A Randomized, Placebo-controlled, Double-blind Phase III Study of the Effect of First-line Treatment With Intercalated Tarceva Versus Placebo in Combination With Gemcitabine/Platinum on Progression-free Survival in Patients With Stage IIIB/IV Non-small Cell Lung Cancer
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer
Both
Non-Small Cell Lung Cancer
Trial Information
A Randomized, Placebo-controlled, Double-blind Phase III Study of the Effect of First-line Treatment With Intercalated Tarceva Versus Placebo in Combination With Gemcitabine/Platinum on Progression-free Survival in Patients With Stage IIIB/IV Non-small Cell Lung Cancer
Inclusion Criteria:
- adult patients, >=18 years of age;
- advanced (stage IIIB/IV)non-small cell lung cancer;
- measurable disease;
- ECOG Performance Status 0 or 1.
Exclusion Criteria:
- prior exposure to agents directed at the HER axis;
- prior chemotherapy or systemic anti-tumor therapy after advanced disease;
- unstable systemic disease;
- any other malignancy within last 5 years, except cured basal cell cancer of skin or
cured cancer in situ of cervix;
- brain metastasis or spinal cord compression.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival
Outcome Time Frame:
Event driven--tumor assessments every 8 weeks
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Hong Kong: Department of Health
Study ID:
MO22201
NCT ID:
NCT00883779
Start Date:
April 2009
Completion Date:
January 2014
Related Keywords:
- Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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