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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.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: December 13, 2010
Last updated: November 1, 2016
Last verified: November 2016
This single arm, open-label study will evaluate the efficacy and safety of Tarceva (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations. Patients will receive Tarceva at a dose of 150 mg orally daily until disease progression or unacceptable toxicity occurs.

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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 ]

Secondary Outcome Measures:
  • Progression-free survival: tumour assessments by CT or MRI according to RECIST 1.1 criteria [ Time Frame: approximately 3.5 years ]
  • Overall survival [ Time Frame: approximately 3.5 years ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 3.5 years ]
  • Epidermal Growth Factor Receptor (EGFR) mutation rate in study population, assessed at screening [ Time Frame: approximately 12 months ]
  • Response duration [ Time Frame: Approximately 3.5 years ]

Enrollment: 30
Study Start Date: March 2011
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: erlotinib [Tarceva]
150 mg orally daily


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT01260181

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

Responsible Party: Hoffmann-La Roche Identifier: NCT01260181     History of Changes
Other Study ID Numbers: ML25434  2010-022509-17 
Study First Received: December 13, 2010
Last Updated: November 1, 2016

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Mitosis Modulators processed this record on February 24, 2017