Evaluation in Real World of Molecular Testing and Treatment Patterns for EGFR Mutation in Lung Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

463 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-29

Study Completion Date

2019-03-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Diagnosis and Treatment Strategies in Patients With NSCLC With or Without EGFR Mutations.

NCT01525199

Stage IIIB/IV Non-Small Cell Lung Cancer

COMPLETED

Non-interventional, Prospective Study to Determine Prevalence of EGFR Mutations in Non-small Cell Lung Cancer

NCT04742192

Non-small Cell Lung Cancer

COMPLETED

Frequency of EGFR Mutations in Latinos/Hispanics With Non-Small Cell Lung Cancer

NCT01255150

Non-Small-Cell Lung Carcinoma

COMPLETED

Epidemiological Study to Evaluate the Prevalence of Epidermal Growth Factor Receptor (EGFR) Mutation Status in Patients With Newly Diagnosed Locally Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)

NCT01081496

Non Small Cell Lung Cancer

COMPLETED

A Molecular Profiling Study of Patients With EGFR Mutation-positive Locally Advanced or Metastatic NSCLC Treated With Osimertinib

NCT03239340

EGFR Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Carcinoma, Non-Small-Cell Lung

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

No interventions assigned to this group

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)

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No