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: September 22, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: erlotinib [Tarceva]
Phase 2

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 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.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: March 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: erlotinib [Tarceva]
150 mg orally daily

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01260181

Locations
Portugal
Aveiro, Portugal, 3814-501
Coimbra, Portugal, 3041-801
Lisboa, Portugal, 1099-023
Lisboa, Portugal, 1150-314
Lisboa, Portugal, 1796-001
Lisboa, Portugal, 1600
Porto, Portugal, 4200
Porto, Portugal, 4200-072
Vila Nova De Gaia, Portugal, 4434-502
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01260181     History of Changes
Other Study ID Numbers: ML25434, 2010-022509-17
Study First Received: December 13, 2010
Last Updated: September 22, 2014
Health Authority: Portugal: National Pharmacy and Medicines Institute (INFARMED)

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
Mitogens
Erlotinib
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 30, 2014