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