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A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (ESSENCE)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01667562
First Posted: August 17, 2012
Last Update Posted: August 29, 2017
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 open-label, multi-center study will evaluate the progression-free survival and safety of erlotinib in participants 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). Participants will receive daily oral doses of erlotinib until disease progression or unacceptable toxicity.

Condition Intervention Phase
Non-Small Cell Lung Cancer Drug: Erlotinib Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-Free Survival as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v 1.1) [ Time Frame: Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months) ]

Secondary Outcome Measures:
  • Percentage of Participants with Objective Response as Assessed by RECIST v 1.1 [ Time Frame: Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months) ]
  • Percentage of Participants with Disease Control as Assessed by RECIST v 1.1 [ Time Frame: Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months) ]
  • Percentage of Participants With EGFR Mutations [ Time Frame: Screening up to approximately up to 4 years and 9 months ]
  • Percentage of Participants with Adverse Events or Serious Adverse Events [ Time Frame: Baseline up to approximately 4 years and 9 months ]
  • Change From Baseline in Quality of Life Score Using The Functional Assessment of Cancer Therapy Lung (FACT-L) at every 6 Week [ Time Frame: Baseline, at every 6 week until disease progression, death or unacceptable toxicity, or end of treatment (whichever occurs first) (approximately 4 years and 9 months) ]

Enrollment: 30
Actual Study Start Date: January 20, 2012
Estimated Study Completion Date: February 26, 2025
Estimated Primary Completion Date: February 26, 2025 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Erlotinib
Erlotinib will be administered as a single daily oral dose of 150 milligrams until disease progression, death or unacceptable toxicity.
Drug: Erlotinib
Daily oral doses administered until disease progression or unacceptable toxicity or death.
Other Name: Tarceva

  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:

  • Diagnosis of locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the EGFR
  • Measurable disease according to RECIST
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Life expectancy greater than or equal to (>/=) 12 weeks
  • Adequate hematological, liver and renal function
  • Participants with asymptomatic and stable cerebral metastases receiving medical treatment

Exclusion Criteria:

  • Previous chemotherapy or treatment against EGFR for metastatic disease
  • Treatment with an investigational agent less than 3 weeks before enrollment
  • 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)
  • Participants with symptomatic cerebral metastases
  • Any significant ophthalmologic abnormality
  • Unstable systemic disease
  • Coumarins use
  • Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding contraindicating the use of an investigational drug
  • Participants with pre-existing parenchymal lung disease such as pulmonary fibrosis, lymphangiosis carcinomatosis
  • Participants with known infection with human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)
  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): NCT01667562


Locations
Serbia
Clinical Center of Serbia; Institute For Pulmology
Belgrade, Serbia, 11000
Institute for Oncology and Radiology of Serbia; Medical Oncology
Belgrade, Serbia, 11000
Clinical Center Bezanijska Kosa; Oncology
Belgrade, Serbia, 11080
Clinical Center Nis; Clinic for pulmonary diseases Knez Selo
Knez Selo, Serbia, 18000
Institute for pulmonary diseases of Vojvodina
Sremska Kamenica, Serbia, 21204
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01667562     History of Changes
Other Study ID Numbers: ML27860
First Submitted: August 15, 2012
First Posted: August 17, 2012
Last Update Posted: August 29, 2017
Last Verified: August 2017

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


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