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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: June 10, 2011
Last updated: September 1, 2015
Last verified: September 2015

This open-label study will assess the efficacy and safety of Tarceva (Erlotinib) in patients with locally advanced, metastatic or recurrent non-small cell lung cancer who have not received previous chemotherapy for their disease and who present epidermal growth factor receptor mutations. Patients will receive Tarceva 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
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, Metastatic or Recurrent 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:
  • Progression-free survival (tumour assessments according to RECIST criteria) [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate (Investigator assessed) [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: January 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Locally advanced (Stage IIIB), metastatic (Stage IV) or recurrent non-small cell lung cancer with mutations in the tyrosine kinase domain of the epidermal growth factor receptor (EGFR)
  • At least one measurable lesion according to RECIST criteria
  • European Cooperative Oncology Group (ECOG) performance status 0-2
  • Adequate hematological, liver and renal function
  • Patients with stable cerebral metastases who have received surgical or radiotherapy will be eligible

Exclusion Criteria:

  • Previous chemotherapy or therapy against EGFR for metastatic disease (neoadjuvant or adjuvant therapy after radical surgery is allowed if finalized >/= 6 months before entering the study)
  • History of another neoplasm except for carcinoma in situ of the cervix, adequately treated basal cell skin carcinoma, radically treated prostate carcinoma with good prognosis (Gleason </= 6), or another curatively treated neoplasm without evidence of disease in the last 5 years
  • Symptomatic cerebral metastases
  • Any significant ophthalmologic abnormality
  • Use of coumarins
  • Pregnant or breast-feeding women
  • Pre-existing parenchymal lung disease such as pulmonary fibrosis, lymphangiosis and carcinomatosis (if this is the only presence of the disease)
  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: NCT01372384

Plovdiv, Bulgaria, 4004
Sofia, Bulgaria, 1527
Sofia, Bulgaria, 1756
Sofia, Bulgaria, 1404
Sofia, Bulgaria, 1431
Stara Zagora, Bulgaria, 8000
Varna, Bulgaria, 9002
Varna, Bulgaria, 9010
Veliko Tarnovo, Bulgaria, 5000
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01372384     History of Changes
Other Study ID Numbers: ML25423
Study First Received: June 10, 2011
Last Updated: September 1, 2015
Health Authority: to: be added

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on October 08, 2015