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

Completed

• Conditions: EGF-R Positive Non-Small Cell Lung Cancer
• Interventions: Drug: Osimertinib 80 MG

• Registration Number: NCT04965701
• Lead Sponsor: Istituto Oncologico Veneto IRCCS

Brief 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.

Study Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2021-07-07
• Study First Submitted QC: 2021-07-15
• Study First Posted: 2021-07-16
• Primary Completion: 2022-06-01
• Study Completion: 2023-05-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-09
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Untreated EGFR-mutant advanced non-small-cell lung cancer patients	Osimertinib 80 MG	-

Primary Outcome Measures

Name	Time	Method
Rate of treatment related adverse events (AEs)	The primary analysis of safety will occur when all patients have had the opportunity to be treated for 6 months	to evaluate safety of patients treated with osimertinib in the real-world
Median time to discontinuation (mTTD)	The primary analysis of mTTD will occur when all patients have had the opportunity to be treated for 6 months	To evaluate the effectiveness of osimertinib in the real-world
Rate of dose reduction and temporary or definitive treatment interruption due to AE	The primary analysis of safety will occur when all patients have had the opportunity to be treated for 6 months	to evaluate safety of patients treated with osimertinib in the real-world

Secondary Outcome Measures

Name	Time	Method
Median progression free survival (mPFS)	The primary analysis of mPFS will occur when all patients have had the opportunity to be treated for 6 months	To evaluate the effectiveness of osimertinib in the real-world
Median overall survival (mOS)	The primary analysis of mOS will occur when all patients have had the opportunity to be treated for 6 months	To evaluate the effectiveness of osimertinib in the real-world
Overall response rate	The primary analysis of ORR will occur when all patients have had the opportunity to be treated for 6 months	To evaluate the effectiveness of osimertinib in the real-world
Progression pattern	The primary analysis of progression patterns will occur when all patients have had the opportunity to be treated for 6 months	To evaluate the pattern of progression to first-line osimertinib in the real-world

Trial Locations

Locations (1)

Istituto Oncologico Veneto; 🇮🇹 Padova, Italy