Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Untreated EGFR-mutant advanced non-small-cell lung cancer patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osimertinib 80 MG | Drug | Osimertinib is administered according to clinical practice at the recommended dose of 80 mg, orally, once a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Median time to discontinuation (mTTD) | To evaluate the effectiveness of osimertinib in the real-world | 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) | to evaluate safety of patients treated with osimertinib in the real-world | 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 | to evaluate safety of patients treated with osimertinib in the real-world | The primary analysis of safety will occur when all patients have had the opportunity to be treated for 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Median overall survival (mOS) | To evaluate the effectiveness of osimertinib in the real-world | The primary analysis of mOS will occur when all patients have had the opportunity to be treated for 6 months |
| Median progression free survival (mPFS) |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic-therapeutic pathway of patients included in the study | To describe the 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 |
Inclusion Criteria:
Exclusion Criteria:
Patients who receive study drugs in clinical trials will be excluded.
Not provided
Not provided
Not provided
The study will include histologically confirmed advanced/metastatic NSCLC patients with sensitizing alteration of EGFR receiving osimertinib treatment in first-line setting.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Oncologico Veneto | Padova | 35128 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38520745 | Derived | Pasello G, Lorenzi M, Scattolin D, Del Conte A, Cecere F, Pavan A, Macerelli M, Polo V, Pilotto S, Santarpia M, Cumerlato E, Da Ros V, Targato G, Bortolami A, Bonanno L, Ferro A, Dal Maso A, Frega S, Guarneri V. Osimertinib in Patients With Treatment-Naive EGFR-Mutant Non-small Cell Lung Cancer: Overall Survival, Post-progression Management and Budget Impact Analysis in Real-World. Oncologist. 2024 Jul 5;29(7):596-608. doi: 10.1093/oncolo/oyae043. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000596361 | osimertinib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the effectiveness of osimertinib in the real-world
| The primary analysis of mPFS will occur when all patients have had the opportunity to be treated for 6 months |
| Overall response rate | To evaluate the effectiveness of osimertinib in the real-world | The primary analysis of ORR will occur when all patients have had the opportunity to be treated for 6 months |
| Progression pattern | To evaluate the pattern of progression to first-line osimertinib in the real-world | The primary analysis of progression patterns will occur when all patients have had the opportunity to be treated for 6 months |