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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 (EGFR) - (TRIGGER)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer

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Trial Information

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 (EGFR) - (TRIGGER)


Inclusion Criteria:



- Adult patients, >/=18 years of age

- Locally advanced or metastatic non-small cell lung cancer

- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- Life expectancy over >/=12 weeks

- Adequate hematological, liver, or kidney function

Exclusion Criteria:

- Previous therapy against epidermal growth factor receptor for metastatic disease

- Treatment with investigational drug during the 3 weeks before enrollment

- History of neoplasm

- Patients with symptomatic cerebral metastases

- Unstable systemic disease

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:

12 months

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Italy: Ministry of Health

Study ID:

ML25514

NCT ID:

NCT01378962

Start Date:

March 2011

Completion Date:

June 2013

Related Keywords:

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

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