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

Istituto Oncologico Veneto IRCCS

Status: Completed

Conditions: EGF-R Positive Non-Small Cell Lung Cancer

Treatments: Drug: Osimertinib 80 MG

Study type: Observational

Funder types: Other

Identifiers

NCT04965701

IOV-2020-FLOWER

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• histological confirmed diagnosis of NSCLC and EGFR mutation in exon 18-21;
• locally advanced inoperable or metastatic disease (stage III and IV according to 8th edition of the TNM classification for lung cancer);
• first line treatment with the third generation EGFR TKI, osimertinib;
• age >18 years
• written informed consent

Exclusion criteria

Patients who receive study drugs in clinical trials will be excluded.

Trial design

200 participants in 1 patient group

Untreated EGFR-mutant advanced non-small-cell lung cancer patients

Treatment:

Drug: Osimertinib 80 MG