First Line Osimertinib in the Real World: an Inter-regional Prospective Study
- Sponsor
- Istituto Oncologico Veneto IRCCS
- Study ID
- NCT04965701
- Status
- Completed
Conditions
- EGF-R Positive Non-Small Cell Lung Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Osimertinib 80 MG — DRUGOsimertinib is administered according to clinical practice at the recommended dose of 80 mg, orally, once a day.
Study Details
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.
Key Dates
- First listed
- Jul 16, 2021
- Start date
- Jun 1, 2018
- Status verified
- Nov 2023
- Primary completion
- Jun 1, 2022
- Completion
- May 31, 2023
Study Design
- Enrollment
- 200 participants (actual)
Arms
- Arm: Untreated EGFR-mutant advanced non-small-cell lung cancer patients
Primary Outcome Measure
Median time to discontinuation (mTTD) [ Time Frame: The primary analysis of mTTD will occur when all patients have had the opportunity to be treated for 6 months ]