Clinical trial NCT04031898: Treatment Patterns, Outcomes and Testing in EGFRm NSCLC Patients With EGFR TKI 1L Across Europe (REFLECT)
Official title: Real World Treatment Patterns, Clinical Outcomes and EGFR / T790M Testing Practices in EGFR-Mutated Advanced Non-Small Cell Lung Cancer Patients Receiving First-Line TKI Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: EGFR TKI
retrospective
treatment patterns
real world evidence
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2019-07-24
Enrollment: 896
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: EGFR-Mutated Advanced Non-Small- cell Lung Cancer Patients Receiving First-Line EGFR TKI Therapy

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: First- or second-generation EGFR TKI used in first-line therapy
timeFrame: 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
measure: Proportion of patients progressing on first line EGFR TKI therapy and describe the time to progression
timeFrame: 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
measure: Proportion of patients receiving second-line therapy and type of second-line therapy among patients progressing on first line EGFR TKI therapy
timeFrame: From date of initiating EGFR TKI in first line until date of starting second-line therapy; assessed up to 60 months
Secondary outcomes:
measure: Patients' demographic and baseline disease characteristics
timeFrame: 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
measure: Type of sample & test used to determine the EGFR mutation and type of EGFR mutation identified
timeFrame: From date of metastatic disease diagnostic until the end of available follow-up or death, if this occurs before; assessed up to 60 months
measure: Proportion of patients with brain metastases (BM) among metastatic patients and the overall survival (OS) expectation in the group of patients with BM
timeFrame: 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
measure: Proportion of patients with leptomeningeal disease (LM) among metastatic patients and the overall survival (OS)
timeFrame: 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
measure: 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
timeFrame: 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
measure: Proportion of patients tested for T790M mutation and the proportion of patients with positive mutation among patients progressing on first-line EGFR TKI therapy
timeFrame: 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
measure: Proportion of patients receiving second-line therapy and type of second line therapy received among patients progressing on first-line EGFR TKI therapy and tested for T790M mutation
timeFrame: From date of initiating second-line therapy until the earliest of progression, death or end of available follow-up, whichever occurs first; assessed up to 55 months
measure: Proportion of patients receiving second-line therapy and type of second line therapy received among patients progressing on first-line EGFR TKI therapy and not tested for T790M
timeFrame: From date of initiating second-line therapy until the earliest of progression, death or end of available follow-up, whichever occurs first; assessed up to 55 months
measure: How the proportion of patients receiving second-line therapy differs between patients tested for T790M mutation and patients not tested for T790M mutations
timeFrame: From date of initiating second-line therapy until the earliest of progression, death or end of available follow-up, whichever occurs first; assessed up to 55 months
measure: Proportion of patients receiving third- or later-line therapy and type of this therapy and to explore whether the proportion receiving third-/later-line therapies varies by the second-line therapy category received
timeFrame: From date of initiating second-line therapy until the earliest of progression, death or end of available follow-up, whichever occurs first; assessed up to 50 months
measure: Overall survival (OS) expectation for all patients from first diagnosis of locally advanced or metastatic disease and from start of first-line EGFR TKI therapy
timeFrame: From date of metastatic disease diagnostic or start of first-line EGFR TKI therapy until the end of available follow-up or death, if this occurs before; assessed up to 60 months
measure: Incidence of other mutations, in case additional molecular testing was performed either at the time of initial EGFR testing or at the time of T790M testing
timeFrame: From date of metastatic disease diagnostic until end of available follow-up or death, if this occurs before; assessed up to 60 months
Other outcomes:
Locations:
city: Wien
country: Bulgaria
facility: Research Site
Study officials:
affiliation: Oncology Unit, Athens University School of Medicine,
name: Konstantinos Syrigos, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.