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
1 other identifier
interventional
90
5 countries
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2006
Typical duration for phase_2
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2006
CompletedFirst Posted
Study publicly available on registry
April 11, 2006
CompletedStudy Start
First participant enrolled
May 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedJune 7, 2012
June 1, 2012
1.9 years
April 7, 2006
June 5, 2012
Conditions
Outcome Measures
Primary Outcomes (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.
3 months to 2 years from randomization
Secondary Outcomes (9)
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
- +4 more secondary outcomes
Study Arms (2)
Arm A
EXPERIMENTALArm B
ACTIVE COMPARATORInterventions
As per investigator discretion. Excludes chemotherapy or other anti-cancer therapy
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- No other systemic therapy except 1st-line platinum based treatment
- Symptomatic or uncontrolled brain mets or uncontrolled pleural effusions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (26)
Research Site
Bentonville, Arkansas, 72712, United States
Research Site
Fayetteville, Arkansas, 72703, United States
Research Site
Orange, California, 92868, United States
Research Site
Danbury, Connecticut, 06810, United States
Research Site
Atlanta, Georgia, 30309, United States
Research Site
Lexington, Kentucky, 40536-0098, United States
Research Site
Alexandria, Louisiana, 71301, United States
Research Site
New York, New York, 10032, United States
Research Site
Oneida, New York, 13421, United States
Research Site
Oswego, New York, 13126, United States
Research Site
Syracuse, New York, 13202, United States
Research Site
Syracuse, New York, 13210-2306, United States
Research Site
Canton, Ohio, 44718, United States
Research Site
Philadelphia, Pennsylvania, 19111, United States
Research Site
Calgary, Alberta, T2N 4N2, Canada
Research Site
Calgary, Alberta, T2S 3C3, Canada
Research Site
Edmonton, Alberta, T6G 1Z2, Canada
Research Site
Montreal, Quebec, H3T 1E2, Canada
Research Site
Prague, 180 81, Czechia
Research Site
Tábor, 390 03, Czechia
Research Site
Ústí nad Labem, 401 13, Czechia
Research Site
Seoul, 110-744, South Korea
Research Site
Seoul, 135-710, South Korea
Research Site
Seoul, 137-701, South Korea
Research Site
Southampton, Hampshire, SO16 6YD, United Kingdom
Research Site
London, SE1 9RT, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2006
First Posted
April 11, 2006
Study Start
May 1, 2006
Primary Completion
April 1, 2008
Study Completion
February 1, 2010
Last Updated
June 7, 2012
Record last verified: 2012-06