Study identifier:D5087C00001
ClinicalTrials.gov identifier:NCT05261399
EudraCT identifier:2021-006374-24
CTIS identifier:N/A
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).
Carcinoma
Phase 3
No
Savolitinib, Osimertinib, Pemetrexed, Cisplatin, Carboplatin
All
324
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Oct 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
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 | Drug: Pemetrexed Pemetrexed (500 mg/m2) Administrative route : IV infusion Other Name: NAP Drug: Cisplatin Cisplatin (75 mg/m2) or Administrative route : IV infusion Other Name: NAP Drug: Carboplatin Carboplatin (AUC5) Administrative route : IV infusion Other Name: NAP |
Experimental: Savolitinib + Osimertinib 300 mg savolitinib BID plus 80 mg osimertinib QD | Drug: Savolitinib 300 mg savolitinib (3 × 100 mg tablets twice daily) Administrative route : oral Other Name: AZD6094, HMPL-504, volitinib Drug: Osimertinib 80 mg osimertinib (1 × 80 mg tablet once daily) Administrative route : oral Other Name: AZD9291, Tagrisso |