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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01488331
Recruitment Status : Completed
First Posted : December 8, 2011
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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 or disease
Non-Squamous Non-Small Cell Lung Cancer

Study Type : Observational
Actual Enrollment : 217 participants
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
Study Start Date : June 2010
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

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


Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Best treatment response [ Time Frame: 24 months ]
  2. Overall survival [ Time Frame: 24 months ]
  3. Safety (incidence of adverse events) [ Time Frame: 24 months ]
  4. Type of treatment response [ Time Frame: 24 months ]
  5. Treatment compliance of patient [ Time Frame: 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients with non-small cell lung cancer

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01488331

  Show 92 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT01488331     History of Changes
Other Study ID Numbers: ML22973
First Posted: December 8, 2011    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

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