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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Carcinoma, Non-small-cell Lung

Intervention / Treatment
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* Drug: CP-675,206
* Drug: best supportive care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br> | Drug: CP-675,206<br>* Given intravenously every 3 months<br>|
| Active Comparator: Arm B<br> | Drug: best supportive care<br>* As per investigator discretion. Excludes chemotherapy or other anti-cancer therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |