drugset / Trial / NCT05261399

Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed on Osimertinib Treatment

NCT05261399 ↗

Phase 3 Active not recruiting 345 enrolled AstraZeneca
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2022-08-03
Primary completion
2026-06-18
Completion
2026-11-23

Outcome

Met primary endpoint

release “SAFFRON Phase III trial showed ORPATHYS® (savolitinib) plus TAGRISSO® (osimertinib) demonstrated a statistically significant and clinically meaningful improvement in both progression-free survival” hutch-med.com ↗

release “SAFFRON showed ORPATHYS® plus TAGRISSO® demonstrated a statistically significant and clinically meaningful improvement in both progression-free survival (“PFS”) and overall survival” hutch-med.com ↗

release “positive high-level results from the SAFFRON Phase III trial showed ORPATHYS® (savolitinib) plus TAGRISSO® (osimertinib) demonstrated a statistically significant and clinically meaningful improvement” hutch-med.com ↗

release “improvement in both progression-free survival (“PFS”) and overall survival (“OS”) versus doublet platinum-based chemotherapy” astrazeneca.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Carboplatin Small molecule 5 unknown Intravenous
Comparator Cisplatin Other / unclassified 75 mg/m2 Intravenous
Subject Osimertinib Small molecule 80 mg Oral
Comparator Pemetrexed Small molecule 500 mg/m2 Intravenous
Subject Savolitinib Small molecule 300 mg Oral