An Observational Study of Tarceva (Erlotinib) in Elderly Patients With Advanced Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01535729
First received: February 15, 2012
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This prospective observational study will evaluate the efficacy and safety of Ta rceva (erlotinib) in elderly patients with advanced non-small cell lung cancer ( NSCLC) after failure of at least one prior chemotherapy regimen. Data of patient s treated with Tarceva in routine clinical practice will be collected for 1 year


Condition
Non-Small Cell Lung Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Erlotinib (Tarceva®) in Routine Clinical Practice in Patients With Advanced Non Small Cell Lung Cancer (NSCLC) After Failure of at Least One Prior Chemotherapy Regimen With Focus on the Elderly Patient.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall survival according to different age groups [ Time Frame: at 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumor response [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 406
Study Start Date: May 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Elderly patients with advanced non-small cell lung cancer after first-line platinum-based chemotherapy

Criteria

Inclusion Criteria:

  • Adult patients, > 65 years of age
  • Locally advanced or metastatic non-small cell lung cancer (Stage IIIb or IV)
  • Failure of at least one prior standard platinum-based chemotherapy

Exclusion Criteria:

  • Age < 65 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01535729

Locations
Germany
Nürnberg, Germany, 90419
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01535729     History of Changes
Other Study ID Numbers: ML23023
Study First Received: February 15, 2012
Last Updated: August 4, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014