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First Line Osimertinib in the Real World: an Inter-regional Prospective Study | Clinical Trials | Clareo Health

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

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

NCT04965701•Istituto Oncologico Veneto IRCCS

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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.

Locations (1)

Istituto Oncologico Veneto

Padua, Italy

Key Dates

Start Date

June 1, 2018

Primary Completion Date

June 1, 2022

Completion Date

May 31, 2023

Last Updated

November 13, 2023

Enrollment

200

ACTUAL participants

Conditions

EGF-R Positive Non-Small Cell Lung Cancer

Interventions

Osimertinib 80 MG

DRUG

The Efficacy and Safety of LMV-12 Combined With Osimertinib in NSCLC

NCT06109558

Non Small Cell Lung CancerRET Gene Mutation+2 more

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ACTIVE_NOT_RECRUITINGPHASE2

Dacomitinib in Lung Cancer With Uncommon EGFR Mutations

NCT04504071

Non-small Cell Lung Cancer MetastaticEGF-R Positive Non-Small Cell Lung Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 13, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

The Efficacy and Safety of LMV-12 Combined With Osimertinib in NSCLC

Dacomitinib in Lung Cancer With Uncommon EGFR Mutations

(HARMONY) Study of BLU-701 in EGFR-mutant NSCLC

Pembrolizumab, Lenvatinib and Chemotherapy After TKIs in NSCLC

Icotinib as Neoadjuvant and Adjuvant Therapy in EGFR-mutant Stage IIIB or Oligometastasis Non-small Cell Lung Cancer