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An Observational Study of Tarceva (Erlotinib) in Patients With 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:
NCT01488331
First received: December 6, 2011
Last updated: June 3, 2013
Last verified: June 2013
History of Changes
  Purpose

This prospective, multi-center, observational study will assess the progression-free survival and safety of patients with locally advanced or metastatic non-small cell lung cancer treated with Tarceva (erlotinib) and not disease progressing after at least 9 months. Data will be collected for 24 months.


Condition
Non-Small Cell Lung Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Patient Cohort With Locally Advanced or Metastatic Non-small Cell Lung Cancer Treated With Tarceva (Erlotinib) Monotherapy and Not Progressing After at Least 9 Months

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Best treatment response [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Safety (incidence of adverse events) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Type of treatment response [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Treatment compliance of patient [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 216
Study Start Date: June 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Adult patients with non-small cell lung cancer

Criteria

Inclusion Criteria:

  • Adult patients, >/=18 years of age
  • Diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC, stage III/IV)
  • Treatment with Tarceva monotherapy and not progressing after at least 9 months at the date of study start

Exclusion Criteria:

  • Not agreeing to be followed-up (for a maximum of 24 months)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01488331

  Show 92 Study Locations
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: NCT01488331     History of Changes
Other Study ID Numbers: ML22973
Study First Received: December 6, 2011
Last Updated: June 3, 2013
Health Authority: France: Commission Nationale de l'Informatique et des Libertés (CNIL)

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 June 18, 2013