Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: May 30, 2012
Last updated: January 19, 2015
Last verified: January 2015

May 30, 2012
January 19, 2015
May 2012
January 2015   (final data collection date for primary outcome measure)
Progression-free survival [ Time Frame: up to approximately 2.5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01609543 on Archive Site
  • 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 ]
  • 1-year survival [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
A Study of Tarceva (Erlotinib) in First Line in Patients With Locally Advanced or Metastatic Lung Adenocarcinoma With EGFR Mutations
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

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.

Not Provided
Phase 4
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, until disease progression, unacceptable toxicity or withdrawal due to any reason
Experimental: Single Arm
Intervention: Drug: erlotinib [Tarceva]
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
January 2015
January 2015   (final data collection date for primary outcome measure)

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
18 Years and older
Contact information is only displayed when the study is recruiting subjects
Hungary,   Latvia,   Turkey
ML27880, 2011-002168-26
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
January 2015

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