Study to Describe Treatment Patterns and Outcomes in EGFRm NSCLC Patients in Belgium (REVEAL)

May 7, 2020 updated by: AstraZeneca

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

141

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium, 2020
        • Research Site
      • Bouge, Belgium, 5004
        • Research Site
      • Brussels, Belgium, 1090
        • Research Site
      • Bruxelles, Belgium, 1200
        • Research Site
      • Charleroi, Belgium, 6000
        • Research Site
      • Edegem, Belgium, 2650
        • Research Site
      • Gent, Belgium, 9000
        • Research Site
      • Hasselt, Belgium, 3500
        • Research Site
      • Mechelen, Belgium, 2800
        • Research Site
      • Mons, Belgium, 7000
        • Research Site
      • Roeselare, Belgium, 8800
        • Research Site
      • Sint-Niklaas, Belgium, 9100
        • Research Site
      • Sint-Truiden, Belgium, 3800
        • Research Site
      • Turnhout, Belgium, 2300
        • Research Site
      • Yvoir, Belgium, 5530
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients diagnosed with advanced or metastatic EGFRm NSCLC between 1 september 2015 and 31 December 2017

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • No follow-up data available after diagnosis of locally advanced or metastatic EGFRm NSCLC
  • Patients who objected to participation to the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with EGFR mutation positive NSCLC
Drug: 1L treatment
chemotherapy, EGFR TKI, immunotherapy, other
Drug: 2L Treatment
Chemotherapy, EGFR TKI, immunotherapy, other
Drug: 3L treatment
chemotherapy, EGFR TKI, immunotherapy, other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
demographic characteristics of patients diagnosed between 1 September 2015 and 31 December 2017
Time Frame: 28 months
28 months
NSCLC characteristics at diagnosis between 1 september 2015 and 31 December 2017
Time Frame: 28 months
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.
36 months
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.
36 months
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.
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
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.
36 months
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.
36 months
EGFR testing characteristics at diagnosis between 1 september 2015 and 31 December 2017
Time Frame: 28 months
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.
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS for 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. Kaplan-Meier analysis will be used.
36 months
Time-to-treatment discontinuation for 1L, 2L and 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. Kaplan-Meier analysis will be used.
36 months
Time to start of subsequent treatment after 1L and 2L 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. Kaplan-Meier analysis will be used.
36 months
OS during observation window
Time Frame: 36 months

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.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 21, 2018

Primary Completion (ACTUAL)

June 19, 2019

Study Completion (ACTUAL)

June 19, 2019

Study Registration Dates

First Submitted

November 16, 2018

First Submitted That Met QC Criteria

November 30, 2018

First Posted (ACTUAL)

December 3, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 8, 2020

Last Update Submitted That Met QC Criteria

May 7, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5161R00007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Carcinoma, Non-Small-Cell Lung

Clinical Trials on 1L treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe