Clinical trial NCT03721289: Evaluation in Real World of Molecular Testing and Treatment Patterns for EGFR Mutation in Lung Cancer Patients
Official title: Evaluation in Real World of Molecular Testing and Treatment Patterns for EGFR Mutations in Patients With Advanced or Metastatic NSCLC at Front-line and Progression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2018-10-26
Enrollment: 463
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort 1: all registered cases of stage IV NSCLC patients, treatment naïve, diagnosed in the participant institution during one year (from Jan 1st 2017 to Dec 31st 2017).

Cohort 2: all EGFR positive patients progressed to an EFGR-TKI in the same period of time (from Jan 1st 2017 to Dec 31st 2017) In the case one patient meets eligibility criteria for both cohorts, this patient will be included only in the EFGR-TKI progressed cohort.

Brief summary: Evaluate molecular testing and treatment patterns for EGFR mutation in two different cohorts of stage IV NSCLC, at diagnosis (treatment naïve) and at the moment of progression to EGFR-TKIs. This study is non-indication seeking (NIS), descriptive in nature and does not attempt to test any specific a priori hypotheses.

Detailed description: Objectives and Hypotheses : The objectives of this study are to evaluate molecular testing and treatment patterns for EGFR mutation in two different cohorts of stage IV NSCLC, at diagnosis (treatment naïve) and at the moment of progression to EGFR-TKIs. This study is non-indication seeking (NIS), descriptive in nature and does not attempt to test any specific a priori hypotheses. The following study objectives will be assessed:

Primary Objectives

* To estimate parameters associated with molecular testing patterns at diagnosis of advance disease and progression to EGFR TKIs
* To estimate parameters associated with treatment patterns at frontline and at progression to a EGFR TKI therpay

Secondary Objectives

* To estimate the rate of central nervous system (CNS) metastases at diagnosis and after disease progression in EGFR+ NSCLC patients
* To estimate parameters associated with biopsy related complications

Study Design This will be an observational retrospective study of patients with Stage IV NSCLC in two different cohorts from participating sites in Uruguay, Argentina, Costa Rica, Colombia, Chile, Peru, and Republica Dominicana. Cohort 1: newly diagnosed Stage IV NSCL who are treatment naive Cohort 2: stage IV NSCLC EGFRm progressed after first or second generation EGFR-TKI

Data of patients meeting the study inclusion/exclusion criteria will be collected from diagnosis of Satge IV (cohort 1) or diagnosis of progression after first or second generation EGFR-TKI (cohort 2) until the maximum follow up registered in the medical record.

Data will be collected and entered in the electronic case report form (eCRF). All data will be collected using patient medical records. The investigator will be responsible for ensuring that all the required data is collected and entered into the eCRF. The site will collect the data that will be uploaded according to the data entry procedures.

Study Population Cohort

1: all registered cases of stage IV NSCLC patients, treatment naïve, diagnosed in the participant institution during one year (from Jan 1st 2017 to Dec 31st 2017). Cohort 2: all EGFR positive patients progressed to an EFGR-TKI in the same period of time (from Jan 1st 2017 to Dec 31st 2017)

In the case one patient meets eligibility criteria for both cohorts, this patient will be included only in the EFGR-TKI progressed cohort.

Exposures There are no specific drug exposures or interventions being evaluated, as cohort eligibility is not exposure-based, but rather disease-based.

Study Measures

* Patient demographic and clinical characteristics
* Molecular testing rates at Stage IV and at progression to EGFR TKI
* Molecular testing EGFR mutation results (common/uncommon mutations at advanced diagnosis, and T790M at progression)
* Treatment patterns at frontline and progression to EGFR TKIs
* Biopsy-related complications
* Percentage of patinets presenting with CNS metastasis at diagnosis of stage IV and at progression to EGFR TKIsCNS

Sample:

All patients diagnosed with Stage IV NSCLC at diagnosis and at progression to an EGFR-TKI; from January 1st , 2017 to December 31st, 2017 in selected centers of Uruguay, Argentina, Chile, Colombia

Statistical Analysis No formal hypothesis testing is specified. Study measures including patient demographics and clinical characteristics, molecular testing rates and patterns, treatment patterns. Continuous study measures (e.g., age) will be reported descriptively with mean, standard deviation, median, minimum and maximum. Frequencies and percentages will be used to document categorical measures of interest (e.g., number and proportion of patients with a molecular test, number and proportion of patients with a EGFR mutation) and will include 95% CIs for key outcome variables.

Study Duration Estimated date of First Patient Data In: Q3 2018

Estimated date of Data Base Lock: Q1 2019

Eligibility criteria: Inclusion Criteria Cohort 1

* Adult male or female patients ≥ 18 years of age
* Newly diagnosed patients with stage IV NSCLC who are treatment naïve, from 1st Jan 2017 to Dec 31st 2017
* For patients still avile, provision of written informed consent as per local regulations

Cohort 2

* Adult male or female patients ≥ 18 years of age
* Patinets Stage IV NSCLC progressed after a first line TKI from 1st Jan 2017 to Dec 31st 2017.
* For patients still avile, provision of written informed consent as per local regulations

In the case one patient meets eligibility criteria for both cohorts, this patient will be included only in the EFGR-TKI progressed cohort.

Exclusion Criteria

• There are not exclusion criteria to this study. For an overview on the guidelines to determine disease progression, refer to Appendix A (Section 11).

Primary outcomes:
measure: Evaluation of the EGFR mutation
timeFrame: Clinical charts from January 2013-december 2017
Secondary outcomes:
Other outcomes:
Locations:
city: Caba
country: Argentina
facility: Research Site
city: Cordoba
country: Argentina
facility: Research Site
city: La Plata
country: Argentina
facility: Research Site
city: Rosario
country: Argentina
facility: Research Site
city: Santiago de Chile
country: Chile
facility: Research Site
city: Bogota
country: Colombia
facility: Research Site
city: Cali
country: Colombia
facility: Research Site
city: Medellín
country: Colombia
facility: Research Site
city: Monteria
country: Colombia
facility: Research Site
city: Montevideo
country: Uruguay
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Florencia Reinhold, MD
role: PRINCIPAL_INVESTIGATOR
References: