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An Open Label Study to Evaluate the Effect of First Line Treatment With Tarceva in Combination With Gemcitabine on Disease Progression in Patients With Unresectable Advanced and/or Metastatic 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

An Open Label Study to Evaluate the Effect of First Line Treatment With Tarceva in Combination With Gemcitabine on Disease Progression in Patients With Unresectable Advanced and/or Metastatic Non-small Cell Lung Cancer


Inclusion Criteria:



- adult patients, >=18 years of age;

- advanced and/or metastatic (stage IIIB/IV) unresectable non-small cell lung cancer;

- no previous systemic chemotherapy, radiation therapy or immunotherapy;

- ECOG >=2.

Exclusion Criteria:

- prior systemic anti-tumor therapy with HER1/EGFR inhibitors;

- active, non-controlled systemic disease;

- any other malignancies within 5 years (except for adequately treated cancer in situ
of cervix, or basal or squamous cell skin cancer).

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:

Time to disease progression; pathological response rate.

Outcome Time Frame:

Event driven

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Romania: National Medicines Agency

Study ID:

ML20951

NCT ID:

NCT00701558

Start Date:

August 2008

Completion Date:

August 2011

Related Keywords:

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

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