Carcinoma, Non-Small Cell Lung Clinical Trial
Official title:
A Multicenter, Randomized, Double-Blind, Controlled Phase 3, Efficacy And Safety Study Of Sunitinib (SU011248) In Patients With Advanced/Metastatic Non-Small Cell Lung Cancer Treated With Erlotinib
| Verified date | September 2013 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This study will test whether treatment with erlotinib plus SU011248 is better than erlotinib alone in patients with advanced/metastatic lung cancer who have received previous treatment with a platinum-based regimen.
| Status | Completed |
| Enrollment | 960 |
| Est. completion date | December 2012 |
| Est. primary completion date | July 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients with locally advanced/metastatic non-small cell lung cancer - Prior treatment with no more than 2 chemotherapy regimens including a platinum-based regimen Exclusion Criteria: - Prior treatment with any receptor tyrosine kinase inhibitors, VEGF inhibitor (with the exception of bevacizumab) or other angiogenesis inhibitors - History of or known brain metastases |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Pfizer Investigational Site | Buenos Aires | |
| Argentina | Pfizer Investigational Site | Buenos Aires | Capital Federal |
| Argentina | Pfizer Investigational Site | Ciudad Autonoma de Buenos Aires | Capital Federal |
| Argentina | Pfizer Investigational Site | Cordoba | |
| Austria | Pfizer Investigational Site | Grimmenstein | |
| Austria | Pfizer Investigational Site | Innsbruck | |
| Austria | Pfizer Investigational Site | Linz | |
| Belgium | Pfizer Investigational Site | Bruxelles | |
| Belgium | Pfizer Investigational Site | Leuven | |
| Belgium | Pfizer Investigational Site | Liege | |
| Brazil | Pfizer Investigational Site | Barretos | SP |
| Brazil | Pfizer Investigational Site | Porto Alegre | RS |
| Brazil | Pfizer Investigational Site | Rio de Janeiro | RJ |
| Brazil | Pfizer Investigational Site | Rio de Janeiro | RJ |
| Brazil | Pfizer Investigational Site | Sao Paulo | SP |
| Canada | Pfizer Investigational Site | Greenfield Park | Quebec |
| Canada | Pfizer Investigational Site | Kingston | Ontario |
| Canada | Pfizer Investigational Site | Kingston | Ontario |
| Canada | Pfizer Investigational Site | Levis | Quebec |
| Canada | Pfizer Investigational Site | Oshawa | Ontario |
| Canada | Pfizer Investigational Site | Quebec | |
| Canada | Pfizer Investigational Site | Rimouski | Quebec |
| Canada | Pfizer Investigational Site | Saskatoon | Saskatchewan |
| Canada | Pfizer Investigational Site | Toronto | Ontario |
| Canada | Pfizer Investigational Site | Toronto | Ontario |
| Chile | Pfizer Investigational Site | Independencia | Santiago, RM |
| Chile | Pfizer Investigational Site | Providencia | Santiago, RM |
| Chile | Pfizer Investigational Site | Santiago | |
| Colombia | Pfizer Investigational Site | Medellin | Antioquia |
| Colombia | Pfizer Investigational Site | Medellin | Antioquia |
| Czech Republic | Pfizer Investigational Site | Ceske Budejovice | |
| Czech Republic | Pfizer Investigational Site | Nova Ves pod Plesi | |
| Czech Republic | Pfizer Investigational Site | Olomouc | |
| Czech Republic | Pfizer Investigational Site | Ostrava-Poruba | |
| Czech Republic | Pfizer Investigational Site | Praha 2 | |
| Czech Republic | Pfizer Investigational Site | Praha 8 | |
| Czech Republic | Pfizer Investigational Site | Pribram V | |
| Czech Republic | Pfizer Investigational Site | Tabor | |
| Czech Republic | Pfizer Investigational Site | Usti nad Labem | |
| Denmark | Pfizer Investigational Site | Herlev | |
| Denmark | Pfizer Investigational Site | Hilleroed | |
| Denmark | Pfizer Investigational Site | Koebenhavn OE | |
| Denmark | Pfizer Investigational Site | Odense | |
| Germany | Pfizer Investigational Site | Bad Berka | |
| Germany | Pfizer Investigational Site | Berlin | |
| Germany | Pfizer Investigational Site | Dresden | |
| Germany | Pfizer Investigational Site | Ebensfeld | |
| Germany | Pfizer Investigational Site | Essen | |
| Germany | Pfizer Investigational Site | Gauting | |
| Germany | Pfizer Investigational Site | Grosshansdorf | |
| Germany | Pfizer Investigational Site | Halle (Saale) | |
| Germany | Pfizer Investigational Site | Heidelberg | |
| Germany | Pfizer Investigational Site | Homburg | |
| Germany | Pfizer Investigational Site | Mainz | |
| Germany | Pfizer Investigational Site | Tuebingen | |
| Germany | Pfizer Investigational Site | Wiesbaden | |
| Greece | Pfizer Investigational Site | Alexandroupoli | |
| Greece | Pfizer Investigational Site | Athens | |
| Greece | Pfizer Investigational Site | Heraklion | Crete |
| Greece | Pfizer Investigational Site | Kifisia, Athens | |
| Hong Kong | Pfizer Investigational Site | Kowloon | |
| Hong Kong | Pfizer Investigational Site | Shatin, NT | |
| Hong Kong | Pfizer Investigational Site | Tuen Mun, | |
| Hungary | Pfizer Investigational Site | Budapest | |
| Hungary | Pfizer Investigational Site | Deszk | |
| Hungary | Pfizer Investigational Site | Gyula | |
| Hungary | Pfizer Investigational Site | Matrahaza | |
| Hungary | Pfizer Investigational Site | Szekesfehervar | |
| Hungary | Pfizer Investigational Site | Zalaegerszeg-Pozva | |
| Italy | Pfizer Investigational Site | Catania | |
| Italy | Pfizer Investigational Site | Grosseto | |
| Italy | Pfizer Investigational Site | Mantova | |
| Italy | Pfizer Investigational Site | Milano | |
| Italy | Pfizer Investigational Site | Milano | |
| Italy | Pfizer Investigational Site | Monza (MI) | |
| Italy | Pfizer Investigational Site | Novara | |
| Italy | Pfizer Investigational Site | Orbassano (TO) | |
| Italy | Pfizer Investigational Site | Parma | |
| Italy | Pfizer Investigational Site | Roma | |
| Italy | Pfizer Investigational Site | Rozzano (MI) | |
| Korea, Republic of | Pfizer Investigational Site | Seoul | |
| Korea, Republic of | Pfizer Investigational Site | Seoul | |
| Korea, Republic of | Pfizer Investigational Site | Seoul | |
| Korea, Republic of | Pfizer Investigational Site | Seoul | |
| Netherlands | Pfizer Investigational Site | 's-Hertogenbosch | |
| Netherlands | Pfizer Investigational Site | Amsterdam | |
| Netherlands | Pfizer Investigational Site | Arnhem | |
| Netherlands | Pfizer Investigational Site | Enschede | Ov |
| Netherlands | Pfizer Investigational Site | Harderwijk | |
| Netherlands | Pfizer Investigational Site | Maastricht | |
| Netherlands | Pfizer Investigational Site | Rotterdam | |
| Netherlands | Pfizer Investigational Site | Rotterdam | |
| Norway | Pfizer Investigational Site | Kristiansand S | |
| Norway | Pfizer Investigational Site | Oslo | |
| Norway | Pfizer Investigational Site | Stavanger | |
| Norway | Pfizer Investigational Site | Tromso | |
| Norway | Pfizer Investigational Site | Trondheim | |
| Poland | Pfizer Investigational Site | Lodz | |
| Poland | Pfizer Investigational Site | Opole | |
| Poland | Pfizer Investigational Site | Otwock | |
| Poland | Pfizer Investigational Site | Warszawa | |
| Poland | Pfizer Investigational Site | Warszawa | |
| Poland | Pfizer Investigational Site | Zielona Gora | |
| Russian Federation | Pfizer Investigational Site | Moscow | |
| Russian Federation | Pfizer Investigational Site | Moscow | |
| Russian Federation | Pfizer Investigational Site | St-Petersburg | |
| Russian Federation | Pfizer Investigational Site | St. Petersburg | |
| Slovakia | Pfizer Investigational Site | Bratislava | |
| Slovakia | Pfizer Investigational Site | Kosice | |
| Slovakia | Pfizer Investigational Site | Kvetnica pri Poprade | |
| Slovakia | Pfizer Investigational Site | Nitra-Zobor | |
| Slovakia | Pfizer Investigational Site | Zilina | |
| Spain | Pfizer Investigational Site | Barcelona | |
| Spain | Pfizer Investigational Site | Dos Hermanas | Sevilla |
| Spain | Pfizer Investigational Site | La Coruña | |
| Spain | Pfizer Investigational Site | La Laguna | Santa Cruz de Tenerife |
| Spain | Pfizer Investigational Site | Madrid | |
| Spain | Pfizer Investigational Site | Malaga | |
| Spain | Pfizer Investigational Site | Palma de Mallorca | Islas Baleares |
| Spain | Pfizer Investigational Site | Sabadell | Barcelona |
| Spain | Pfizer Investigational Site | Sevilla | |
| Spain | Pfizer Investigational Site | Valencia | |
| Switzerland | Pfizer Investigational Site | Genolier | |
| Taiwan | Pfizer Investigational Site | Gwei Shan Township | Taoyuan County |
| Taiwan | Pfizer Investigational Site | Taichung | |
| Taiwan | Pfizer Investigational Site | Tainan | |
| Thailand | Pfizer Investigational Site | Amphoe Mueang | Chiang Mai |
| Thailand | Pfizer Investigational Site | Bangkok | |
| Thailand | Pfizer Investigational Site | Pathumwan | Bangkok |
| United Kingdom | Pfizer Investigational Site | Bebington, Wirral | |
| United Kingdom | Pfizer Investigational Site | Cambridge | |
| United Kingdom | Pfizer Investigational Site | Derby | |
| United Kingdom | Pfizer Investigational Site | Dundee | |
| United Kingdom | Pfizer Investigational Site | Keighley, West Yorkshire | |
| United Kingdom | Pfizer Investigational Site | London | |
| United Kingdom | Pfizer Investigational Site | London | |
| United Kingdom | Pfizer Investigational Site | Peterborough | |
| United Kingdom | Pfizer Investigational Site | Rhyl, Denbigshire | |
| United Kingdom | Pfizer Investigational Site | Sheffield | |
| United Kingdom | Pfizer Investigational Site | Southampton | |
| United Kingdom | Pfizer Investigational Site | Yeovil, Somerset | |
| United States | Pfizer Investigational Site | Ann Arbor | Michigan |
| United States | Pfizer Investigational Site | Antioch | California |
| United States | Pfizer Investigational Site | Athens | Georgia |
| United States | Pfizer Investigational Site | Aurora | Illinois |
| United States | Pfizer Investigational Site | Baton Rouge | Louisiana |
| United States | Pfizer Investigational Site | Beaumont | Texas |
| United States | Pfizer Investigational Site | Bethesda | Maryland |
| United States | Pfizer Investigational Site | Bountiful | Utah |
| United States | Pfizer Investigational Site | Brooksville | Florida |
| United States | Pfizer Investigational Site | Burbank | California |
| United States | Pfizer Investigational Site | Cocoa Beach | Florida |
| United States | Pfizer Investigational Site | Columbus | Mississippi |
| United States | Pfizer Investigational Site | Corinth | Mississippi |
| United States | Pfizer Investigational Site | Council Bluffs | Iowa |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | Downey | California |
| United States | Pfizer Investigational Site | Fairfield | Connecticut |
| United States | Pfizer Investigational Site | Florence | Alabama |
| United States | Pfizer Investigational Site | Fort Lauderdale | Florida |
| United States | Pfizer Investigational Site | Fresno | California |
| United States | Pfizer Investigational Site | Goshen | Indiana |
| United States | Pfizer Investigational Site | Grapevine | Texas |
| United States | Pfizer Investigational Site | Hot Springs | Arkansas |
| United States | Pfizer Investigational Site | Indianapolis | Indiana |
| United States | Pfizer Investigational Site | Irving | Texas |
| United States | Pfizer Investigational Site | Jamaica | New York |
| United States | Pfizer Investigational Site | Kennewick | Washington |
| United States | Pfizer Investigational Site | Knoxville | Tennessee |
| United States | Pfizer Investigational Site | La Jolla | California |
| United States | Pfizer Investigational Site | La Jolla | California |
| United States | Pfizer Investigational Site | Lafayette | Louisiana |
| United States | Pfizer Investigational Site | Lancaster | Pennsylvania |
| United States | Pfizer Investigational Site | Las Vegas | Nevada |
| United States | Pfizer Investigational Site | Las Vegas | Nevada |
| United States | Pfizer Investigational Site | Layton | Utah |
| United States | Pfizer Investigational Site | Merritt Island | Florida |
| United States | Pfizer Investigational Site | Montebello | California |
| United States | Pfizer Investigational Site | Murray | Utah |
| United States | Pfizer Investigational Site | Muscle Shoals | Alabama |
| United States | Pfizer Investigational Site | Norman | Oklahoma |
| United States | Pfizer Investigational Site | Oklahoma City | Oklahoma |
| United States | Pfizer Investigational Site | Oklahoma City | Oklahoma |
| United States | Pfizer Investigational Site | Oklahoma City | Oklahoma |
| United States | Pfizer Investigational Site | Omaha | Nebraska |
| United States | Pfizer Investigational Site | Pleasant Hill | California |
| United States | Pfizer Investigational Site | Provo | Utah |
| United States | Pfizer Investigational Site | Rockledge | Florida |
| United States | Pfizer Investigational Site | Salt Lake City | Utah |
| United States | Pfizer Investigational Site | Salt Lake City | Utah |
| United States | Pfizer Investigational Site | San Diego | California |
| United States | Pfizer Investigational Site | San Leandro | California |
| United States | Pfizer Investigational Site | Sandy | Utah |
| United States | Pfizer Investigational Site | Scottsdale | Arizona |
| United States | Pfizer Investigational Site | St. Louis | Missouri |
| United States | Pfizer Investigational Site | St. Peters | Missouri |
| United States | Pfizer Investigational Site | Titusville | Florida |
| United States | Pfizer Investigational Site | Troy | Michigan |
| United States | Pfizer Investigational Site | Tulsa | Oklahoma |
| United States | Pfizer Investigational Site | Tulsa | Oklahoma |
| United States | Pfizer Investigational Site | Tulsa | Oklahoma |
| United States | Pfizer Investigational Site | Tupelo | Mississippi |
| United States | Pfizer Investigational Site | West Valley | Utah |
| United States | Pfizer Investigational Site | Whittier | California |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Argentina, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Germany, Greece, Hong Kong, Hungary, Italy, Korea, Republic of, Netherlands, Norway, Poland, Russian Federation, Slovakia, Spain, Switzerland, Taiwan, Thailand, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall Survival (OS) | Overall survival is the duration from assignment to study medication to death. For participants who are alive, overall survival is censored at the last contact. | Baseline to death or 28 days after last dose for the last participant | No |
| Secondary | Progression-Free Survival (PFS) | Time in weeks from assignment to study medication to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death"). | Baseline to disease progression or death due to any cause or 28 days after last dose | No |
| Secondary | Percentage of Participants With Objective Response (OR) | Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as disappearance of all lesions (target and/or non target). PR are those with at least 30% decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent. | Baseline to disease progression or discontinuation from study or 28 days after last dose | No |
| Secondary | Duration of Response (DR) | Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. | Baseline to disease progression or death or discontinuation from study or 28 days after last dose | No |
| Secondary | One-year Survival Probability | The 1 year survival probability was defined as the probability of survival at one year after the date of the start of the study treatment based on the Kaplan Meier estimate. | Baseline until death or until 28 days after last dose for the last participant | No |
| Secondary | EuroQol 5-Dimension Questionnaire (EQ-5D)- Health State Profile Utility Score | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates better health state. | Baseline and End of Treatment (EOT) or Withdrawal | No |
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