Carcinoma, Non-Small-Cell LungREVEALNCT03761901
Study to Describe Treatment Patterns and Outcomes in EGFRm NSCLC Patients in Belgium
An observational study of Carcinoma, Non-Small-Cell Lung, run by AstraZeneca at 15 sites in Belgium.
Trial summary
This is a retrospective, observational, multicentre study to evaluate treatment patterns and outcomes of patients diagnosed with locally advanced or metastatic EGFRm NSCLC in Belgium Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- 1L treatment, 2L Treatment and 3L treatment
- How many people
- 141 participants
- Where
- 15 sitesBelgium
- Study dates
- 21 Sep 2018to 19 Jun 2019
- 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: Adult patients diagnosed with advanced or metastatic EGFRm NSCLC between 1 september 2015 and 31 December 2017
Who may be able to join
- Male or female, aged at least 18 years
- Pathologically confirmed NSCLC
- Tumour harbours a mutation of EGFR
- Diagnosis (radiologically or pathologically confirmed) of locally advanced or metastatic NSCLC, not amenable to curative surgery or chemoradiotherapy between 01 September 2015 and 31 December 2017
Who cannot join
- No follow-up data available after diagnosis of locally advanced or metastatic EGFRm NSCLC
- Patients who objected to participation to the study
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Belgium15 sites
Research Site
Antwerp, 2020
Research Site
Bouge, 5004
Research Site
Brussels, 1090
Research Site
Brussels, 1200
Research Site
Charleroi, 6000
Research Site
Edegem, 2650
Research Site
Ghent, 9000
Research Site
Hasselt, 3500
Research Site
Mechelen, 2800
Research Site
Mons, 7000
Research Site
Roeselare, 8800
Research Site
Sint-Niklaas, 9100
Research Site
Sint-Truiden, 3800
Research Site
Turnhout, 2300
Research Site
Yvoir, 5530
About this study
Official title: REtrospective, obserVational Study to Describe the Treatment Patterns and Outcomes of Epidermal Growth Factor Receptor Mutant (EGFRm) Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) Patients in Belgium
This is a retrospective, observational, multicentre study to evaluate treatment patterns and outcomes of patients diagnosed with locally advanced or metastatic EGFRm NSCLC in Belgium
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- 1L treatment, 2L Treatment, 3L treatment
- Keywords
- EGFRm, NSCLC, locally advanced, metastatic, lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1L treatmentDrug
chemotherapy, EGFR TKI, immunotherapy, other
2L TreatmentDrug
Chemotherapy, EGFR TKI, immunotherapy, other
3L treatmentDrug
chemotherapy, EGFR TKI, immunotherapy, other
| Study group | Role | What they receive |
|---|---|---|
| Patients with EGFR mutation positive NSCLC | Not described Receives: Drug: 1L treatment; Drug: 2L Treatment; Drug: 3L treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
demographic characteristics of patients diagnosed between 1 September 2015 and 31 December 2017
Measured: 28 months
NSCLC characteristics at diagnosis between 1 september 2015 and 31 December 2017
Measured: 28 months
NSCLC disease characteristics at start of 2L or 3L treatment during observation window
observation window: between date of diagnosis until the data cut-off , 01 September 2018, end of clinical activity or death, whichever comes first. Descriptive statitistics will be used to analyse these endpoints.
Measured: 36 months
Type of treatment received during 1L, 2L or 3L treatment during the observation window
observation window: between date of diagnosis until the data cut-off , 01 September 2018, end of clinical activity or death, whichever comes first. Descriptive statitistics will be used to analyse these endpoints.
Measured: 36 months
Time on treatment during 1L, 2L or 3L treatment during the observation window
observation window: between date of diagnosis until the data cut-off , 01 September 2018, end of clinical activity or death, whichever comes first. Descriptive statitistics will be used to analyse these endpoints.
Measured: 36 months
Proportion of patients receiving a definitive, systemic therapy for NSCLC or no definitive, systemic therapy for NSCLC/best supportive care treatment after progression on their previous therapy
observation window: between date of diagnosis until the data cut-off , 01 September 2018, end of clinical activity or death, whichever comes first. Descriptive statitistics will be used to analyse these endpoints.
Measured: 36 months
Reason for discontinuation after 1L, 2L or 3L treatment during observation window
observation window: between date of diagnosis until the data cut-off, 1 september 2018, end of clinical activity or death, whichever comes first. Descriptive statistics will be used to analyse these endpoints.
Measured: 36 months
EGFR testing characteristics at diagnosis between 1 september 2015 and 31 December 2017
Measured: 28 months
EGFR testing characteristics after progression on previous treatment
observation window: between date of diagnosis until the data cut-off, 01 September 2018 until end of clinical activity or death, whichever comes first. Descriptive statistics will be used to analyse these endpoints.
Measured: 36 months
Secondary outcomes (4)
PFS for 1L, 2L or 3L treatment during the observation window
observation window: between date of diagnosis until the data cut-off , 01 September 2018, end of clinical activity or death, whichever comes first. Kaplan-Meier analysis will be used.
Measured: 36 months
Time-to-treatment discontinuation for 1L, 2L and 3L treatment during the observation window
observation window: between date of diagnosis until the data cut-off , 01 September 2018, end of clinical activity or death, whichever comes first. Kaplan-Meier analysis will be used.
Measured: 36 months
Time to start of subsequent treatment after 1L and 2L treatment during the observation window
observation window: between date of diagnosis until the data cut-off , 01 September 2018, end of clinical activity or death, whichever comes first. Kaplan-Meier analysis will be used.
Measured: 36 months
OS during observation window
OS will be measured overall for all EGFRm NSCLC patients and depending on receipt of Osimertinib treatment and line of Osimertinib treatment.
observation window: between date of diagnosis until the data cut-off , 01 September 2018, end of clinical activity or death, whichever comes first.
Kaplan-Meier analysis will be used.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start21 Sep 2018
- Primary completion19 Jun 2019
- Study completion19 Jun 2019
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 Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03761901
- Sponsor's protocol ID
- D5161R00007
- Acronym
- REVEAL
- Status last verified
- May 2020
- First submitted
- 16 Nov 2018
- Last updated
- 8 May 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Cuppens K, Lodewyckx L, Demedts I, Decoster L, Colinet B, Deschepper K, Janssens A, Galdermans D, Pieters T; REVEAL Study Group. Real-World Treatment Patterns, Epidermal Growth Factor Receptor (EGFR) Testing and Outcomes in EGFR-Mutated Advanced Non-small Cell Lung Cancer Patients in Belgium: Results from the REVEAL Study. Drugs Real World Outcomes. 2021 Jun;8(2):141-152. doi: 10.1007/s40801-021-00243-w. Epub 2021 Mar 12.
PubMed 33710523
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REtrospective, obserVational Study to Describe the Treatment Patterns and Outcomes of Epidermal Growth Factor Receptor Mutant (EGFRm) Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) Patients in Belgium
- ClinicalTrials.gov ID
- NCT03761901
- Acronym / sponsor ID
- REVEAL / D5161R00007
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- EGFRm, NSCLC, locally advanced, metastatic, lung cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2018 (actual)
- Primary completion
- 19 Jun 2019 (actual)
- Study completion
- 19 Jun 2019 (actual)
- First posted
- 3 Dec 2018 (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 is a retrospective, observational, multicentre study to evaluate treatment patterns and outcomes of patients diagnosed with locally advanced or metastatic EGFRm NSCLC in Belgium
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with EGFR mutation positive NSCLC | – | Drug: 1L treatment, Drug: 2L Treatment, Drug: 3L treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with advanced or metastatic EGFRm NSCLC between 1 september 2015 and 31 December 2017
Key inclusion criteria (4 listed)
- Male or female, aged at least 18 years
- Pathologically confirmed NSCLC
- Tumour harbours a mutation of EGFR
- Diagnosis (radiologically or pathologically confirmed) of locally advanced or metastatic NSCLC, not amenable to curative surgery or chemoradiotherapy between 01 September 2015 and 31 December 2017
Key exclusion criteria (2 listed)
- No follow-up data available after diagnosis of locally advanced or metastatic EGFRm NSCLC
- Patients who objected to participation to the study
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 |
|---|---|---|
| 1L treatmentchemotherapy, EGFR TKI, immunotherapy, other | Drug | Patients with EGFR mutation positive NSCLC |
| 2L TreatmentChemotherapy, EGFR TKI, immunotherapy, other | Drug | Patients with EGFR mutation positive NSCLC |
| 3L treatmentchemotherapy, EGFR TKI, immunotherapy, other | Drug | Patients with EGFR mutation positive NSCLC |
Primary outcome
demographic characteristics of patients diagnosed between 1 September 2015 and 31 December 2017
Time frame: 28 months
NSCLC characteristics at diagnosis between 1 september 2015 and 31 December 2017
Time frame: 28 months
NSCLC disease characteristics at start of 2L or 3L treatment during observation window
Time frame: 36 months
observation window: between date of diagnosis until the data cut-off , 01 September 2018, end of clinical activity or death, whichever comes first. Descriptive statitistics will be used to analyse these endpoints.
Type of treatment received during 1L, 2L or 3L treatment during the observation window
Time frame: 36 months
observation window: between date of diagnosis until the data cut-off , 01 September 2018, end of clinical activity or death, whichever comes first. Descriptive statitistics will be used to analyse these endpoints.
Time on treatment during 1L, 2L or 3L treatment during the observation window
Time frame: 36 months
observation window: between date of diagnosis until the data cut-off , 01 September 2018, end of clinical activity or death, whichever comes first. Descriptive statitistics will be used to analyse these endpoints.
Proportion of patients receiving a definitive, systemic therapy for NSCLC or no definitive, systemic therapy for NSCLC/best supportive care treatment after progression on their previous therapy
Time frame: 36 months
observation window: between date of diagnosis until the data cut-off , 01 September 2018, end of clinical activity or death, whichever comes first. Descriptive statitistics will be used to analyse these endpoints.
Reason for discontinuation after 1L, 2L or 3L treatment during observation window
Time frame: 36 months
observation window: between date of diagnosis until the data cut-off, 1 september 2018, end of clinical activity or death, whichever comes first. Descriptive statistics will be used to analyse these endpoints.
EGFR testing characteristics at diagnosis between 1 september 2015 and 31 December 2017
Time frame: 28 months
EGFR testing characteristics after progression on previous treatment
Time frame: 36 months
observation window: between date of diagnosis until the data cut-off, 01 September 2018 until end of clinical activity or death, whichever comes first. Descriptive statistics will be used to analyse these endpoints.
4 secondary outcomes
PFS for 1L, 2L or 3L treatment during the observation window
Time frame: 36 months
Time-to-treatment discontinuation for 1L, 2L and 3L treatment during the observation window
Time frame: 36 months
Time to start of subsequent treatment after 1L and 2L treatment during the observation window
Time frame: 36 months
OS during observation window
Time frame: 36 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 8 May 2020.
- Derived from this study: PubMed 33710523Cuppens K, Lodewyckx L, Demedts I, Decoster L, Colinet B, Deschepper K, Janssens A, Galdermans D, Pieters T; REVEAL Study Group. Real-World Treatment Patterns, Epidermal Growth Factor Receptor (EGFR) Testing and Outcomes in EGFR-Mutated Advanced Non-small Cell Lung Cancer Patients in Belgium: Results from the REVEAL Study. Drugs Real World Outcomes. 2021 Jun;8(2):141-152. doi: 10.1007/s40801-021-00243-w. Epub 2021 Mar 12.
- Related InfoLink provided by the sponsor.
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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.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Non-Small-Cell Lung, run by AstraZeneca at 15 sites in Belgium.
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 4 inclusion and 2 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 8 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Belgium. 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?
demographic characteristics of patients diagnosed between 1 September 2015 and 31 December 2017 (time frame: 28 months). The study lists 9 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 NCT03761901, 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 8 May 2020.