Study on New RAS(ON) Inhibitor Combinations for Patients with Advanced RAS-Mutated Non-Small Cell Lung Cancer

Sponsor: Revolution Medicines, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06162221

Provider View

This clinical trial is testing new drug combinations that target RAS mutations in patients with advanced non-small cell lung cancer (NSCLC). The study aims to find out if these combinations are safe and effective in treating the cancer.

Patient Parameters

Program Overview

The goal of this study is to evaluate the safety and effectiveness of new RAS(ON) inhibitors when used with standard cancer treatments or with each other in patients with advanced RAS-mutated non-small cell lung cancer (NSCLC). The study is divided into two parts, each testing different drug combinations to see how well they work against tumors.

Description

This study is designed to test new treatments for patients with advanced cancers that have specific RAS mutations, focusing on non-small cell lung cancer (NSCLC). The study is open-label, meaning both the researchers and participants know which treatments are being given. It is divided into two main parts:

  • Subprotocol A: This part tests a drug called RMC-6291 combined with pembrolizumab, a type of immunotherapy, with or without chemotherapy, in patients with KRAS G12C-mutated advanced solid tumors.

  • Subprotocol B: This part tests a drug called RMC-6236 combined with pembrolizumab, with or without chemotherapy, in patients with RAS-mutated NSCLC.

Each part of the study has two phases:

  1. Dose Exploration: This phase is to find the best dose of the drug combinations.
  2. Dose Expansion: This phase tests the effectiveness of the best dose found in the first phase.

The study aims to determine the safest and most effective dose and schedule for these new drug combinations.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have good organ function as determined by the study.
  • Have received previous standard treatment suitable for their cancer type and stage.
  • For Subprotocol A: Must have a confirmed diagnosis of a KRAS G12C-mutated solid tumor that cannot be removed by surgery.
  • For Subprotocol B: Must have a confirmed diagnosis of RAS-mutated non-small cell lung cancer (NSCLC).

Exclusion Criteria

  • Have primary tumors in the central nervous system (CNS).
  • Have gastrointestinal (GI) issues that could affect the absorption of the study drugs.
  • Have had major surgery within 28 days before the first dose of the study drug.
  • Have active or a history of lung diseases like interstitial lung disease (ILD) or pneumonitis that required steroid treatment.

Other criteria may apply.

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