Skip to main content
OpenTrials
Completed

NCT Number: NCT01795352

Retrospective Study in a NSCLC M+ p

This is a national, multicentre, non-interventional, retrospective study to be carried out in the oncology settings of approximately 15-20 Spanish hospitals.

At each participant hospital, all patients recently diagnosed with advanced EGFR mutated NSCLC (both newly or with recurrent disease , without previous treatment for metastatic disease) from April 2010 to December 2011 will be included as study population. Information about the follow-up of the patients during a minimum of 12 months after diagnosis will be collected.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

EGFR Mutated Non-small Cell Lung Cancer Patients Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Barcelona, Spain

Loading trial locations.

About this study

Observational retrospective study to describe the management of advanced or metastatic EGFR mutated non-small cell lung cancer patients in Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically or cytologically confirmed newly locally advanced or metastatic NSCLC (stage IIIB/IV)
  • Confirmed EGFR mutation by a validated test
  • Availability of medical record

Exclusion criteria

  • Participating on a blinded randomized clinical trial at any time during the study period
  • Pregnant women (due to they do not reflect daily clinical practice)

Treatment and study plan

Primary outcomes

  1. Description of management patterns (clinical and diagnostic) of advanced/metastatic EGFR M+ NSCLC patients in Spain.

    Time frame: 32 months

Secondary outcomes

  1. Description of use of resources related with the management of advanced/metastatic EGFR M+ NSCLC patients in Spain.

    Time frame: 32 months

  2. Evaluation of overall response rate (ORR).

    Time frame: 32 months

  3. Evaluation of disease control rate (DCR).

    Time frame: 32 months

  4. Evaluation of progression free survival (PFS: median PFS and 1 year PFS rate).

    Time frame: 32 months

  5. Evaluation of overall survival (OS: median OS and 1 year OS rate).

    Time frame: 32 months

  6. Description of clinical outcome data in all EGFR M+ patients by regimen, type of EGFR TK mutation, line of therapy and other relevant demographics or clinic pathologic characteristics.

    Time frame: 32 months

    TK- Tyrosine Kinase

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Observational Retrospective Study to Describe the Management of Advanced or Metastatic EGFR (Epidermal Growth Factor Receptor) Mutated Non-small Cell Lung Cancer Patients in Spain

Acronym: Ca_Pulmon

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 20, 2013
Registry last updated
Oct 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.