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See Termination Reason in Detailed Description
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To assess the efficacy and safety of PF-3512676 administered in combination with paclitaxel/carboplatin chemotherapy as first-line treatment in patients with locally advanced or metastatic Non-Small-Cell Lung Cancer (NSCLC) and to compare it to the efficacy and safety of paclitaxel
PF-3512676 dosing was stopped 20 June 2007 in response to DSMC recommendation to close the trial, citing lack of efficacy concerns as the primary reason with a safety issue (sepsis) also contributing to the decision. Subjects were allowed to complete standard of care treatment/survival follow-up. Data collection was completed on 17 July 2008.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Standard of care chemotherapy plus experiment intervention (PF-3512676) |
|
| B | Active Comparator | Standard of care chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-3512676 + Paclitaxel + Carboplatin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 656 Events |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Objective Response | End of Treatment | |
| Time to Tumor Progression | Time of progressive disease | |
| Progression Free Survival |
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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 | Little Rock | Alaska | 72205 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41332393 | Derived | Roeland EJ, Fintelmann FJ, Yang R, Tarasenko L, Bonomi PD. Evaluation of Weight Gain and Overall Survival of Men Versus Women With Advanced Non-Small Cell Lung Cancer. J Cachexia Sarcopenia Muscle. 2025 Dec;16(6):e70131. doi: 10.1002/jcsm.70131. | |
| 38468440 | Derived | Roeland EJ, Fintelmann FJ, Hilton F, Yang R, Whalen E, Tarasenko L, Calle RA, Bonomi PD. The relationship between weight gain during chemotherapy and outcomes in patients with advanced non-small cell lung cancer. J Cachexia Sarcopenia Muscle. 2024 Jun;15(3):1030-1040. doi: 10.1002/jcsm.13426. Epub 2024 Mar 11. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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|
|
| Paclitaxel + Carboplatin | Drug |
|
|
|
| Time of primary endpoint |
| Duration of Response | Time of progressive disease |
| Patient Reported Outcomes | End of Treatment |
| Overall Safety Profile | 28 days post PF-3512676 dosing |
| Hot Springs |
| Arkansas |
| 71913 |
| United States |
| Pfizer Investigational Site | Chula Vista | California | 91911 | United States |
| Pfizer Investigational Site | La Mesa | California | 91942 | United States |
| Pfizer Investigational Site | Oceanside | California | 92056 | United States |
| Pfizer Investigational Site | Palm Springs | California | 92262-4885 | United States |
| Pfizer Investigational Site | San Diego | California | 92123 | United States |
| Pfizer Investigational Site | San Francisco | California | 94115 | United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30306 | United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30308 | United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30309 | United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30322 | United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30342 | United States |
| Pfizer Investigational Site | Decatur | Georgia | 30033 | United States |
| Pfizer Investigational Site | Fayetteville | Georgia | 30214 | United States |
| Pfizer Investigational Site | Macon | Georgia | 31217 | United States |
| Pfizer Investigational Site | Marietta | Georgia | 30060 | United States |
| Pfizer Investigational Site | Tucker | Georgia | 30084 | United States |
| Pfizer Investigational Site | Rockford | Illinois | 61104 | United States |
| Pfizer Investigational Site | Jefferson | Indiana | 47130 | United States |
| Pfizer Investigational Site | New Albany | Indiana | 47150-6809 | United States |
| Pfizer Investigational Site | Cedar Rapids | Iowa | 52403 | United States |
| Pfizer Investigational Site | Dubuque | Iowa | 52001 | United States |
| Pfizer Investigational Site | Lexington | Kentucky | 40503 | United States |
| Pfizer Investigational Site | Louisville | Kentucky | 40202 | United States |
| Pfizer Investigational Site | Louisville | Kentucky | 40217 | United States |
| Pfizer Investigational Site | Louisville | Kentucky | 40241 | United States |
| Pfizer Investigational Site | Louisville | Kentucky | 40505-4816 | United States |
| Pfizer Investigational Site | Shelbyville | Kentucky | 40065 | United States |
| Pfizer Investigational Site | Covington | Louisiana | 70433 | United States |
| Pfizer Investigational Site | Gretna | Louisiana | 70056 | United States |
| Pfizer Investigational Site | Lafayette | Louisiana | 70503 | United States |
| Pfizer Investigational Site | Marrero | Louisiana | 70006 | United States |
| Pfizer Investigational Site | Marrero | Louisiana | 70072 | United States |
| Pfizer Investigational Site | Metairie | Louisiana | 70006 | United States |
| Pfizer Investigational Site | New Orleans | Louisiana | 70115 | United States |
| Pfizer Investigational Site | Biddeford | Maine | 04005 | United States |
| Pfizer Investigational Site | Brunswick | Maine | 04011 | United States |
| Pfizer Investigational Site | Scarborough | Maine | 04074 | United States |
| Pfizer Investigational Site | Worcester | Massachusetts | 01608 | United States |
| Pfizer Investigational Site | Allegan | Michigan | 49010 | United States |
| Pfizer Investigational Site | Ann Arbor | Michigan | 48109-0848 | United States |
| Pfizer Investigational Site | Ann Arbor | Michigan | 48109 | United States |
| Pfizer Investigational Site | Kalamazoo | Michigan | 49007 | United States |
| Pfizer Investigational Site | Kalamazoo | Michigan | 49048 | United States |
| Pfizer Investigational Site | Saint Joseph | Michigan | 49085 | United States |
| Pfizer Investigational Site | Columbus | Mississippi | 39705 | United States |
| Pfizer Investigational Site | Corinth | Mississippi | 38834 | United States |
| Pfizer Investigational Site | Tupelo | Mississippi | 38801 | United States |
| Pfizer Investigational Site | Omaha | Nebraska | 68114 | United States |
| Pfizer Investigational Site | Omaha | Nebraska | 68124 | United States |
| Pfizer Investigational Site | Omaha | Nebraska | 68130 | United States |
| Pfizer Investigational Site | Papillion | Nebraska | 68046 | United States |
| Pfizer Investigational Site | Las Vegas | Nevada | 89102 | United States |
| Pfizer Investigational Site | Las Vegas | Nevada | 89106 | United States |
| Pfizer Investigational Site | Albuquerque | New Mexico | 87109 | United States |
| Pfizer Investigational Site | Ruidoso | New Mexico | 88345 | United States |
| Pfizer Investigational Site | Buffalo | New York | 14263 | United States |
| Pfizer Investigational Site | Great Neck | New York | 11023 | United States |
| Pfizer Investigational Site | Asheville | North Carolina | 28801 | United States |
| Pfizer Investigational Site | Brevard | North Carolina | 28712 | United States |
| Pfizer Investigational Site | Lexington | North Carolina | 27292 | United States |
| Pfizer Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| Pfizer Investigational Site | Canton | Ohio | 44718 | United States |
| Pfizer Investigational Site | Dover | Ohio | 44622 | United States |
| Pfizer Investigational Site | Oklahoma City | Oklahoma | 73112-4491 | United States |
| Pfizer Investigational Site | Portland | Oregon | 97227-1191 | United States |
| Pfizer Investigational Site | Langhorne | Pennsylvania | 19047 | United States |
| Pfizer Investigational Site | Chattanooga | Tennessee | 37404-3324 | United States |
| Pfizer Investigational Site | Memphis | Tennessee | 38120 | United States |
| Pfizer Investigational Site | Arlington | Texas | 76012 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75230 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75235-7786 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75235 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75390-8590 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75390-9015 | United States |
| Pfizer Investigational Site | Richardson | Texas | 75080 | United States |
| Pfizer Investigational Site | Trophy Club | Texas | 76262 | United States |
| Pfizer Investigational Site | Bountiful | Utah | 84010 | United States |
| Pfizer Investigational Site | Layton | Utah | 84041 | United States |
| Pfizer Investigational Site | Murray | Utah | 84107 | United States |
| Pfizer Investigational Site | Provo | Utah | 84604 | United States |
| Pfizer Investigational Site | Salt Lake City | Utah | 84106 | United States |
| Pfizer Investigational Site | WVC | Utah | 84120 | United States |
| Pfizer Investigational Site | Burlington | Vermont | 05401 | United States |
| Pfizer Investigational Site | Everett | Washington | 98201 | United States |
| Pfizer Investigational Site | Kennewick | Washington | 99336 | United States |
| Pfizer Investigational Site | Richland | Washington | 99352 | United States |
| Pfizer Investigational Site | Madison | Wisconsin | 53792-5666 | United States |
| Pfizer Investigational Site | Albury | New South Wales | 2640 | Australia |
| Pfizer Investigational Site | Camperdown | New South Wales | 2050 | Australia |
| Pfizer Investigational Site | Randwick | New South Wales | 2031 | Australia |
| Pfizer Investigational Site | Pimlico | Queensland | 4812 | Australia |
| Pfizer Investigational Site | Townsville | Queensland | 4814 | Australia |
| Pfizer Investigational Site | Woolloongabba | Queensland | 4102 | Australia |
| Pfizer Investigational Site | Bedford Park | South Australia | 5042 | Australia |
| Pfizer Investigational Site | Toorak Gardens | South Australia | 5065 | Australia |
| Pfizer Investigational Site | East Melbourne | Victoria | 3002 | Australia |
| Pfizer Investigational Site | East Ringwood | Victoria | 3135 | Australia |
| Pfizer Investigational Site | Wodonga | Victoria | 3690 | Australia |
| Pfizer Investigational Site | Nedlands | Western Australia | 6009 | Australia |
| Pfizer Investigational Site | Ghent | 9000 | Belgium |
| Pfizer Investigational Site | Liège | 4000 | Belgium |
| Pfizer Investigational Site | Moncton | New Brunswick | E1C 6Z8 | Canada |
| Pfizer Investigational Site | Montreal | Quebec | H2A 1A1 | Canada |
| Pfizer Investigational Site | Montreal | Quebec | H3G 1A4 | Canada |
| Pfizer Investigational Site | Montreal | Quebec | H3T 1E2 | Canada |
| Pfizer Investigational Site | Montreal | Quebec | H3T 1M5 | Canada |
| Pfizer Investigational Site | Rimouski | Quebec | G5L 5T1 | Canada |
| Pfizer Investigational Site | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
| Pfizer Investigational Site | Dalian, Xigang District | Liaoning | 116011 | China |
| Pfizer Investigational Site | Beijing | 100021 | China |
| Pfizer Investigational Site | Beijing | 100071 | China |
| Pfizer Investigational Site | Shanghai | 200032 | China |
| Pfizer Investigational Site | Nicosia | 2006 | Cyprus |
| Pfizer Investigational Site | Nová Ves pod Pleší | 26204 | Czechia |
| Pfizer Investigational Site | Ostrava-Poruba | 708 52 | Czechia |
| Pfizer Investigational Site | Ústí nad Labem | 401 13 | Czechia |
| Pfizer Investigational Site | Angers | 49033 | France |
| Pfizer Investigational Site | Caen | 14033 | France |
| Pfizer Investigational Site | Dijon | France |
| Pfizer Investigational Site | Limoges | 87042 | France |
| Pfizer Investigational Site | Nantes | 44202 | France |
| Pfizer Investigational Site | Paris | 75651 | France |
| Pfizer Investigational Site | Saint-Herblain | 44805 | France |
| Pfizer Investigational Site | Strasbourg | 67065 Cedex | France |
| Pfizer Investigational Site | Toulouse | 31059 | France |
| Pfizer Investigational Site | Vandœuvre-lès-Nancy | 54511 | France |
| Pfizer Investigational Site | Berlin | 10117 | Germany |
| Pfizer Investigational Site | Bielefeld | 33611 | Germany |
| Pfizer Investigational Site | Bonn | 53105 | Germany |
| Pfizer Investigational Site | Essen | 45122 | Germany |
| Pfizer Investigational Site | Frankfurt | 60590 | Germany |
| Pfizer Investigational Site | Karlsruhe | 76137 | Germany |
| Pfizer Investigational Site | München | 80336 | Germany |
| Pfizer Investigational Site | Athens | Attica | 11526 | Greece |
| Pfizer Investigational Site | Heraklion | Crete | 71 500 | Greece |
| Pfizer Investigational Site | Thessaloniki | Macedonia | 56 403 | Greece |
| Pfizer Investigational Site | Athens | 115 27 | Greece |
| Pfizer Investigational Site | Rio, Patras | 26500 | Greece |
| Pfizer Investigational Site | Pokfulam | Hong Kong |
| Pfizer Investigational Site | Budapest | 1122 | Hungary |
| Pfizer Investigational Site | Budapest | 1125 | Hungary |
| Pfizer Investigational Site | Budapest | 1529 | Hungary |
| Pfizer Investigational Site | Debrecen | 4032 | Hungary |
| Pfizer Investigational Site | Bangalore | Karnataka | 560 034 | India |
| Pfizer Investigational Site | Kochi | Kerala | 682 026 | India |
| Pfizer Investigational Site | Pune | Maharashtra | 411 001 | India |
| Pfizer Investigational Site | Chandigarh | Punjab | 160 012 | India |
| Pfizer Investigational Site | Jaipur | Rajasthan | 302017 | India |
| Pfizer Investigational Site | Ẕerifin | 70300 | Israel |
| Pfizer Investigational Site | Lido Di Camaiore (LU) | 55043 | Italy |
| Pfizer Investigational Site | Milan | 20133 | Italy |
| Pfizer Investigational Site | Naples | 81013 | Italy |
| Pfizer Investigational Site | Pavia | 27100 | Italy |
| Pfizer Investigational Site | Mexico City | Mexico City | 14080 | Mexico |
| Pfizer Investigational Site | Puebla City | Puebla | 72530 | Mexico |
| Pfizer Investigational Site | Tiel | Gelderland | 4002 WP | Netherlands |
| Pfizer Investigational Site | Groningen | Provincie Groningen | 9713 GZ | Netherlands |
| Pfizer Investigational Site | Amstelveen | 1186 AM | Netherlands |
| Pfizer Investigational Site | The Hague | 2545 CH | Netherlands |
| Pfizer Investigational Site | Otwock | 05-400 | Poland |
| Pfizer Investigational Site | Wodzislaw Sl. | 44-300 | Poland |
| Pfizer Investigational Site | Faro | 8000-386 | Portugal |
| Pfizer Investigational Site | Porto | 4099-001 | Portugal |
| Pfizer Investigational Site | Porto | 4202 | Portugal |
| Pfizer Investigational Site | Vila Nova de Gaia | 4400 | Portugal |
| Pfizer Investigational Site | Parktown | Gauteng | South Africa |
| Pfizer Investigational Site | Cape Town | 7500 | South Africa |
| Pfizer Investigational Site | Cape Town | 7925 | South Africa |
| Pfizer Investigational Site | Johannesburg | 2193 | South Africa |
| Pfizer Investigational Site | Seoul | 110-744 | South Korea |
| Pfizer Investigational Site | Seoul | 120-752 | South Korea |
| Pfizer Investigational Site | Badalona | Barcelona | 08916 | Spain |
| Pfizer Investigational Site | Alcorcón | Madrid | 28922 | Spain |
| Pfizer Investigational Site | Madrid | Madrid | 28041 | Spain |
| Pfizer Investigational Site | Pamplona | Navarre | 31008 | Spain |
| Pfizer Investigational Site | Santa Cruz de Tenerife | Santa Cruz de Tenerife | 38320 | Spain |
| Pfizer Investigational Site | Valencia | Valencia | 46014 | Spain |
| Pfizer Investigational Site | Madrid | 28007 | Spain |
| Pfizer Investigational Site | Stockholm | 118 83 | Sweden |
| Pfizer Investigational Site | Uppsala | 751 85 | Sweden |
| Pfizer Investigational Site | Lausanne | CH-1011 | Switzerland |
| Pfizer Investigational Site | Taipei | 112 | Taiwan |
| Pfizer Investigational Site | Truro | Cornwall | TR1 3LJ | United Kingdom |
| Pfizer Investigational Site | Exeter | Devon | EX2 5DW | United Kingdom |
| Pfizer Investigational Site | London | SE1 9RT | United Kingdom |
| Pfizer Investigational Site | Portsmouth | PO3 6AD | United Kingdom |
| Pfizer Investigational Site | Sheffield | S10 2SJ | United Kingdom |
| Pfizer Investigational Site | Surrey GU2 5XX | United Kingdom |
| Pfizer Investigational Site | Swansea | SA2 8QA | 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 |
|---|---|
| C483020 | ProMune |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| C053518 | CP protocol |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
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