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

August, 2022

Scientific title

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).

Summary

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.

Study design

Primary purpose: Treatment, Allocation: Randomized, Intervention model: Parallel Assignment, Intervention model description: Parallel Assignment, Masking: None (Open Label),

Conditions

Carcinoma, Non-Small-Cell Lung

Other study ID numbers

D5087C00001; 2024-511169-12-00; 2021-006374-24

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