Brief Summary
Clinical study to investigate the efficacy and safety of savolitinib in combination with osimertinib versus platinum-based doublet chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells in participants with EGFR mutated, MET-overexpressed and/or amplified, locally advancedat a late stage, far along or metastatic NSCLC who have progressed on treatment with Osimertinib.
Intervention / Treatment
- Drug: Savolitinib
- Drug: Osimertinib
- Drug: Pemetrexed
- Drug: Cisplatin
- Drug: Carboplatin
Inclusion Criteria:
- 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 consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment.. 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 tumoura tissue mass that forms from groups of unhealthy cells tissuea group of cells that work together to perform a function.
- MET overexpression and/or amplification in tumour specimena sample for investigating (e.g. blood, stools, urine, sputum etc.) 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.