Study Comparing Savolitinib and Osimertinib with Savolitinib and Placebo in Patients with Advanced Lung Cancer

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT04606771

Provider View

This clinical trial is testing two treatment combinations for patients with advanced non-small cell lung cancer (NSCLC) that has specific genetic changes. The study aims to see if adding savolitinib to osimertinib is more effective than using savolitinib with a placebo.

Patient Parameters

Program Overview

The purpose of this study is to compare two treatment combinations for patients with advanced non-small cell lung cancer (NSCLC) that has specific genetic changes, including an EGFR mutation and MET amplification. Researchers want to find out if combining savolitinib with osimertinib is more effective than combining savolitinib with a placebo. This study is for patients whose cancer has progressed after treatment with osimertinib. Participants will be randomly assigned to receive either savolitinib with osimertinib or savolitinib with a placebo, and the study will monitor their response to the treatment.

Description

This study addresses a common issue where lung cancer becomes resistant to a treatment called osimertinib. This resistance can happen due to changes in the cancer cells, specifically an increase in a protein called MET. The study will test if adding a drug called savolitinib to osimertinib can help overcome this resistance. Participants will be randomly assigned to receive either savolitinib with osimertinib or savolitinib with a placebo. The study will be conducted in multiple centers and is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving which treatment. Treatment will continue in 28-day cycles until the cancer progresses, side effects become too severe, or the participant decides to stop. If the cancer progresses, participants who were receiving the placebo may switch to the savolitinib and osimertinib combination.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older (20 years or older in Japan).
  • Have advanced non-small cell lung cancer (NSCLC) with specific genetic changes that make it sensitive to EGFR TKI treatment.
  • Cancer must have progressed after treatment with osimertinib.
  • Have MET amplification confirmed by testing.
  • Have at least one measurable tumor.
  • Have received 1 to 3 previous treatments for advanced cancer.
  • Have good blood, liver, and kidney function.
  • Be in good overall health with a life expectancy of at least 12 weeks.
  • Women of childbearing potential must use effective birth control and have a negative pregnancy test.
  • Men must use barrier contraception and avoid donating sperm during and for 6 months after treatment.

Exclusion Criteria

  • Have unresolved side effects from previous treatments, except for certain conditions like hair loss.
  • Have active digestive issues that affect medication absorption.
  • Have certain heart conditions or high blood pressure that is not controlled.
  • Have had recent major surgery or radiation therapy.
  • Have severe or uncontrolled diseases that could interfere with the study.
  • Have active hepatitis B or C, or serious infections like tuberculosis or HIV.
  • Have other active cancers or a history of invasive cancer within the last 5 years.
  • Have brain or spinal cord issues unless stable and not requiring steroids.
  • Have a history of lung diseases that required steroid treatment.
  • Have been treated with certain other cancer drugs or participated in another clinical trial recently.
  • Are taking medications that affect how the study drugs work.

Locations

FACILITYZIPCITYSTATE
Research Site91010DuarteCalifornia
Research Site95817SacramentoCalifornia

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.