A Phase III, Randomised, Open-Label Study of Savolitinib inCombination With Osimertinib Versus Platinum-Based DoubletChemotherapy in Participants With EGFR MutatedMET-Overexpressed and/or Amplified, Locally Advanced orMetastatic Non-Small Cell Lung Cancer
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The purpose of this study is to learn more about an investigational drug called savolitinib in combination with osimertinib for the treatment of non-small cell lung cancer (NSCLC) compared to platinum-based doublet chemotherapy (a standard of care treatment). Participants will be randomly assigned to one of two study groups at the beginning of this study. This means participants will be assigned to a study group by chance, like flipping a coin or rolling dice. Investigational means that the drug is not approved by any health authority, except for use in research studies like this. People who have this usually have standard chemotherapy treatment. Chemotherapy works by targeting cancer cells that grow, multiply and divide quickly. Osimertinib is approved by health authorities for the treatment of NSCLC when the patient has a particular mutation in EGFR in their cancer. Osimertinib is known to work well initially when they have this particular mutation in their cancer, but resistance often occurs after several months of treatment. Osimertinib targets mutated forms of epidermal growth factor receptor (EGFR). Savolitinib works by targeting a protein called mesenchymal epithelial transition (MET),a protein that is involved in sending signals within cells and in cell growth and survival. Both osimertinib and savolitinib work to block the action of abnormal proteins that signal cancer cells to multiply.
Are you Eligible? (Inclusion Criteria)
- You are at least 18 years old. - You have histologically or cytologically confirmed locally advanced or metastatic NSCLC which is not amenable to curative therapy. - Documented radiologic progression on first- or second-line treatment with osimertinib as the most recent anti-cancer therapy. - You are able to swallow and retain oral medications. - You are willing and able to comply with study and follow-up procedures.
