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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
Not Enrolling
Both
Carcinoma, Non-small-cell Lung

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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 SiteBentonville, Arkansas  
Research SiteAnaheim, California  
Research SiteDanbury, Connecticut  
Research SiteAlbany, Georgia  
Research SiteAshland, Kentucky  
Research SiteBaton Rouge, Louisiana  
Research SiteAlbany, New York  
Research SiteAkron, Ohio  
Research SiteAllentown, Pennsylvania