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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: August 15, 2012
Last updated: April 2, 2016
Last verified: April 2016
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-Squamous 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:

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 ]

Enrollment: 12
Study Start Date: January 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (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


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

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
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Please refer to this study by its identifier: NCT01667562

Belgrade, Serbia, 11000
Belgrade, Serbia, 11080
Knez Selo, Serbia, 18000
Sremska Kamenica, Serbia, 21204
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT01667562     History of Changes
Other Study ID Numbers: ML27860 
Study First Received: August 15, 2012
Last Updated: April 2, 2016
Health Authority: Serbia: Agency for Medicines and Medical Devices

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors processed this record on May 01, 2016