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 April 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01667562
First received: August 15, 2012
Last updated: April 7, 2014
Last verified: April 2014

August 15, 2012
April 7, 2014
January 2012
December 2014   (final data collection date for primary outcome measure)
Progression-free survival [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01667562 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
An Open-Label Study of Tarceva (Erlotinib) in Patients 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 (ESSENCE)

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
Drug: erlotinib [Tarceva]
Daily oral doses of 150 mg administered until disease progression or unacceptable toxicity
Experimental: Tarceva Arm
Intervention: Drug: erlotinib [Tarceva]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Reference Study ID Number: ML27860 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
Serbia
 
NCT01667562
ML27860
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2014

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