Spots Global Cancer Trial Database for Osimertinib With or Without Savolitinib as 1L in de Novo MET+, EGFR+ NSCLC

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Trial Identification

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

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

Study ID: NCT05163249

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Osimertinib

Savolitinib

Study Description

Brief 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 Treatment will continue until either objective disease progression, unacceptable toxicity occurs, consent is withdrawn or another discontinuation criterion is met.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.