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.
Study Type
OBSERVATIONAL
Enrollment
200
Osimertinib is administered according to clinical practice at the recommended dose of 80 mg, orally, once a day.
Istituto Oncologico Veneto
Padua, Italy
Median time to discontinuation (mTTD)
To evaluate the effectiveness of osimertinib in the real-world
Time frame: 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
Time frame: 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
Time frame: The primary analysis of safety will occur when all patients have had the opportunity to be treated for 6 months
Median overall survival (mOS)
To evaluate the effectiveness of osimertinib in the real-world
Time frame: 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
Time frame: 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
Time frame: The primary analysis of ORR will occur when all patients have had the opportunity to be treated for 6 months
Progression pattern
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To evaluate the pattern of progression to first-line osimertinib in the real-world
Time frame: The primary analysis of progression patterns will occur when all patients have had the opportunity to be treated for 6 months