Phase 2 Randomized, Non-Comparative Study Of CP-675,206 Or Best Supportive Care Immediately Following First-Line, Platinum-Based Therapy In Patients With Stage IIIB (With Effusion) Or Stage IV Non-Small Cell Lung Cancer That Has Responded Or Remained Stable
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-small-cell Lung
Both
Carcinoma, Non-small-cell Lung
Trial Information
Phase 2 Randomized, Non-Comparative Study Of CP-675,206 Or Best Supportive Care Immediately Following First-Line, Platinum-Based Therapy In Patients With Stage IIIB (With Effusion) Or Stage IV Non-Small Cell Lung Cancer That Has Responded Or Remained Stable
Inclusion Criteria:
- Stage IIIb (with effusion) or stage IV disease that has responded or remained stable
after 6 cycles of a platinum containing 1st-line regimen
- Patients must be able to be randomized between 3 and no more than 6 weeks after the
last dose of first-line therapy.
Exclusion Criteria:
- No other systemic therapy except 1st-line platinum based treatment
- Symptomatic or uncontrolled brain mets or uncontrolled pleural effusions.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The length of time until there is evidence of disease progression in patients treated with CP-675,206 and in patients receiving best supportive care.
Outcome Time Frame:
3 months to 2 years from randomization
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
A3671015
NCT ID:
NCT00312975
Start Date:
May 2006
Completion Date:
February 2010
Related Keywords:
- Carcinoma, Non-Small-Cell Lung
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Research Site | Bentonville, Arkansas |
| Research Site | Anaheim, California |
| Research Site | Danbury, Connecticut |
| Research Site | Albany, Georgia |
| Research Site | Ashland, Kentucky |
| Research Site | Baton Rouge, Louisiana |
| Research Site | Albany, New York |
| Research Site | Akron, Ohio |
| Research Site | Allentown, Pennsylvania |
