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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).

Who is this study for? Patients with Lung Carcinoma
Status: Active_not_recruiting
Location: See all (225) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 130
Healthy Volunteers: f
View:

• 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.

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Time Frame
Start Date: 2022-08-03
Completion Date: 2026-11-23
Participants
Target number of participants: 345
Treatments
Active_comparator: Chemotherapy
Pemetrexed (500 mg/m2) with either cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of 21-day cycles (Q3W) for 4 cycles, followed by pemetrexed maintenance (500 mg/m2) Q3W
Experimental: Savolitinib + Osimertinib
300 mg savolitinib BID plus 80 mg osimertinib QD
Sponsors
Leads: AstraZeneca

This content was sourced from clinicaltrials.gov