A Phase III, Randomised, Open-Label Study of Savolitinib in Combination With Osimertinib Versus Platinum-Based Doublet Chemotherapy in Participants With EGFR Mutated, MET-Overexpressed and/or Amplified, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed on Treatment With Osimertinib (SAFFRON).
Clinical study to investigate the efficacy and safety of savolitinib in combination with osimertinib versus platinum-based doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on treatment with Osimertinib.
• Provision of signed and dated written ICF prior to any mandatory and non-mandatory study-specific procedures, sampling and analyses.
• Participant must be ≥18 years (≥ 19 years of age in South Korea) at the time of signing the informed consent. All genders are permitted.
• Histologically or cytologically confirmed locally advanced or metastatic NSCLC which is not amenable to curative therapy.
• Must have at least one documented sensitising EGFR mutation: exon19 deletion, L858R mutation, and/or T790M.
• Documented radiologic progression on first- or second-line treatment with osimertinib as the most recent anti-cancer therapy.
• Mandatory provision of FFPE tumour tissue.
• MET overexpression and/or amplification in tumour specimen collected following progression on prior osimertinib treatment.
• Measurable disease as defined by RECIST 1.1.
• Adequate haematological, liver, renal and cardiac functions, and coagulation parameters.
• ECOG performance status of 0 or 1.