Clinical trial · Observational
First Line Osimertinib in the Real World: an Inter-regional Prospective Study
First Line Osimertinib in the Real World: an Inter-regional Prospective Study: FLOWER
NCT04965701CI-TRIAL-00071247FLOWERcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| EGF-R Positive Non-Small Cell Lung Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Osimertinib 80 MG | Drug | Osimertinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Untreated EGFR-mutant advanced non-small-cell lung cancer patients
- interventionNames
- Drug: Osimertinib 80 MG
Primary outcomes (3)
- measure
- Median time to discontinuation (mTTD)
- timeFrame
- The primary analysis of mTTD will occur when all patients have had the opportunity to be treated for 6 months
- description
- To evaluate the effectiveness of osimertinib in the real-world
- measure
- Rate of treatment related adverse events (AEs)
- timeFrame
- The primary analysis of safety will occur when all patients have had the opportunity to be treated for 6 months
- description
- to evaluate safety of patients treated with osimertinib in the real-world
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDPasello 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. PMID 38520745