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

NCT04965701 | Completed

• 1 other identifier: IOV-2020-FLOWER
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

EGF-R Positive Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Median overall survival (mOS)

  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)

  The primary analysis of mPFS will occur when all patients have had the opportunity to be treated for 6 months

• Overall response rate

  The primary analysis of ORR will occur when all patients have had the opportunity to be treated for 6 months

• Progression pattern

  The primary analysis of progression patterns will occur when all patients have had the opportunity to be treated for 6 months

Other Outcomes (1)

• 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

Study Arms (1)

Untreated EGFR-mutant advanced non-small-cell lung cancer patients

Drug: Osimertinib 80 MG

Interventions

Osimertinib 80 MG DRUG

Osimertinib is administered according to clinical practice at the recommended dose of 80 mg, orally, once a day.

Untreated EGFR-mutant advanced non-small-cell lung cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will include histologically confirmed advanced/metastatic NSCLC patients with sensitizing alteration of EGFR receiving osimertinib treatment in first-line setting.

You may qualify if:

• 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

You may not qualify if:

• Patients who receive study drugs in clinical trials will be excluded.

Sponsors & Collaborators

• Istituto Oncologico Veneto IRCCS: lead

Study Sites (1)

Istituto Oncologico Veneto

Padua, 35128, Italy

Location

MeSH Terms

Interventions

osimertinib

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 16, 2021
• Study Start: June 1, 2018
• Primary Completion: June 1, 2022
• Study Completion: May 31, 2023
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)