EGF-R Positive Non-Small Cell Lung CancerFLOWERNCT04965701
First Line Osimertinib in the Real World: an Inter-regional Prospective Study
An observational study of EGF-R Positive Non-Small Cell Lung Cancer, run by Istituto Oncologico Veneto IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- EGF-R Positive Non-Small Cell Lung Cancer
- What is being tested?
- Osimertinib 80 MG
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2018to 31 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include histologically confirmed advanced/metastatic NSCLC patients with sensitizing alteration of EGFR receiving osimertinib treatment in first-line setting.
Who may be able to join
- 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
Who cannot join
- Patients who receive study drugs in clinical trials will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: First Line Osimertinib in the Real World: an Inter-regional Prospective Study: FLOWER
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.
Read the detailed description
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.
- Being tested
- Osimertinib 80 MG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osimertinib 80 MGDrug
Osimertinib is administered according to clinical practice at the recommended dose of 80 mg, orally, once a day.
| Study group | Role | What they receive |
|---|---|---|
| Untreated EGFR-mutant advanced non-small-cell lung cancer patients | Not described Receives: Drug: Osimertinib 80 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median time to discontinuation (mTTD)
To evaluate the effectiveness of osimertinib in the real-world
Measured: 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
Measured: 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
Measured: 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)
To evaluate the effectiveness of osimertinib in the real-world
Measured: 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
Measured: 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
Measured: 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
Measured: The primary analysis of progression patterns will occur when all patients have had the opportunity to be treated for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start1 Jun 2018
- Primary completion1 Jun 2022
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EGF-R Positive Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Oncologico Veneto IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04965701
- Sponsor's protocol ID
- IOV-2020-FLOWER
- Acronym
- FLOWER
- Status last verified
- Nov 2023
- First submitted
- 7 Jul 2021
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Pasello 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.
PubMed 38520745
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Line Osimertinib in the Real World: an Inter-regional Prospective Study: FLOWER
- ClinicalTrials.gov ID
- NCT04965701
- Acronym / sponsor ID
- FLOWER / IOV-2020-FLOWER
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Istituto Oncologico Veneto IRCCSUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 16 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Untreated EGFR-mutant advanced non-small-cell lung cancer patients | – | Drug: Osimertinib 80 MG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include histologically confirmed advanced/metastatic NSCLC patients with sensitizing alteration of EGFR receiving osimertinib treatment in first-line setting.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who receive study drugs in clinical trials will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osimertinib 80 MGOsimertinib is administered according to clinical practice at the recommended dose of 80 mg, orally, once a day. | Drug | Untreated EGFR-mutant advanced non-small-cell lung cancer patients |
Primary outcome
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
To evaluate the effectiveness of osimertinib in the real-world
Rate of treatment related adverse events (AEs)
Time frame: The primary analysis of safety will occur when all patients have had the opportunity to be treated for 6 months
to evaluate safety of patients treated with osimertinib in the real-world
Rate of dose reduction and temporary or definitive treatment interruption due to AE
Time frame: The primary analysis of safety will occur when all patients have had the opportunity to be treated for 6 months
to evaluate safety of patients treated with osimertinib in the real-world
4 secondary outcomes
Median overall survival (mOS)
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)
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
Time frame: The primary analysis of ORR will occur when all patients have had the opportunity to be treated for 6 months
Progression pattern
Time frame: The primary analysis of progression patterns will occur when all patients have had the opportunity to be treated for 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Derived from this study: PubMed 38520745Pasello 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of EGF-R Positive Non-Small Cell Lung Cancer, run by Istituto Oncologico Veneto IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04965701, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.