NCT03761901

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
141

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2018

Shorter than P25 for all trials

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 21, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 3, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2019

Completed
Last Updated

May 8, 2020

Status Verified

May 1, 2020

Enrollment Period

9 months

First QC Date

November 16, 2018

Last Update Submit

May 7, 2020

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

EGFRmNSCLClocally advancedmetastaticlung cancer

Outcome Measures

Primary Outcomes (9)

  • demographic characteristics of patients diagnosed between 1 September 2015 and 31 December 2017

    28 months

  • NSCLC characteristics at diagnosis between 1 september 2015 and 31 December 2017

    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.

    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.

    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.

    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.

    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.

    36 months

  • EGFR testing characteristics at diagnosis between 1 september 2015 and 31 December 2017

    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.

    36 months

Secondary Outcomes (4)

  • PFS for 1L, 2L or 3L treatment during the observation window

    36 months

  • Time-to-treatment discontinuation for 1L, 2L and 3L treatment during the observation window

    36 months

  • Time to start of subsequent treatment after 1L and 2L treatment during the observation window

    36 months

  • OS during observation window

    36 months

Study Arms (1)

Patients with EGFR mutation positive NSCLC

Drug: 1L treatmentDrug: 2L TreatmentDrug: 3L treatment

Interventions

1L treatmentDRUG

chemotherapy, EGFR TKI, immunotherapy, other

Patients with EGFR mutation positive NSCLC
2L TreatmentDRUG

Chemotherapy, EGFR TKI, immunotherapy, other

Patients with EGFR mutation positive NSCLC
3L treatmentDRUG

chemotherapy, EGFR TKI, immunotherapy, other

Patients with EGFR mutation positive NSCLC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Research Site

Antwerp, 2020, Belgium

Location

Research Site

Bouge, 5004, Belgium

Location

Research Site

Brussels, 1090, Belgium

Location

Research Site

Brussels, 1200, Belgium

Location

Research Site

Charleroi, 6000, Belgium

Location

Research Site

Edegem, 2650, Belgium

Location

Research Site

Ghent, 9000, Belgium

Location

Research Site

Hasselt, 3500, Belgium

Location

Research Site

Mechelen, 2800, Belgium

Location

Research Site

Mons, 7000, Belgium

Location

Research Site

Roeselare, 8800, Belgium

Location

Research Site

Sint-Niklaas, 9100, Belgium

Location

Research Site

Sint-Truiden, 3800, Belgium

Location

Research Site

Turnhout, 2300, Belgium

Location

Research Site

Yvoir, 5530, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 33710523DERIVED

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungNeoplasm MetastasisLung Neoplasms

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2018

First Posted

December 3, 2018

Study Start

September 21, 2018

Primary Completion

June 19, 2019

Study Completion

June 19, 2019

Last Updated

May 8, 2020

Record last verified: 2020-05

Locations

BE(15)