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An Expanded Access Program of Tarceva (Erlotinib) in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00949910
First received: April 15, 2009
Last updated: December 5, 2011
Last verified: December 2011
History of Changes
  Purpose

This study will provide treatment with Tarceva to patients with advanced NSCLC who have received >=1 course of standard chemotherapy or radiation therapy, or who are not medically suitable for either. Efficacy and safety will be monitored throughout the study. The anticipated time on study treatment is as long as the patient is, in the investigator's opinion, benefiting from the therapy and the target sample size is 500+ individuals.


Condition Intervention Phase
Non-Small Cell Lung Cancer
 Drug: erlotinib [Tarceva]
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Expanded-access Study of the Effect of Tarceva on Treatment Response in Patients With Advanced Stage IIIB/IV Non-small-cell Lung Cancer

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:
  • Safety:Adverse events, serious adverse events, premature withdrawals\n\n [ Time Frame: At each clinic visit, throughout study.Length of study not specified ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy: Response rate, time to progression, survival [ Time Frame: At each clinic visit, throughout study. length of study not specified ] [ Designated as safety issue: No ]

Enrollment: 7040
Study Start Date: November 2004
Study Completion Date: August 2011
Arms Assigned Interventions
Experimental: 1 Drug: erlotinib [Tarceva]
1
Other Name: Tarceva

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients >=18 years of age;
  • histologically or cytologically documented inoperable, locally advanced, metastatic, or recurrent NSCLC;
  • previous treatment with <=2 prior chemotherapy regimens.

Exclusion Criteria:

  • previous systemic anti-cancer therapy with HER1/EGFR inhibitors;
  • inability to take oral medication;
  • any other malignancies within 5 years.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00949910

  Show 544 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Chair: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00949910     History of Changes
Other Study ID Numbers: MO18109
Study First Received: April 15, 2009
Last Updated: December 5, 2011
Health Authority: Netherlands:Medicines Evaluation Board

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 May 22, 2013