Evaluation in Real World of Molecular Testing and Treatment Patterns for EGFR Mutation in Lung Cancer Patients
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Observational

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
    

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.