EGF-R Positive Non-Small Cell Lung Cancer
Conditions
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.
Interventions
Osimertinib is administered according to clinical practice at the recommended dose of 80 mg, orally, once a day.
Sponsors
Istituto Oncologico Veneto IRCCS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | to evaluate safety of patients treated with osimertinib in the real-world |
| 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 | To evaluate the effectiveness of osimertinib in the real-world |
| 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 | to evaluate safety of patients treated with osimertinib in the real-world |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate | 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 |
| Progression pattern | 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 |
| Median overall survival (mOS) | 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 |
| Median progression free survival (mPFS) | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | To describe the diagnostic-therapeutic pathway of patients included in the study |
Countries
Italy
Outcome results
None listed