A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Mutations

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01260181
First received: December 13, 2010
Last updated: August 26, 2014
Last verified: August 2014

December 13, 2010
August 26, 2014
March 2011
December 2014   (final data collection date for primary outcome measure)
Overall Response Rate: tumour assessments by computer tomography (CT) or magnetic resonance imaging (MRI) according to RECIST 1.1 criteria [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01260181 on ClinicalTrials.gov Archive Site
  • Response duration [ Time Frame: Approximately 3.5 years ] [ Designated as safety issue: No ]
  • Progression-free survival: tumour assessments by CT or MRI according to RECIST 1.1 criteria [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Epidermal Growth Factor Receptor (EGFR) mutation rate in study population, assessed at screening [ Time Frame: approximately 12 months ] [ Designated as safety issue: No ]
  • Progression-free survival: tumour assessments by CT or MRI according to RECIST 1.1 criteria [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Epidermal Growth Factor Receptor (EGFR) mutation rate in study population, assessed at screening [ Time Frame: approximately 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Mutations
Phase II, 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 single arm, open-label study will evaluate the efficacy and safety of Tarce va (erlotinib) in patients with locally advanced or metastatic non-small cell lu ng cancer with epidermal growth factor receptor (EGFR) mutations. Patients will receive Tarceva at a dose of 150 mg orally daily until disease progression or un acceptable toxicity occurs.

Not Provided
Interventional
Phase 2
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]
150 mg orally daily
Experimental: Single 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.
 
Active, not recruiting
30
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Locally advanced or metastatic non-small cell lung cancer with EGFR mutations
  • Measurable disease according to RECIST criteria
  • Adequate haematological, renal and liver function

Exclusion Criteria:

  • Previous chemotherapy or therapy against EGFR for metastatic disease
  • Symptomatic cerebral metastases
  • Pre-existing disease of the lung parenchyma such as lung fibrosis, lymphangitic carcinomatosis
  • History of another malignancy except for carcinoma in-situ of the cervix, adequately treated basal cell skin carcinoma, or radically treated prostate carcinoma with good prognosis
  • Concomitant use of coumarins
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Portugal
 
NCT01260181
ML25434, 2010-022509-17
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

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