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Completed

NCT Number: NCT03761901

Study to Describe Treatment Patterns and Outcomes in EGFRm 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

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Antwerp, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1L treatment

Drug

chemotherapy, EGFR TKI, immunotherapy, other

2L Treatment

Drug

Chemotherapy, EGFR TKI, immunotherapy, other

3L treatment

Drug

chemotherapy, EGFR TKI, immunotherapy, other

Primary outcomes

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

    Time frame: 28 months

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

    Time frame: 28 months

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

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

    Time frame: 28 months

  9. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: REVEAL

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 3, 2018
Registry last updated
May 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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