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The primary purpose of this study is to estimate the number of patients with non-small cell lung cancer whose tumor responds to the treatments given in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator |
| |
| B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetuximab + platinum + gemcitabine | Drug | Solution, IV, Cetuximab: 400mg/m2 on Day 1 then given weekly at 250mg/m2 starting on Day 8 + Gemcitabine given at 1250mg/m2 (Day 1 & Day 8 of each cycle) + Cisplatin given at 75mg/m2 or Carboplatin AUC=5, Cycle of therapy is every 3 weeks. Cetuximab is given weekly, Maximum of 6 cycles (18 weeks) Cetuximab will be continued during the period following discontinuation of chemotherapy, until disease progression or cetuximab intolerance. |
| Measure | Description | Time Frame |
|---|---|---|
| tumor response per treatment arm |
| Measure | Description | Time Frame |
|---|---|---|
| disease control, symptom response, symptomatic progression, & progression free survival. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Mobile | Alabama | United States | |||
| Local Institution |
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|
| Platinum + Gemcitabine | Drug | Solution, IV, Gemcitabine given at 1250mg/m2 (Day 1 & Day 8 of each cycle) + Cisplatin given at 75mg/m2 or Carboplatin AUC=5, Cycle of therapy is every 3 weeks, Maximum of 6 cycles = 18 weeks. |
|
| Anchorage |
| Alaska |
| United States |
| Local Institution | Bakersfield | California | United States |
| Local Institution | Corona | California | United States |
| Local Institution | Oxnard | California | United States |
| Local Institution | San Diego | California | United States |
| Local Institution | Whittier | California | United States |
| Local Institution | Lakewood | Colorado | United States |
| Local Institution | Boynton Beach | Florida | United States |
| Local Institution | Brooksville | Florida | United States |
| Local Institution | Inverness | Florida | United States |
| Local Institution | Pembroke Pines | Florida | United States |
| Local Institution | Austell | Georgia | United States |
| Local Institution | Honolulu | Hawaii | United States |
| Local Institution | Skokie | Illinois | United States |
| Local Institution | Muncie | Indiana | United States |
| Local Institution | Annapolis | Maryland | United States |
| Local Institution | Frederick | Maryland | United States |
| Local Institution | Rockville | Maryland | United States |
| Local Institution | Plymouth | Massachusetts | United States |
| Local Institution | Farmington | New Mexico | United States |
| Local Institution | Armonk | New York | United States |
| Local Institution | Stony Brook | New York | United States |
| Local Institution | Gastonia | North Carolina | United States |
| Local Institution | Wilmington | North Carolina | United States |
| Local Institution | Bismarck | North Dakota | United States |
| Local Institution | Cincinnati | Ohio | United States |
| Local Institution | Portland | Oregon | United States |
| Local Institution | Charleston | South Carolina | United States |
| Local Institution | Dallas | Texas | United States |
| Local Institution | Vancouver | Washington | United States |
| Local Institution | Edmonton | Alberta | Canada |
| Local Institution | Moncton | New Brunswick | Canada |
| Local Institution | Hamilton | Ontario | Canada |
| Local Institution | Montreal | Ontario | Canada |
| Local Institution | Toronto | Ontario | Canada |
| Local Institution | Windsor | Ontario | Canada |
| Local Institution | Greenfield Park | Quebec | Canada |
| 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 |
|---|---|
| D000068818 | Cetuximab |
| D010984 | Platinum |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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