Are you or a loved one interested in participating in a Non-Small Cell Lung Cancer clinical trial?
This is a clinical trial for adults who have been diagnosed with MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on first- or second-line treatment with osimertinib as the most recent therapy.
The purpose of this study is to determine the direct effect of savolitinib in combination with osimertinib in comparison to platinum-based doublet chemotherapy as it is not confounded by the efficacy of subsequent therapies used after disease progression.
There are 3 study periods: screening, treatment, and follow-up. All aspects of your participation will take place at the study location or at your place of residence.
You will have health checks and tests to confirm that you are eligible for the study.
You will be given an Informed Consent Form that contains all of the information about the study. This is to make sure that you understand the study and ask any questions you may have. If you agree to participate, you will give your permission by signing this form.
The screening period is up to 28-days before the first dose of the study drug.
During the treatment period, eligible patients will receive the combination of Osimertinib and Savolitinib in 21-day cycles. The study medication will be taken daily by mouth. The treatment period will continue until unacceptable adverse events, documented disease progression, withdrawal of consent, loss to follow-up, death, or termination of the study (whichever occurs first).
Participants will complete an end of treatment visit within 7 days of the final dose
Participants will complete a 28-day safety follow-up
Participants will complete a progression follow-up
Participants will complete a survival follow-up
What treatment will I receive?
You will receive both daily by mouth.
Osimertinib and Savolitinib will be administered daily by mouth
You will continue your Standard of Care Chemotherapy IV infusion on Day 1 of each 21-day cycle for 4 cycles, followed by pemetrexed maintenance therapy Q3W