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

EGF-R Positive Non-Small Cell Lung Cancer Clinical Trial

— FLOWER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04965701
• Other study ID #: IOV-2020-FLOWER
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: May 31, 2023

Study information

• Verified date: November 2023
• Source: Istituto Oncologico Veneto IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 31, 2023
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• EGF-R Positive Non-Small Cell Lung Cancer

Intervention

Drug:
• Osimertinib 80 MG
Osimertinib is administered according to clinical practice at the recommended dose of 80 mg, orally, once a day.

Locations

Country	Name	City	State
Italy	Istituto Oncologico Veneto	Padova

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Oncologico Veneto IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Diagnostic-therapeutic pathway of patients included in the study	To describe the diagnostic-therapeutic pathway of patients included in the study	The primary analysis of diagnostic-therapeutic pathways will occur when all patients have had the opportunity to be treated for 6 months
Primary	Median time to discontinuation (mTTD)	To evaluate the effectiveness of osimertinib in the real-world	The primary analysis of mTTD will occur when all patients have had the opportunity to be treated for 6 months
Primary	Rate of treatment related adverse events (AEs)	to evaluate safety of patients treated with osimertinib in the real-world	The primary analysis of safety will occur when all patients have had the opportunity to be treated for 6 months
Primary	Rate of dose reduction and temporary or definitive treatment interruption due to AE	to evaluate safety of patients treated with osimertinib in the real-world	The primary analysis of safety will occur when all patients have had the opportunity to be treated for 6 months
Secondary	Median overall survival (mOS)	To evaluate the effectiveness of osimertinib in the real-world	The primary analysis of mOS will occur when all patients have had the opportunity to be treated for 6 months
Secondary	Median progression free survival (mPFS)	To evaluate the effectiveness of osimertinib in the real-world	The primary analysis of mPFS will occur when all patients have had the opportunity to be treated for 6 months
Secondary	Overall response rate	To evaluate the effectiveness of osimertinib in the real-world	The primary analysis of ORR will occur when all patients have had the opportunity to be treated for 6 months
Secondary	Progression pattern	To evaluate the pattern of progression to first-line osimertinib in the real-world	The primary analysis of progression patterns will occur when all patients have had the opportunity to be treated for 6 months