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

NCT04031898 | Completed

• 1 other identifier: D5162R00009
• Study Type: observational
• Target: 896
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer

Keywords

EGFR TKI; retrospective; treatment patterns; real world evidence

Outcome Measures

Primary Outcomes (3)

• First- or second-generation EGFR TKI used in first-line therapy

  Frequency distribution of first-line EGFR TKI of first- or second generation prescribed: erlotinib, gefitinib, or afatinib

  From date of initiating EGFR TKI in first line until the end of available follow-up or death, if this occurs before; assessed up to 60 months

• Proportion of patients progressing on first line EGFR TKI therapy and describe the time to progression

  Proportion of patients with a progression event during first-line EGFR TKI therapy or other evidence recorded in the patient's medical records deemed by the clinician to be indicative of progression; Time to progression, defined as time from EGFR TKI therapy initiation in the first-line locally advanced or metastatic setting until the earliest of progression death, or end of available follow-up (i.e., progression-free survival); Proportion of patients discontinuing first-line EGFR therapy for reasons other than progression event or death

  From date of initiating EGFR TKI in first line until the earliest of progression, death or end of available follow-up, whichever occur first; assessed up to 60 months

• Proportion of patients receiving second-line therapy and type of second-line therapy among patients progressing on first line EGFR TKI therapy

  Proportion of patients prescribed second-line therapy, as well as time to second-line therapy initiation, as defined by time from first-line EGFR TKI discontinuation until the earliest of second-line initiation, death, or end of available follow-up; Frequency distribution of the second-line therapy regimen (chemotherapy, osimertinib, other EGFR TKI, I/O therapy, or other therapy) among patients initiating second-line therapy.

  From date of initiating EGFR TKI in first line until date of starting second-line therapy; assessed up to 60 months

Secondary Outcomes (12)

• Patients' demographic and baseline disease characteristics

  From date of initial diagnosis of NSCLC or metastatic disease, whichever is diagnosed first until the end of available follow-up or death, if this occurs before; assessed up to 60 months

• Type of sample & test used to determine the EGFR mutation and type of EGFR mutation identified

  From date of metastatic disease diagnostic until the end of available follow-up or death, if this occurs before; assessed up to 60 months

• Proportion of patients with brain metastases (BM) among metastatic patients and the overall survival (OS) expectation in the group of patients with BM

  From date of metastatic disease diagnostic until the first BM diagnosis; From first BM diagnosis to the start of first-line EGFR TKI therapy, end of available follow-up or death, if this occurs before; all assessed up to 60 months

• Proportion of patients with leptomeningeal disease (LM) among metastatic patients and the overall survival (OS)

  From date of metastatic disease diagnostic until the LM diagnosis; From LM diagnosis to the start of first-line EGFR TKI therapy, end of available follow-up or death, if this occurs before; all assessed up to 60 months

• Proportion of patients where the first-line therapy with first- or second-generation EGFR TKI is associated with any other systemic therapy, including the type of systemic therapy

  From date of initiating EGFR TKI in first line until the earliest of progression, death or end of available follow-up, whichever occurs first; assessed up to 60 months

Study Arms (1)

full analysis set

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

Other: Non Interventional

Interventions

Non Interventional OTHER

This is a non interventional, observational, retrospective study including patients with EGFR-mutated advanced NSCLC, treated with 1st or 2nd generation EGFR TKI therapy in first line

full analysis set

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

EGFR-Mutated Advanced Non-Small- cell Lung Cancer Patients Receiving First-Line EGFR TKI Therapy

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Wien, 1140, Bulgaria

Location

Related Publications (2)

• Janzic U, Turnsek N, Dediu M, Donev IS, Lupu R, Teodorescu G, Ciuleanu TE, Pluzanski A. Real-World Testing Practices, Treatment Patterns and Clinical Outcomes in Patients from Central Eastern Europe with EGFR-Mutated Advanced Non-Small Cell Lung Cancer: A Retrospective Chart Review Study (REFLECT). Curr Oncol. 2022 Aug 17;29(8):5833-5845. doi: 10.3390/curroncol29080460.

  PMID: 36005198 DERIVED

• Lampaki S, Mountzios G, Georgoulias V, Rapti A, Xanthakis I, Baka S, Mavroudis D, Samantas E, Athanasiadis E, Zagouri F, Charpidou A, Somarakis A, Papista C, Nikolaou A, Anastasopoulou E, Paparepa Z, Syrigos KN. Real-world management patterns in EGFR-mutant advanced non-small-cell lung cancer before first-line adoption of osimertinib: the REFLECT study in Greece. Future Oncol. 2022 Sep;18(28):3151-3164. doi: 10.2217/fon-2022-0386. Epub 2022 Aug 5.

  PMID: 35929414 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Konstantinos Syrigos, Prof.

  Oncology Unit, Athens University School of Medicine,

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: July 24, 2019
• Study Start: May 7, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: December 23, 2020

Record last verified: 2020-12

Locations

BU (1)