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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: EGF-R Positive Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: Osimertinib 80 MG

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Italy
  • Padova, Italy, 35128
    • Istituto Oncologico Veneto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study will include histologically confirmed advanced/metastatic NSCLC patients with sensitizing alteration of EGFR receiving osimertinib treatment in first-line setting.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Untreated EGFR-mutant advanced non-small-cell lung cancer patients	Drug: Osimertinib 80 MG; Osimertinib is administered according to clinical practice at the recommended dose of 80 mg, orally, once a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Istituto Oncologico Veneto IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): June 1, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: July 7, 2021
• First Submitted That Met QC Criteria: July 15, 2021
• First Posted (Actual): July 16, 2021

Study Record Updates

• Last Update Posted (Actual): September 9, 2022
• Last Update Submitted That Met QC Criteria: September 8, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Osimertinib
• Other Study ID Numbers: IOV-2020-FLOWER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO