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A Study of Tarceva (Erlotinib) in First Line in Patients With Locally Advanced or Metastatic Lung Adenocarcinoma With EGFR Mutations

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01609543
First received: May 30, 2012
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

This open-label, non-randomized, one-arm study will evaluate the safety and effi cacy of Tarceva (erlotinib) as single-agent first-line treatment in patients wit h locally advanced or metastatic non-small cell lung cancer who show epidermal g rowth factor receptor (EGFR) activating mutations. Patients will receive Tarceva 150 mg orally daily until disease progression or unacceptable toxicity occurs.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: erlotinib [Tarceva]
Phase 4

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: Open Label Study of Erlotinib (Tarceva®) as Single Agent First Line Treatment of Patients With Locally Advanced or Metastatic Lung Adenocarcinoma With Activating Epidermal Growth Factor Receptor (EGFR) Mutations

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: up to approximately 2.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Objective response rate [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • 1-year survival rate [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: May 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: erlotinib [Tarceva]
150 mg orally daily, until disease progression, unacceptable toxicity or withdrawal due to any reason

  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
  • Histologically or cytologically documented, inoperable, locally advanced, recurrent or metastatic (Stage IIIB or Stage IV) lung adenocarcinoma
  • Non-small cell lung cancer with an EGFR activating mutation
  • Patients must have evidence of disease, but measurable disease is not mandatory
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Adequate renal and liver function

Exclusion Criteria:

  • Prior chemotherapy or other systemic anti-cancer treatment. Neoadjuvant/adjuvant chemotherapy is allowed if completed within 6 months prior to enrolment. Prior radiochemotherapy is allowed if completed more than 6 months before start of study treatment
  • Prior therapy with systemic anti-tumour therapy with HER1/EGFR inhibitors
  • Any other malignancies within 5 years, except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin carcinoma
  • Brain metastasis or spinal cord compression not yet definitely treated with surgery and/or radiation
  • Patients unable to take oral medication or requiring intravenous alimentation, with prior surgical procedures affecting absorption or active peptic ulcer disease
  • Any significant ophthalmologic abnormality, especially those likely to increase the risk of corneal epithelial lesions; the use of contact lenses is not recommended during the study
  • Pregnant or breast-feeding women
  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: NCT01609543

Locations
Hungary
Budapest, Hungary, 1125
Budapest, Hungary, 1529
Debrecen, Hungary, 4032
Deszk, Hungary, 6772
Farkasgyepu, Hungary, 8582
Gyula, Hungary, 5703
Mosonmagyaróvar, Hungary, 9200
Mátraháza, Hungary, 3233
Nyiregyhaza, Hungary, 4400
Pecs, Hungary, 7623
Szekesfehervar, Hungary, 8001
Szekszard, Hungary, 7100
Szolnok, Hungary, 5004
Szombathely, Hungary, 9700
Torokbalint, Hungary, 2045
Törökbálint, Hungary, H-2045
Latvia
Riga, Latvia, LV-1002
Riga, Latvia, LV 1079
Turkey
Ankara, Turkey, 06230
Ankara, Turkey, 06280
Antalya, Turkey, 07070
Edirne, Turkey, 22030
Istanbul, Turkey, 34890
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: NCT01609543     History of Changes
Other Study ID Numbers: ML27880, 2011-002168-26
Study First Received: May 30, 2012
Last Updated: November 3, 2014
Health Authority: Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Erlotinib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014