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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental |
| |
| Arm B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP-675,206 | Drug | Given intravenously every 3 months |
| |
| best supportive care |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Bentonville | Arkansas | 72712 | United States | ||
| Research Site |
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| Drug |
As per investigator discretion. Excludes chemotherapy or other anti-cancer therapy |
|
| 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 |
| 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 |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C520704 | tremelimumab |
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