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Phase 4
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

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Trial Information


Inclusion Criteria:



- adult patients >= 18 years of age;

- inoperable, locally advanced, recurrent or metastatic (Stage IIIB/IV) non-small cell
lung cancer;

- ECOG performance status of 0-3;

- previously untreated, or failed on one prior course of standard systemic chemotherapy
and/or radiotherapy.

Exclusion Criteria:

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

- unstable systemic disease;

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

- any significant ophthalmologic abnormality.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Incidence of adverse events (AEs)

Outcome Time Frame:

Length of patient on study (length of time of patient on study determined by investigator)

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Russia: Ministry of Health

Study ID:

ML20569

NCT ID:

NCT01066884

Start Date:

April 2009

Completion Date:

December 2010

Related Keywords:

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

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