NCT05163249

Osimertinib With or Without Savolitinib as 1L in de Novo MET+, EGFR+ NSCLC

A Prospective, Pilot Study of First-line Osimertinib With or Without Savolitinib in de Novo MET Positive, EGFR-mutant NSCLCs (FLOWERS)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Guangdong Association of Clinical Trials · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, pilot, two-arm, randomized, multicenter study exploring the efficacy and safety of osimertinib with or without savolitinib as first-line therapy in patients with de novo MET positive, EGFR-mutant advanced NSCLC.

Detailed description

Approximately 44 eligible patients will be enrolled to randomly assigned to study interventions so that approximately 40 evaluable participants complete the study, based on an assumption of 10% of participants not completing the study. All eligible patients will be randomized in a 1:1 ratio to receive treatment with osimertinib (80 mg daily) or osimertinib (80 mg daily) in combination with savolitinib (300 mg BID) in this study. Treatment will continue until either objective disease progression, unacceptable toxicity occurs, consent is withdrawn or another discontinuation criterion is met. Patients who progress on first-line treatment of osimertinib monotherapy will have the opportunity to receive second-line treatment of osimertinib plus savolitinib after confirmation of MET status at disease progression.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	Osimertinib	osimertinib, 80mg, daily, P.O. Until objective disease progression, unacceptable toxicity occurs, consent is withdrawn or another discontinuation criteria is met
DRUG	Savolitinib	savolitinib 300mg BID, P.O. Until objective disease progression, unacceptable toxicity occurs, consent is withdrawn or another discontinuation criteria is met

Timeline

• Start date: 2022-05-31
• Primary completion: 2024-04-01
• Completion: 2026-08-01
• First posted: 2021-12-20
• Last updated: 2024-02-09

Locations

1 site across 1 country: China