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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00312975
Recruitment Status : Completed
First Posted : April 11, 2006
Last Update Posted : June 7, 2012
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-small-cell Lung Drug: CP-675,206 Drug: best supportive care Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Arm A Drug: CP-675,206
Given intravenously every 3 months

Active Comparator: Arm B Drug: best supportive care
As per investigator discretion. Excludes chemotherapy or other anti-cancer therapy

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Survival [ Time Frame: 2 years ]
  2. Levels of study drug in blood samples taken at specified time points. [ Time Frame: up to 2 years ]
  3. Whether polymorphisms of certain genes influence safety. [ Time Frame: up to 2 years ]
  4. Health-related quality of life outcomes. [ Time Frame: up to 2 years ]
  5. Tumor response [ Time Frame: up to 2 years ]
  6. 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 ]
  7. Blood levels of any human anti-human antibody response [ Time Frame: up to 2 years ]
  8. Immune response. [ Time Frame: up to 2 years ]
  9. Efficacy [ Time Frame: up to 2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00312975

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Sponsors and Collaborators

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Responsible Party: AstraZeneca Identifier: NCT00312975     History of Changes
Other Study ID Numbers: A3671015
First Posted: April 11, 2006    Key Record Dates
Last Update Posted: June 7, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Antineoplastic Agents, Immunological