84106Salt Lake CityUtah
Virginia Cancer Specialists22031FairfaxVirginia

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