Clinical trial
First Line Osimertinib in the Real World: an Inter-regional Prospective Study: FLOWER
Name
IOV-2020-FLOWER
Description
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.
Trial arms
Trial start
2018-06-01
Estimated PCD
2022-06-01
Trial end
2023-05-31
Status
Completed
Treatment
Osimertinib 80 MG
Osimertinib is administered according to clinical practice at the recommended dose of 80 mg, orally, once a day.
Arms:
Untreated EGFR-mutant advanced non-small-cell lung cancer patients
Size
200
Primary endpoint
Median time to discontinuation (mTTD)
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)
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
The primary analysis of safety will occur when all patients have had the opportunity to be treated for 6 months
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 200, 'type': 'ACTUAL'}}
Updated at
2023-11-13
1 organization
1 product
1 indication
Organization
Istituto Oncologico Veneto IRCCSProduct
OsimertinibIndication
EGFR Positive Non-Small Cell Lung Cancer