Study on Savolitinib and Osimertinib Compared to Standard Chemotherapy for Non-Small Cell Lung Cancer After Osimertinib Treatment
Sponsor: AstraZeneca
ClinicalTrials ID:NCT05261399
This clinical trial is testing whether a combination of the drugs Savolitinib and Osimertinib is more effective and safer than standard chemotherapy for patients with advanced non-small cell lung cancer (NSCLC) that has worsened after treatment with Osimertinib.
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Program Overview
The purpose of this study is to compare the effectiveness and safety of a new drug combination, Savolitinib and Osimertinib, against the standard chemotherapy treatment for patients with advanced non-small cell lung cancer (NSCLC) that has specific genetic changes and has progressed after using Osimertinib. The study will involve about 324 participants who will be randomly assigned to receive either the new drug combination or standard chemotherapy. Participants will continue treatment until their cancer progresses, they experience unacceptable side effects, or they choose to stop.
Description
This study is a Phase III trial conducted at multiple centers to evaluate the effectiveness and safety of taking Savolitinib orally along with Osimertinib, compared to the usual chemotherapy treatment for patients with advanced non-small cell lung cancer (NSCLC) that has specific genetic mutations and has worsened after treatment with Osimertinib.
Approximately 324 participants will be randomly divided into two groups, with one group receiving the new drug combination and the other receiving standard chemotherapy. The treatment will continue until the cancer progresses, side effects become too severe, the participant withdraws consent, or other criteria for stopping are met.
Eligibility Criteria
Inclusion Criteria
- Must provide signed consent before any study procedures.
- Must be 18 years or older (19 in South Korea).
- Have a confirmed diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC) that cannot be cured.
- Have specific genetic changes in the cancer, such as EGFR mutations.
- Cancer must have worsened after treatment with Osimertinib.
- Must provide a tumor sample for testing.
- Cancer must show specific changes related to the MET gene after Osimertinib treatment.
- Must have measurable cancer according to specific criteria.
- Must have adequate blood, liver, kidney, and heart function.
- Must be in good general health with a performance status of 0 or 1.
Exclusion Criteria
- Have a type of lung cancer called squamous NSCLC or small cell lung cancer.
- Have been treated with other similar drugs besides Osimertinib.
- Have been treated with Savolitinib or other MET inhibitors.
- Have spinal cord compression or brain metastases unless they are stable and not causing symptoms.
- Have a history of cancer spreading to the brain or spinal fluid.
- Have unresolved side effects from previous treatments, except for hair loss and certain blood levels.
- Have serious heart conditions or abnormal heart rhythms.
- Have a history of serious liver disease or cirrhosis.
- Have active infections like tuberculosis, HIV, hepatitis B or C.
- Have received a live vaccine within 30 days before starting the study.
- Have a history of lung diseases like interstitial lung disease or radiation pneumonitis.
- Are taking medications or supplements that affect certain liver enzymes.
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