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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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EGF-R Positive Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Osimertinib 80 MG


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Untreated EGFR-mutant advanced non-small-cell lung cancer patients<br> | Drug: Osimertinib 80 MG<br>* Osimertinib is administered according to clinical practice at the recommended dose of 80 mg, orally, once a day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |