An Open-label, Expanded-access Study of the Effect of Tarceva on Treatment Response in Patients With Advanced Stage IIIB/IV Non-small-cell Lung Cancer
Phase 4
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer
Both
Non-Small Cell Lung Cancer
Trial Information
An Open-label, Expanded-access Study of the Effect of Tarceva on Treatment Response in Patients With Advanced Stage IIIB/IV Non-small-cell Lung Cancer
Inclusion Criteria:
- adult patients >=18 years of age;
- histologically or cytologically documented inoperable, locally advanced, metastatic,
or recurrent NSCLC;
- previous treatment with <=2 prior chemotherapy regimens.
Exclusion Criteria:
- previous systemic anti-cancer therapy with HER1/EGFR inhibitors;
- inability to take oral medication;
- any other malignancies within 5 years.
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:
Safety:Adverse events, serious adverse events, premature withdrawals\n\n
Outcome Time Frame:
At each clinic visit, throughout study.Length of study not specified
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Chair
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Netherlands:Medicines Evaluation Board
Study ID:
MO18109
NCT ID:
NCT00949910
Start Date:
November 2004
Completion Date:
August 2011
Related Keywords:
- Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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