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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:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01066884
First received: February 4, 2010
Last updated: September 12, 2011
Last verified: September 2011
  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-Small Cell Lung Cancer
Drug: erlotinib [Tarceva]
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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) ] [ Designated as safety issue: No ]

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) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: April 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: erlotinib [Tarceva]
150mg po daily

  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;
  • 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
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: 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

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01066884     History of Changes
Other Study ID Numbers: ML20569
Study First Received: February 4, 2010
Last Updated: September 12, 2011
Health Authority: Russia: Ministry of Health

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

ClinicalTrials.gov processed this record on November 20, 2014