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An Open-Label Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

This study is currently recruiting participants.
Verified June 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01667562
First received: August 15, 2012
Last updated: June 3, 2013
Last verified: June 2013
History of Changes
  Purpose

This open-label, multi-center study will evaluate the progression-free survival and safety of Tarceva (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the epidermal growth factor receptor (EGFR). Patients will receive daily oral doses of Tarceva until disease progression or unacceptable toxicity.


Condition Intervention Phase
Non-Small Cell Lung Cancer
 Drug: erlotinib [Tarceva]
 Phase 3

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: Phase IIIb, Open-label Study of Erlotinib (Tarceva®) Treatment in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Who Present Activating Mutations in the Tyrosine Kinase Domain of the Epidermal Growth Factor Receptor (ESSENCE)

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: Approximately 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]
  • Safety: incidence of adverse events [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]
  • Incidence of epidermal growth factor receptor mutations in patients [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tarceva Arm Drug: erlotinib [Tarceva]
Daily oral doses of 150 mg administered until disease progression or unacceptable toxicity

  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
  • Diagnosis of locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the epidermal growth factor receptor (EGFR)
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Life expectancy >/=12 weeks
  • Adequate hematological, liver and renal function

Exclusion Criteria:

  • Previous chemotherapy or treatment against EGFR for metastatic disease
  • Treatment with an investigational agent less than 3 weeks before enrolment
  • History of neoplasm other than non-small cell lung cancer (except carcinoma in situ of the uterine cervix, basal cell skin carcinoma, or prostate carcinoma)
  • Patients with symptomatic cerebral metastases
  • Any significant ophthalmologic abnormality
  • Unstable systemic disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01667562

Contacts
Contact: Reference Study ID Number: ML27860 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
Serbia
Recruiting
Belgrade, Serbia, 11080
Recruiting
Belgrade, Serbia, 11000
Recruiting
Knez Selo, Serbia, 18000
Recruiting
Sremska Kamenica, Serbia, 21204
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: NCT01667562     History of Changes
Other Study ID Numbers: ML27860
Study First Received: August 15, 2012
Last Updated: June 3, 2013
Health Authority: Serbia: Agency for Medicines and Medical Devices

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 17, 2013