Study on Pembrolizumab, Pemetrexed, and Platinum Chemotherapy with or without Zoldonrasib for First-Line Treatment in Advanced Non-Squamous Lung Cancer with RAS G12D Mutation

Sponsor: Revolution Medicines, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT07777822

Provider View

This clinical trial is testing a new treatment combination for patients with advanced non-squamous non-small cell lung cancer (NSCLC) that has a specific genetic mutation called RAS G12D. The study aims to see if adding the investigational drug Zoldonrasib to standard chemotherapy and immunotherapy improves patient outcomes compared to standard treatment alone.

Patient Parameters

Program Overview

The goal of this study is to determine if adding the investigational drug Zoldonrasib to a combination of pembrolizumab and platinum-based chemotherapy can help patients with advanced non-squamous non-small cell lung cancer (NSCLC) that has a RAS G12D mutation live longer without their cancer getting worse. Participants will be randomly assigned to receive either the new combination treatment or a placebo along with the standard treatment.

Description

This is a Phase 3 study conducted worldwide to evaluate the effectiveness of Zoldonrasib when combined with pembrolizumab and platinum-based chemotherapy in treating patients with advanced non-squamous non-small cell lung cancer (NSCLC) that has a RAS G12D mutation. The study is double-blind, meaning neither the participants nor the researchers will know who is receiving the investigational drug or the placebo. Participants will be randomly assigned to one of two groups: one group will receive Zoldonrasib with pembrolizumab and chemotherapy, while the other group will receive a placebo with pembrolizumab and chemotherapy. The main goal is to see if the new treatment combination can help patients live longer without their cancer progressing compared to the standard treatment alone.

Eligibility Criteria

Inclusion Criteria

  • Must be at least 18 years old and have agreed to participate.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have a confirmed diagnosis of advanced non-squamous non-small cell lung cancer (NSCLC) that has not been treated before.
  • Have known PD-L1 status.
  • Have a documented RAS G12D mutation.
  • Have measurable cancer according to standard criteria.
  • Have adequate organ function, including bone marrow, liver, and kidneys.
  • Be able to take oral medications.

Exclusion Criteria

  • Have received previous treatment for advanced NSCLC.
  • Have been treated with any RAS-targeted therapy before.
  • Have untreated cancer that has spread to the brain or spinal cord.
  • Have any conditions that might affect the ability to take or absorb the study medication.
  • Have had major surgery within 28 days before starting the study.
  • Are unable or unwilling to attend study visits or follow study procedures.
  • Additional criteria may apply.

Locations

FACILITYZIPCITYSTATE
Florida Clinical Trials Group, LLC33322PlantationFlorida

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