NCT04965701

First Line Osimertinib in the Real World: an Inter-regional Prospective Study

First Line Osimertinib in the Real World: an Inter-regional Prospective Study: FLOWER

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Istituto Oncologico Veneto IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study (FLOWER) will investigate effectiveness, safety, progression patterns and clinical management of untreated advanced NSCLC patients receiving fist-line osimertinib in the real-world.

Detailed description

FLOWER is a real-world, prospective, observational study enrolling patients with histological and/or cytological diagnosis of EGFR-mutant aNSCLC, receiving first-line treatment with the third-generation EGFR-TKI, osimertinib. All the patients received osimertinib at the recommended dose of 80 mg, orally, once a day. Dosing interruptions or reductions required, based on individual tolerability, were managed according to clinical practice in compliance with label indications. The FLOWER study aims at evaluating effectiveness, safety, progression pattern and clinical management of untreated EGFR-mutant aNSCLC patients in the real-world.

Conditions

• EGF-R Positive Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Osimertinib 80 MG	Osimertinib is administered according to clinical practice at the recommended dose of 80 mg, orally, once a day.

Timeline

• Start date: 2018-06-01
• Primary completion: 2022-06-01
• Completion: 2023-05-31
• First posted: 2021-07-16
• Last updated: 2023-11-13

Locations

1 site across 1 country: Italy