A Study In Patients With Non-Small Cell Lung Cancer To Test If Erlotinib Plus SU011248 Is Better Than Erlotinib Alone

NCT00457392 | Completed Phase 3 Results DMC

• 2 other identifiers: A6181087SUN1087
• Study Type: interventional
• Target: 960
• Locations: 26 countries
• Sites: 204

Brief Summary

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.

Conditions

Carcinoma, Non-Small Cell Lung

Keywords

Non-small cell lung cancer; sunitinib; erlotinib; Phase 3

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Progression-Free Survival (PFS)

  Baseline to disease progression or death due to any cause or 28 days after last dose

• Percentage of Participants With Objective Response (OR)

  Baseline to disease progression or discontinuation from study or 28 days after last dose

• Duration of Response (DR)

  Baseline to disease progression or death or discontinuation from study or 28 days after last dose

• One-year Survival Probability

  Baseline until death or until 28 days after last dose for the last participant

• EuroQol 5-Dimension Questionnaire (EQ-5D)- Health State Profile Utility Score

  Baseline and End of Treatment (EOT) or Withdrawal

Study Arms (2)

1

EXPERIMENTAL

Drug: erlotinib; Drug: sunitinib

2

ACTIVE COMPARATOR

Drug: erlotinib; Drug: placebo

Interventions

erlotinib DRUG

plus erlotinib 150 mg daily by tablets in a continuous regimen until progression or unacceptable toxicity

1

sunitinib DRUG

Sunitinib 37.5 mg daily by oral capsules in a continuous regimen

1

placebo DRUG

Placebo daily by oral capsules in a continuous regimen

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with locally advanced/metastatic non-small cell lung cancer
• Prior treatment with no more than 2 chemotherapy regimens including a platinum-based regimen

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (204)

Pfizer Investigational Site

Florence, Alabama, 35630, United States

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Muscle Shoals, Alabama, 35661, United States

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Scottsdale, Arizona, 85258, United States

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Hot Springs, Arkansas, 71913, United States

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Antioch, California, 94531, United States

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Burbank, California, 91505-4866, United States

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Downey, California, 90241, United States

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Fresno, California, 93720, United States

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La Jolla, California, 92037, United States

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La Jolla, California, 92093-0987, United States

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Montebello, California, 90640, United States

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Pleasant Hill, California, 94523, United States

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San Diego, California, 92103, United States

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San Leandro, California, 94578, United States

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Whittier, California, 90606, United States

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Fairfield, Connecticut, 06824, United States

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Brooksville, Florida, 34613, United States

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Cocoa Beach, Florida, 32931, United States

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Fort Lauderdale, Florida, 33308, United States

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Merritt Island, Florida, 32952, United States

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Rockledge, Florida, 32955, United States

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Titusville, Florida, 32796, United States

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Athens, Georgia, 30607, United States

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Aurora, Illinois, 60504, United States

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Goshen, Indiana, 46526, United States

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Indianapolis, Indiana, 46260-2082, United States

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Council Bluffs, Iowa, 51503, United States

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Baton Rouge, Louisiana, 70809, United States

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Lafayette, Louisiana, 70503, United States

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Bethesda, Maryland, 20817, United States

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Ann Arbor, Michigan, 48106, United States

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Troy, Michigan, 48085, United States

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Columbus, Mississippi, 39705, United States

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Corinth, Mississippi, 38834, United States

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Tupelo, Mississippi, 38801, United States

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City of Saint Peters, Missouri, 63376, United States

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St Louis, Missouri, 63110, United States

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Omaha, Nebraska, 68105, United States

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Las Vegas, Nevada, 89102, United States

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Las Vegas, Nevada, 89106, United States

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Jamaica, New York, 11432, United States

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Norman, Oklahoma, 73071, United States

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Oklahoma City, Oklahoma, 73102, United States

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Oklahoma City, Oklahoma, 73109, United States

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Oklahoma City, Oklahoma, 73120, United States

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Tulsa, Oklahoma, 74014, United States

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Tulsa, Oklahoma, 74104, United States

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Tulsa, Oklahoma, 74136, United States

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Lancaster, Pennsylvania, 17605, United States

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Knoxville, Tennessee, 37920, United States

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Beaumont, Texas, 77701, United States

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Dallas, Texas, 75231, United States

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Grapevine, Texas, 76051, United States

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Irving, Texas, 75063, United States

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Bountiful, Utah, 84010, United States

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Layton, Utah, 84041, United States

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Murray, Utah, 84157, United States

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Provo, Utah, 84604, United States

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Salt Lake City, Utah, 84102, United States

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Salt Lake City, Utah, 84106, United States

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Sandy City, Utah, 84094, United States

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West Valley City, Utah, 84102, United States

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Kennewick, Washington, 99336, United States

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Buenos Aires, Buenos Aires F.D., C1094AAD, Argentina

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Buenos Aires, Buenos Aires F.D., C1122AAL, Argentina

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Córdoba, Córdoba Province, 5000, Argentina

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Buenos Aires, C1034ACO, Argentina

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Grimmenstein, A-2840, Austria

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Innsbruck, A-6020, Austria

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Linz, A-4010, Austria

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Brussels, 1070, Belgium

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Leuven, 3000, Belgium

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Liège, 4000, Belgium

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Rio de Janeiro, Rio de Janeiro, 20230-130, Brazil

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Rio de Janeiro, Rio de Janeiro, 20231 -050, Brazil

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Porto Alegre, Rio Grande do Sul, 90840-440, Brazil

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Barretos, São Paulo, 14784-400, Brazil

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São Paulo, São Paulo, 01308-050, Brazil

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Kingston, Ontario, K7L 2V7, Canada

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Kingston, Ontario, K7L 5P9, Canada

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Oshawa, Ontario, L1G 2B9, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Toronto, Ontario, M5G 2M9, Canada

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Greenfield Park, Quebec, J4V 2H1, Canada

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Lévis, Quebec, G6V 3Z1, Canada

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Québec, Quebec, G1J 1Z4, Canada

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Rimouski, Quebec, G5L 5T1, Canada

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Saskatoon, Saskatchewan, S7N 4H4, Canada

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Santiago, Chile, Chile

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Independencia, Santiago, RM, 8380456, Chile

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Providencia, Santiago, RM, 7500921, Chile

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Medellín, Antioquia, 0, Colombia

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Medellín, Antioquia, Colombia

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České Budějovice, 370 87, Czechia

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Nová Ves pod Pleší, 262 04, Czechia

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Olomouc, 775 20, Czechia

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Ostrava-Poruba, 708 52, Czechia

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Prague, 128 08, Czechia

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Prague, 180 81, Czechia

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Pribram V, 261 95, Czechia

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Tábor, 390 03, Czechia

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Ústí nad Labem, 401 13, Czechia

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Herlev, 2730, Denmark

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Hilleroed, 3400, Denmark

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Koebenhavn OE, 2100, Denmark

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Odense, 5000, Denmark

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Bad Berka, 99437, Germany

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Berlin, 12203, Germany

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Dresden, 01307, Germany

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Ebensfeld, 96250, Germany

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Essen, 45122, Germany

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Gauting, 82131, Germany

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Großhansdorf, 22927, Germany

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Halle, 06120, Germany

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Heidelberg, 69126, Germany

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Homburg, 66424, Germany

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Mainz, 55131, Germany

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Tübingen, 72076, Germany

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Wiesbaden, 65199, Germany

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Heraklion, Crete, 71 110, Greece

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Alexandroupoli, 68100, Greece

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Athens, 11527, Greece

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Kifisia, Athens, 145 64, Greece

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Kowloon, Hong Kong

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Shatin, NT, Hong Kong

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Tuenmen, Hong Kong

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Budapest, H-1529, Hungary

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Deszk, 6772, Hungary

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Gyula, 5703, Hungary

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Mátraháza, H-3233, Hungary

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Székesfehérvár, 8000, Hungary

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Zalaegerszeg-Pozva, H-8900, Hungary

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Catania, 95122, Italy

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Grosseto, 58100, Italy

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Mantova, 46100, Italy

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Milan, 20132, Italy

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Milan, 20162, Italy

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Monza (MI), 20052, Italy

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Novara, 28100, Italy

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Orbassano (TO), 10043, Italy

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Parma, 43100, Italy

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Roma, 00152, Italy

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Rozzano (MI), 20089, Italy

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Enschede, Overijssel, 7513 ER, Netherlands

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's-Hertogenbosch, 5211 RW, Netherlands

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Amsterdam, 1081 HV, Netherlands

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Arnhem, 6815 AD, Netherlands

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Harderwijk, 3844 DG, Netherlands

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Maastricht, 6229 HX, Netherlands

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Rotterdam, 3075 EA, Netherlands

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Rotterdam, 3097 DZ, Netherlands

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Kristiansand, 4604, Norway

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Oslo, 0379, Norway

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Stavanger, 4011, Norway

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Tromsø, 9038, Norway

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Trondheim, 7030, Norway

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Lodz, 93-509, Poland

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Opole, 45-060, Poland

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Otwock, 05-400, Poland

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Warsaw, 01-138, Poland

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Warsaw, 02-781, Poland

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Zielona Góra, 65-046, Poland

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Moscow, 115478, Russia

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Moscow, 143423, Russia

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Saint Petersburg, 194044, Russia

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Saint Petersburg, 197022, Russia

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Bratislava, 826 06, Slovakia

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Košice, 041 90, Slovakia

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Kvetnica Pri Poprade, 058 87, Slovakia

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Nitra-Zobor, 949 88, Slovakia

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Žilina, 012 07, Slovakia

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Seoul, 120-725, South Korea

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Seoul, 120-752, South Korea

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Seoul, 135-710, South Korea

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Seoul, 138-736, South Korea

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Palma de Mallorca, Balearic Islands, 07198, Spain

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Barcelona, Barcelona, 08036, Spain

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Sabadell, Barcelona, 08208, Spain

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A Coruña, La Coruña, 15006, Spain

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Madrid, Madrid, 28046, Spain

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Málaga, Malaga, 29010, Spain

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San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38320, Spain

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Dos Hermanas, Sevilla, 41700, Spain

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Seville, Sevilla, 41013, Spain

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Valencia, Valencia, 46015, Spain

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Genolier, 1272, Switzerland

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Gwei Shan Township, Taoyuan County, 333, Taiwan

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Taichung, 40705, Taiwan

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Tainan, 704, Taiwan

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Pathumwan, Bangkok, 10330, Thailand

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Amphoe Mueang, Chiang Mai, 50200, Thailand

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Bangkok, 10700, Thailand

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Bebington, Wirral, CH63 4JY, United Kingdom

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Cambridge, CB2 0QQ, United Kingdom

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Derby, DE1 2QY, United Kingdom

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Dundee, DD1 9SY, United Kingdom

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Keighley, West Yorkshire, BD20 6TD, United Kingdom

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London, NW1 2PG, United Kingdom

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London, NW3 2QG, United Kingdom

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Peterborough, PE3 6DA, United Kingdom

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Rhyl, Denbigshire, LL18 5UJ, United Kingdom

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Sheffield, S10 2SJ, United Kingdom

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Southampton, SO16 6YD, United Kingdom

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Yeovil, Somerset, BA21 4AT, United Kingdom

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Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride; Sunitinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Indoles

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2007
• First Posted: April 6, 2007
• Study Start: July 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: December 1, 2012
• Last Updated: October 29, 2013
• Results First Posted: August 2, 2011

Record last verified: 2013-09

Locations

IT (11); DE (13); HK (3); GB (12); CZ (9); US (63); ES (10); KR (4); HU (6); SL (5); TH (3); AU (3); CA (10); CO (2); BE (3); NO (5); AR (4); RU (4); CL (3); PL (6); CH (1); TW (3); NL (8); GR (4); DK (4); BR (5)