Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed on Osimertinib Treatment
- Trial number:
- NCT05261399
- Trial phase:
- 3
- Study type:
- Targeted therapy
- Overall status:
- Recruiting
Study start date
Scientific title
Summary
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.