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To assess the efficacy and safety of PF-3512676 administered in combination with erlotinib in patients with advanced EGFR-positive non-small cell lung cancer after failure of at least one prior chemotherapy regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Standard of Care chemotherapy plus experimental intervention (PF-3512676) |
|
| B | Active Comparator | Standard of Care chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-3512676 + Erlotinib | Drug | PF-3512676 0.2 mg/kg subcutaneously on days 1, 8 and 15 of each 21 day cycle until disease progression or unacceptable toxicity. Erlotinib 150 mg orally daily (21 day cycles) until disease progression or unacceptable toxicity |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival | 50Events |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Safety Profile | 28 days post treatment | |
| Time to Tumor Progression | End of treatment | |
| Overall Objective Response Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Daphne | Alabama | 36526 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23792641 | Derived | Belani CP, Nemunaitis JJ, Chachoua A, Eisenberg PD, Raez LE, Cuevas JD, Mather CB, Benner RJ, Meech SJ. Phase 2 trial of erlotinib with or without PF-3512676 (CPG 7909, a Toll-like receptor 9 agonist) in patients with advanced recurrent EGFR-positive non-small cell lung cancer. Cancer Biol Ther. 2013 Jul;14(7):557-63. doi: 10.4161/cbt.24598. Epub 2013 May 10. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Erlotinib | Drug | Erlotinib 150 mg orally daily (21 day cycles) until disease progression or unacceptable toxicity |
|
|
| Time of disease progression |
| Duration of Response | Time of disease progression |
| Overall Survival | Time of death |
| Huntsville |
| Alabama |
| 35805 |
| United States |
| Pfizer Investigational Site | Mobile | Alabama | 36608 | United States |
| Pfizer Investigational Site | Corona | California | 92879 | United States |
| Pfizer Investigational Site | Glendora | California | 91741 | United States |
| Pfizer Investigational Site | Greenbrae | California | 94904 | United States |
| Pfizer Investigational Site | Pasadena | California | 91105 | United States |
| Pfizer Investigational Site | Pomona | California | 91767 | United States |
| Pfizer Investigational Site | Rancho Cucamonga | California | 91730 | United States |
| Pfizer Investigational Site | San Mateo | California | 94402 | United States |
| Pfizer Investigational Site | West Covina | California | 91790 | United States |
| Pfizer Investigational Site | Norwalk | Connecticut | 06856 | United States |
| Pfizer Investigational Site | Deerfield Beach | Florida | 33442 | United States |
| Pfizer Investigational Site | Melbourne | Florida | 32901 | United States |
| Pfizer Investigational Site | Miami | Florida | 33136 | United States |
| Pfizer Investigational Site | Munster | Indiana | 46321 | United States |
| Pfizer Investigational Site | Mason City | Iowa | 50401 | United States |
| Pfizer Investigational Site | Crestview Hills | Kentucky | 41017 | United States |
| Pfizer Investigational Site | Louisville | Kentucky | 40202 | United States |
| Pfizer Investigational Site | Bridgeton | Missouri | 63044 | United States |
| Pfizer Investigational Site | Chesterfield | Missouri | 63017 | United States |
| Pfizer Investigational Site | Kirkwood | Missouri | 63122 | United States |
| Pfizer Investigational Site | Somerville | New Jersey | 08876 | United States |
| Pfizer Investigational Site | New York | New York | 10016 | United States |
| Pfizer Investigational Site | Stony Brook | New York | 11794 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45209 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45219 | United States |
| Pfizer Investigational Site | Fairfield | Ohio | 45014 | United States |
| Pfizer Investigational Site | Hershey | Pennsylvania | 17033-0850 | United States |
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19104 | United States |
| Pfizer Investigational Site | Philadephia | Pennsylvania | 19104 | United States |
| Pfizer Investigational Site | Kingsport | Tennessee | 37660 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75230 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75246 | United States |
| Pfizer Investigational Site | Dalls | Texas | 75246 | United States |
| 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 |
|---|---|
| C483020 | ProMune |
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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