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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)

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: April 7, 2006
Last updated: June 5, 2012
Last verified: June 2012
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 Intervention Phase
Carcinoma, Non-small-cell Lung
Drug: CP-675,206
Drug: best supportive care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

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

Enrollment: 90
Study Start Date: May 2006
Study Completion Date: February 2010
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00312975

  Show 26 Study Locations
Sponsors and Collaborators
  More Information

Responsible Party: AstraZeneca Identifier: NCT00312975     History of Changes
Other Study ID Numbers: A3671015
Study First Received: April 7, 2006
Last Updated: June 5, 2012

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on April 27, 2017