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

Phase 2

Completed

• Conditions: Carcinoma, Non-small-cell Lung
• Interventions: Drug: CP-675,206; Drug: best supportive care

• Registration Number: NCT00312975
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2006-04-07
• Study First Submitted QC: 2006-04-07
• Study First Posted: 2006-04-11
• Study Start: 2006-05
• Primary Completion: 2008-04
• Disposition First Submitted: 2009-04-20
• Disposition First Submitted QC: 2009-05-07
• Disposition First Posted: 2009-09-28
• Study Completion: 2010-02
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-05
• Last Update Posted: 2012-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

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Exclusion Criteria

• No other systemic therapy except 1st-line platinum based treatment
• Symptomatic or uncontrolled brain mets or uncontrolled pleural effusions.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	CP-675,206	-
Arm B	best supportive care	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇬🇧 London, United Kingdom