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A Randomized, Open Label Study Comparing the Effect of First-line Therapy With Tarceva + Gemcitabine Versus Gemcitabine Monotherapy on Treatment Response in Treatment-naïve Patients With Advanced Non-small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

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Trial Information

A Randomized, Open Label Study Comparing the Effect of First-line Therapy With Tarceva + Gemcitabine Versus Gemcitabine Monotherapy on Treatment Response in Treatment-naïve Patients With Advanced Non-small Cell Lung Cancer


Inclusion Criteria:



- adult patients, >=18 years of age;

- non-small cell lung cancer, stage IIIb (with effusion) or stage IV with measurable
disease ;

- ECOG PS 2;

- adequate organ function.

Exclusion Criteria:

- prior chemotherapy or systemic anti-tumor therapy;

- hypersensitivity to erlotinib;

- any condition contraindicating the use of the study medication and/or impairing the
interpretation of results and/or leading to treatment-related complications.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Time Frame:

Event driven

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Australia: Cancer Trials Australia, Royal Melbourne Hospital

Study ID:

ML20063

NCT ID:

NCT00518011

Start Date:

August 2007

Completion Date:

July 2009

Related Keywords:

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

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