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Completed

NCT Number: NCT04965701

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

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.

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Key information

Conditions

EGF-R Positive Non-Small Cell Lung Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Oncologico Veneto

Padova, 35128, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Osimertinib 80 MG

Drug

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

Primary outcomes

  1. Median time to discontinuation (mTTD)

    Time frame: 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

  2. Rate of treatment related adverse events (AEs)

    Time frame: 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

  3. Rate of dose reduction and temporary or definitive treatment interruption due to AE

    Time frame: 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 outcomes

  1. Median overall survival (mOS)

    Time frame: 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

  2. Median progression free survival (mPFS)

    Time frame: 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

  3. Overall response rate

    Time frame: 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

  4. Progression pattern

    Time frame: 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

Other outcomes

  1. Diagnostic-therapeutic pathway of patients included in the study

    Time frame: The primary analysis of diagnostic-therapeutic pathways will occur when all patients have had the opportunity to be treated for 6 months

    To describe the diagnostic-therapeutic pathway of patients included in the study

Sponsors and collaborators

Lead sponsor

Istituto Oncologico Veneto IRCCS

Other

Registry information

Official study title

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

Acronym: FLOWER

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Jul 16, 2021
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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