Not provided
Not provided
Not provided
Not provided
Not provided
See Termination Reason in Detailed Description
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To assess the efficacy and safety of PF-3512676 administered in combination with gemcitabine/cisplatin 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 gemcitabine/cisplatin alone.
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 (thrombocytopenia) also contributing to the decision. Subjects were allowed to complete standard of care treatment/survival follow-up. Data collection was completed on 25 June 2008.
Not provided
Not provided
Not provided
Not provided
| 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 |
|---|---|---|---|---|
| Cisplatin | Drug | Cisplatin 75 mg/m2 intravenously on day 1 of each 21 day cycle x 6 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 656 Events |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported Outcomes | End of treatment | |
| Overall Safety Profile | 28 days post PF03512676 dosing | |
| Progression Free Survival |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Birmingham | Alabama | 35233 | 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Gemcitabine | Drug | Gemcitabine 1250 mg/m2 intravenously on days 1 and 8 of each 21 cycle x 6 cycles |
|
|
| PF-3512676 | Drug | PF-3512676 0.2 mg/kg subcutaneously days 8 and 15 x 6 cycles and then weekly until disease progression or unacceptable toxicity |
|
| Cisplatin | Drug | Cisplatin 75 mg/m2 intravenously on day 1 of each 21 day cycle x 6 cycles |
|
|
| Gemcitabine + Cisplatin | Drug | Gemcitabine 1250 mg/m2 intravenously on days 1 and 8 of each 21 cycle x 6 cycles |
|
|
| Time of primary endpoint |
| Time to Tumor Progression | Time of progressive disease |
| Overall Objective Response | End of treatment |
| Duration of Response | Time of progressive disease |
| Birmingham |
| Alabama |
| 35294 |
| United States |
| Pfizer Investigational Site | Bakersfield | California | 93309 | United States |
| Pfizer Investigational Site | Saint Joseph | Michigan | 49085 | United States |
| Pfizer Investigational Site | Minneapolis | Minnesota | 55455 | United States |
| Pfizer Investigational Site | St Louis | Missouri | 63110 | United States |
| Pfizer Investigational Site | St Louis | Missouri | 63122 | United States |
| Pfizer Investigational Site | New York | New York | 10032 | United States |
| Pfizer Investigational Site | Spokane | Washington | 99202 | United States |
| Pfizer Investigational Site | Spokane | Washington | 99204 | United States |
| Pfizer Investigational Site | Innsbruck | A-6020 | Austria |
| Pfizer Investigational Site | Brussels | 1070 | Belgium |
| Pfizer Investigational Site | Brussels | 1200 | Belgium |
| Pfizer Investigational Site | Charleroi | 6000 | Belgium |
| Pfizer Investigational Site | Hasselt | 3500 | Belgium |
| Pfizer Investigational Site | Jette | 1090 | Belgium |
| Pfizer Investigational Site | Leuven | 3000 | Belgium |
| Pfizer Investigational Site | Liège | 4000 | Belgium |
| Pfizer Investigational Site | Rio de Janeiro | Rio de Janeiro | 20230-130 | Brazil |
| Pfizer Investigational Site | Rio de Janeiro | Rio de Janeiro | 20231 -050 | Brazil |
| Pfizer Investigational Site | Jaú | São Paulo | 17210-080 | Brazil |
| Pfizer Investigational Site | Jaú | São Paulo | 17210-120 | Brazil |
| Pfizer Investigational Site | São Paulo | São Paulo | 01219-000 | Brazil |
| Pfizer Investigational Site | São Paulo | São Paulo | 01221-020 | Brazil |
| Pfizer Investigational Site | São Paulo | São Paulo | 01224-010 | Brazil |
| Pfizer Investigational Site | Toronto | Ontario | M5G 2M9 | Canada |
| Pfizer Investigational Site | Windsor | Ontario | N8W 1L9 | Canada |
| Pfizer Investigational Site | Windsor | Ontario | N8W 2X3 | Canada |
| Pfizer Investigational Site | Greenfield Park | Quebec | J4V 2H1 | Canada |
| Pfizer Investigational Site | Laval | Quebec | H7M 3L9 | Canada |
| Pfizer Investigational Site | Lévis | Quebec | G6V 3Z1 | Canada |
| Pfizer Investigational Site | Québec | Quebec | G1V 4G5 | Canada |
| Pfizer Investigational Site | Guangzhou | Guangdong | 510060 | China |
| Pfizer Investigational Site | Nanjing | Jiangsu | 210002 | China |
| Pfizer Investigational Site | Dalian | Liaoning | 116023 | China |
| Pfizer Investigational Site | Beijing | 100036 | China |
| Pfizer Investigational Site | Beijing | 101149 | China |
| Pfizer Investigational Site | Prague | CZ | 150 06 | Czechia |
| Pfizer Investigational Site | Olomouc | 775 20 | Czechia |
| Pfizer Investigational Site | Prague | 180 81 | Czechia |
| Pfizer Investigational Site | Bielefeld | 33611 | Germany |
| Pfizer Investigational Site | Karlsruhe | 76137 | Germany |
| Pfizer Investigational Site | Löwenstein | 74245 | Germany |
| Pfizer Investigational Site | Mannheim | 68167 | Germany |
| Pfizer Investigational Site | München | 81675 | Germany |
| Pfizer Investigational Site | Tübingen | 72076 | Germany |
| Pfizer Investigational Site | Kowloon | Hong Kong |
| Pfizer Investigational Site | Shatin | Hong Kong |
| Pfizer Investigational Site | Zalaegerszeg | Külsőkórház-Pózva | H-8900 | Hungary |
| Pfizer Investigational Site | Budapest | 1529 | Hungary |
| Pfizer Investigational Site | Deszk | 6772 | Hungary |
| Pfizer Investigational Site | Gyula | 5703 | Hungary |
| Pfizer Investigational Site | Pécs | 7635 | Hungary |
| Pfizer Investigational Site | Bangalore | Karnataka | 560027 | India |
| Pfizer Investigational Site | Kochi | Kerala | 682 304 | India |
| Pfizer Investigational Site | Pune | Maharashtra | 411 004 | India |
| Pfizer Investigational Site | New Delhi | New Delhi | 110085 | India |
| Pfizer Investigational Site | Ludhiana | Punjab | 141001 | India |
| Pfizer Investigational Site | Lucknow | Uttar Pradesh | 226003 | India |
| Pfizer Investigational Site | Beersheba | 84101 | Israel |
| Pfizer Investigational Site | Kfar Saba | 44281 | Israel |
| Pfizer Investigational Site | Forlì | 47100 | Italy |
| Pfizer Investigational Site | Milan | 20100 | Italy |
| Pfizer Investigational Site | Pisa | 56127 | Italy |
| Pfizer Investigational Site | Roma | 00144 | Italy |
| Pfizer Investigational Site | S.Andrea Delle Fratte (PG) | 06132 | Italy |
| Pfizer Investigational Site | Amsterdam | North Holland | 1066 CX | Netherlands |
| Pfizer Investigational Site | Zaandam | North Holland | 1502 DV | Netherlands |
| Pfizer Investigational Site | 's-Hertogenbosch | 5211 RW | Netherlands |
| Pfizer Investigational Site | Harderwijk | 3844 DG | Netherlands |
| Pfizer Investigational Site | Nijmegen | 6525 GA | Netherlands |
| Pfizer Investigational Site | Gdansk | 80-952 | Poland |
| Pfizer Investigational Site | Lodz | 93-509 | Poland |
| Pfizer Investigational Site | Otwock | 05-400 | Poland |
| Pfizer Investigational Site | Szczecin-Zdunowo | 70-891 | Poland |
| Pfizer Investigational Site | Warsaw | 00-909 | Poland |
| Pfizer Investigational Site | Warsaw | 01-138 | Poland |
| Pfizer Investigational Site | Warsaw | 02-781 | Poland |
| Pfizer Investigational Site | Wodzislaw Sl. | 44-300 | Poland |
| Pfizer Investigational Site | Coimbra | 3041-801 | Portugal |
| Pfizer Investigational Site | Lisbon | 1099-023 | Portugal |
| Pfizer Investigational Site | Lisbon | 1649-035 | Portugal |
| Pfizer Investigational Site | Lisbon | 1769-001 | Portugal |
| Pfizer Investigational Site | Porto | 4200-072 | Portugal |
| Pfizer Investigational Site | Singapore | Singapore | 169610 | Singapore |
| Pfizer Investigational Site | Bratislava | 82606 | Slovakia |
| Pfizer Investigational Site | Košice | 041 91 | Slovakia |
| Pfizer Investigational Site | Kvetnica Pri Poprade | 058 07 | Slovakia |
| Pfizer Investigational Site | Nitra-Zobor | 949 88 | Slovakia |
| Pfizer Investigational Site | Port Elizabeth | Eastern Cape | 6001 | South Africa |
| Pfizer Investigational Site | Cape Town | 7405 | South Africa |
| Pfizer Investigational Site | Port Elizabeth | 6001 | South Africa |
| Pfizer Investigational Site | Gyeonggi-do | 410-769 | South Korea |
| Pfizer Investigational Site | Seoul | 135-710 | South Korea |
| Pfizer Investigational Site | Seoul | 137-701 | South Korea |
| Pfizer Investigational Site | Seoul | 138-736 | South Korea |
| Pfizer Investigational Site | Alicante | Alicante | 03010 | Spain |
| Pfizer Investigational Site | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Pfizer Investigational Site | Santander | Cantabria | 39008 | Spain |
| Pfizer Investigational Site | Castellon | Castellon | 12002 | Spain |
| Pfizer Investigational Site | Girona | Gerona | 17007 | Spain |
| Pfizer Investigational Site | Jaén | Jaen | 23007 | Spain |
| Pfizer Investigational Site | Barakaldo | Vizcaya | 48903 | Spain |
| Pfizer Investigational Site | Taichung | Taiwan |
| Pfizer Investigational Site | Tainan | 704 | Taiwan |
| Pfizer Investigational Site | Taipei | 100 | Taiwan |
| Pfizer Investigational Site | Taipei | 112 | Taiwan |
| Pfizer Investigational Site | Ankara | 06100 | Turkey (Türkiye) |
| Pfizer Investigational Site | Bornova / Izmir | 35050 | Turkey (Türkiye) |
| Pfizer Investigational Site | Istanbul / Ceraahpasa | 34303 | Turkey (Türkiye) |
| Pfizer Investigational Site | Bristol | Avon | BS2 8ED | United Kingdom |
| Pfizer Investigational Site | Southampton | Hampshire | SO16 6YD | United Kingdom |
| Pfizer Investigational Site | Sutton | Surrey | SM2 5PT | United Kingdom |
| Pfizer Investigational Site | Belfast | BT9 7AB | United Kingdom |
| Pfizer Investigational Site | Dundee | DD1 9SY | United Kingdom |
| Pfizer Investigational Site | Edinburgh | EH4 2XU | United Kingdom |
| Pfizer Investigational Site | Glasgow | G12 0YN | United Kingdom |
| Pfizer Investigational Site | Leicester | LE1 5WW | United Kingdom |
| Pfizer Investigational Site | London | NW3 2Qg | United Kingdom |
| Pfizer Investigational Site | Wolverhampton | WV10 0QP | 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D000093542 | Gemcitabine |
| C483020 | ProMune |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided