Randomized Study Of CP-675,206 or Best Supportive Care Immediately After Platinum-Based Therapy For Non-Small Cell Lung Cancer (NSCLC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00312975
First received: April 7, 2006
Last updated: June 5, 2012
Last verified: June 2012

April 7, 2006
June 5, 2012
May 2006
April 2008   (final data collection date for primary 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. [ Time Frame: 3 months to 2 years from randomization ] [ Designated as safety issue: No ]
The main outcome is to measure the length of time until their evidence of disease progression in patients ticilimumab and in patients supportive care. Historically, this has been approximately 3 months
Complete list of historical versions of study NCT00312975 on ClinicalTrials.gov Archive Site
  • Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Levels of study drug in blood samples taken at specified time points. [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
  • Whether polymorphisms of certain genes influence safety. [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
  • Health-related quality of life outcomes. [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
  • Tumor response [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
  • Number of patients with adverse events as a measure of safety of CP-675,206 when administered to patients with NSCLC [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
  • Blood levels of any human anti-human antibody response [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
  • Immune response. [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
  • Efficacy [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
  • Other outcomes include: measuring survival, tumor response,
  • safety of ticilimumab when administered to patients with NSCLC,
  • to obtain blood samples for measure the study drug in blood,
  • monitor for a human anti-human antibody response,
  • to explore whether polymorphisms of certain genes influence safety,
  • immune response or efficacy
  • and to explore health-related quality of life outcomes.
Not Provided
Not Provided
 
Randomized Study Of CP-675,206 or Best Supportive Care Immediately After Platinum-Based Therapy For Non-Small Cell Lung Cancer (NSCLC)
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

The purpose of this trial is to study how long patients can remain progression free when they receive CP-675,206, compared to how long patients can remain progression free when they receive best supportive care. If you choose to take part, you will be randomized to receive either CP-675,206 as maintenance therapy or best supportive care. Best supportive care means you will not receive any study drug or other treatment for your cancer. Best supportive care could include treatment with antibiotics, analgesic drugs (medicine for pain), blood transfusions or psychosocial and nutritional support, depending on your needs. You have a 50% chance of being randomized to receive CP-675,206.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Non-small-cell Lung
  • Drug: CP-675,206
    Given intravenously every 3 months
  • Drug: best supportive care
    As per investigator discretion. Excludes chemotherapy or other anti-cancer therapy
  • Experimental: Arm A
    Intervention: Drug: CP-675,206
  • Active Comparator: Arm B
    Intervention: Drug: best supportive care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
February 2010
April 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Czech Republic,   Korea, Republic of,   United Kingdom
 
NCT00312975
A3671015
No
AstraZeneca
AstraZeneca
Not Provided
Not Provided
AstraZeneca
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP