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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


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

up to approximately 2.5 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Latvia: State Agency of Medicines

Study ID:

ML27880

NCT ID:

NCT01609543

Start Date:

May 2012

Completion Date:

December 2015

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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