Treatment Patterns, Outcomes and Testing in EGFRm NSCLC Patients With EGFR TKI 1L Across Europe (REFLECT)

AstraZeneca

Status: Completed

Conditions: Lung Cancer

Treatments: Other: Non Interventional

Study type: Observational

Funder types: Industry

Identifiers

NCT04031898

D5162R00009

Details and patient eligibility

About

Multinational, multi-center medical record review to describe the treatment patterns, clinical outcomes, and EGFR / T790M testing practices in EGFR-mutated advanced NSCLC patients receiving first-line EGFR TKI therapy in Europe.

Full description

The aim is to generate real-life data on treatment patterns of the EGFR-mutated advanced NSCLC patients receiving first- or second-generation EGFR TKI in first line of therapy as provided per routine practice in eight countries. An approximate number of 820 patients will take part in the REFLECT study.

It is anticipated that data, generated from the proposed large cohort across centers in Europe, will facilitate a better understanding of unmet medical needs in first line of treatment and will provide a platform for improving patients' management.

Enrollment: 896 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of locally advanced unresectable or metastatic NSCLC;
• Aged at least 18 years at first diagnosis of locally advanced/metastatic NSCLC;
• Lab-confirmed EGFR mutation;
• Received a first- or second-generation EGFR TKI as first-line treatment for advanced/metastatic disease;
• First-line EGFR TKI (afatinib, gefitinib, erlotinib) initiated between January 1, 2015 and June 30, 2018;
• Patients may be alive or deceased at the time of medical record review.

Exclusion criteria

• Patients enrolled at any time in an interventional clinical trial for an experimental treatment related to EGFR-mutated NSCLC;

• Patients receiving any systemic therapy for locally advanced or metastatic NSCLC prior to first-line EGFR TKI treatment in the locally advanced/metastatic setting;

• Missing or unknown data on any of the following key study dates:

  • Date of initial NSCLC diagnosis;
  • Date of first diagnosis of or progression to advanced/metastatic NSCLC;
  • Date of first-line EGFR TKI initiation for advanced/metastatic disease;
  • Date of death or last available follow-up.

Trial design

896 participants in 1 patient group

full analysis set

Description:

All eligible patients who meet all inclusion criteria and none of the exclusion criteria

Treatment:

Other: Non Interventional