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.

Study Overview

• Status: Completed
• Conditions: Carcinoma, Non-small-cell Lung
• Intervention / Treatment: Drug: CP-675,206; Drug: best supportive care

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Research Site
    • Calgary, Alberta, Canada, T2S 3C3
      • Research Site
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Research Site
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Research Site
• Czech Republic
  • Praha 8, Czech Republic, 180 81
    • Research Site
  • Tabor, Czech Republic, 390 03
    • Research Site
  • Usti nad Labem, Czech Republic, 401 13
    • Research Site
• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Research Site
  • Seoul, Korea, Republic of, 137-701
    • Research Site
  • Seoul, Korea, Republic of, 110-744
    • Research Site
• United Kingdom
  • London, United Kingdom, SE1 9RT
    • Research Site
  • Hampshire
    • Southampton, Hampshire, United Kingdom, SO16 6YD
      • Research Site
• United States
  • Arkansas
    • Bentonville, Arkansas, United States, 72712
      • Research Site
    • Fayetteville, Arkansas, United States, 72703
      • Research Site
  • California
    • Orange, California, United States, 92868
      • Research Site
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Research Site
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Research Site
  • Kentucky
    • Lexington, Kentucky, United States, 40536-0098
      • Research Site
  • Louisiana
    • Alexandria, Louisiana, United States, 71301
      • Research Site
  • New York
    • New York, New York, United States, 10032
      • Research Site
    • Oneida, New York, United States, 13421
      • Research Site
    • Oswego, New York, United States, 13126
      • Research Site
    • Syracuse, New York, United States, 13202
      • Research Site
    • Syracuse, New York, United States, 13210-2306
      • Research Site
  • Ohio
    • Canton, Ohio, United States, 44718
      • Research Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	3 months to 2 years from randomization

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: April 7, 2006
• First Submitted That Met QC Criteria: April 7, 2006
• First Posted (Estimate): April 11, 2006

Study Record Updates

• Last Update Posted (Estimate): June 7, 2012
• Last Update Submitted That Met QC Criteria: June 5, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents; Tremelimumab
• Other Study ID Numbers: A3671015