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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:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01667562
First received: August 15, 2012
Last updated: May 16, 2017
Last verified: May 2017

August 15, 2012
May 16, 2017
January 20, 2012
June 30, 2017   (Final data collection date for primary outcome measure)
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) ]
Progression-free survival [ Time Frame: Approximately 2 years ]
Complete list of historical versions of study NCT01667562 on ClinicalTrials.gov Archive Site
  • 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) ]
  • Response rate [ Time Frame: Approximately 2 years ]
  • Safety: incidence of adverse events [ Time Frame: Approximately 2 years ]
  • Incidence of epidermal growth factor receptor mutations in patients [ Time Frame: Approximately 2 years ]
  • Quality of life [ Time Frame: Approximately 2 years ]
Not Provided
Not Provided
 
A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
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
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.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
Drug: Erlotinib
Daily oral doses administered until disease progression or unacceptable toxicity or death.
Other Name: Tarceva
Experimental: Erlotinib
Erlotinib will be administered as a single daily oral dose of 150 milligrams until disease progression, death or unacceptable toxicity.
Intervention: Drug: Erlotinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
June 30, 2017
June 30, 2017   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Serbia
 
 
NCT01667562
ML27860
Not Provided
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP