Clinical trial NCT04965701: First Line Osimertinib in the Real World: an Inter-regional Prospective Study
Official title: First Line Osimertinib in the Real World: an Inter-regional Prospective Study: FLOWER
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: EGF-R Positive Non-Small Cell Lung Cancer
Lead sponsor: Istituto Oncologico Veneto IRCCS
Sponsor class: OTHER
First posted: 2021-07-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Median time to discontinuation (mTTD)
timeFrame: The primary analysis of mTTD will occur when all patients have had the opportunity to be treated for 6 months
measure: Rate of treatment related adverse events (AEs)
timeFrame: The primary analysis of safety will occur when all patients have had the opportunity to be treated for 6 months
measure: Rate of dose reduction and temporary or definitive treatment interruption due to AE
timeFrame: The primary analysis of safety will occur when all patients have had the opportunity to be treated for 6 months
Secondary outcomes:
measure: Median overall survival (mOS)
timeFrame: The primary analysis of mOS will occur when all patients have had the opportunity to be treated for 6 months
measure: Median progression free survival (mPFS)
timeFrame: The primary analysis of mPFS will occur when all patients have had the opportunity to be treated for 6 months
measure: Overall response rate
timeFrame: The primary analysis of ORR will occur when all patients have had the opportunity to be treated for 6 months
measure: Progression pattern
timeFrame: The primary analysis of progression patterns will occur when all patients have had the opportunity to be treated for 6 months
Other outcomes:
measure: Diagnostic-therapeutic pathway of patients included in the study
timeFrame: The primary analysis of diagnostic-therapeutic pathways will occur when all patients have had the opportunity to be treated for 6 months
Locations:
city: Padova
country: Italy
facility: Istituto Oncologico Veneto
Study officials:
References: