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A Study of First or Second Line Treatment With Tarceva (Erlotinib) in Patients With Advanced Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01066884
First Posted: February 10, 2010
Last Update Posted: August 24, 2016
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.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
This single arm study will assess the safety and efficacy of Tarceva monotherapy in patients with advanced non-small cell lung cancer. Patients will receive Tarceva 150mg p.o. daily. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Incidence of adverse events (AEs) [ Time Frame: Length of patient on study (length of time of patient on study determined by investigator) ]

Secondary Outcome Measures:
  • Best Response Rate per investigator assessment [ Time Frame: Length of patient on study (length of time of patient on study determined by investigator) ]
  • Time to Progression (TTP) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first ]
  • Overall survival [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first ]

Enrollment: 5
Study Start Date: April 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: erlotinib [Tarceva]
150mg po daily

  Eligibility

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
Criteria

Inclusion Criteria:

  • adult patients >= 18 years of age;
  • inoperable, locally advanced, recurrent or metastatic (Stage IIIB/IV) non-small cell lung cancer;
  • ECOG performance status of 0-3;
  • previously untreated, or failed on one prior course of standard systemic chemotherapy and/or radiotherapy.

Exclusion Criteria:

  • prior systemic anti-tumor therapy with HER1/EGFR inhibitors;
  • unstable systemic disease;
  • any other malignancies within 5 years (except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer;
  • any significant ophthalmologic abnormality.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01066884


Locations
Russian Federation
Balashikha, Russian Federation, 143900
Krasnoyarsk, Russian Federation, 660133
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01066884     History of Changes
Other Study ID Numbers: ML20569
First Submitted: February 4, 2010
First Posted: February 10, 2010
Last Update Posted: August 24, 2016
Last Verified: August 2016

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