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

September 24, 2013 updated by: Pfizer

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

960

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Buenos Aires, Argentina, C1034ACO
        • Pfizer Investigational Site
      • Cordoba, Argentina, 5000
        • Pfizer Investigational Site
    • Capital Federal
      • Buenos Aires, Capital Federal, Argentina, C1122AAL
        • Pfizer Investigational Site
      • Ciudad Autonoma de Buenos Aires, Capital Federal, Argentina, C1094AAD
        • Pfizer Investigational Site
      • Grimmenstein, Austria, A-2840
        • Pfizer Investigational Site
      • Innsbruck, Austria, A-6020
        • Pfizer Investigational Site
      • Linz, Austria, A-4010
        • Pfizer Investigational Site
      • Bruxelles, Belgium, 1070
        • Pfizer Investigational Site
      • Leuven, Belgium, 3000
        • Pfizer Investigational Site
      • Liege, Belgium, 4000
        • Pfizer Investigational Site
    • RJ
      • Rio de Janeiro, RJ, Brazil, 20230-130
        • Pfizer Investigational Site
      • Rio de Janeiro, RJ, Brazil, 20231 -050
        • Pfizer Investigational Site
    • RS
      • Porto Alegre, RS, Brazil, 90840-440
        • Pfizer Investigational Site
    • SP
      • Barretos, SP, Brazil, 14784-400
        • Pfizer Investigational Site
      • Sao Paulo, SP, Brazil, 01308-050
        • Pfizer Investigational Site
      • Quebec, Canada, G1J 1Z4
        • Pfizer Investigational Site
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Pfizer Investigational Site
      • Kingston, Ontario, Canada, K7L 5P9
        • Pfizer Investigational Site
      • Oshawa, Ontario, Canada, L1G 2B9
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M4N 3M5
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M5G 2M9
        • Pfizer Investigational Site
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Pfizer Investigational Site
      • Levis, Quebec, Canada, G6V 3Z1
        • Pfizer Investigational Site
      • Rimouski, Quebec, Canada, G5L 5T1
        • Pfizer Investigational Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Pfizer Investigational Site
      • Santiago, Chile
        • Pfizer Investigational Site
    • Santiago, RM
      • Independencia, Santiago, RM, Chile, 8380456
        • Pfizer Investigational Site
      • Providencia, Santiago, RM, Chile, 7500921
        • Pfizer Investigational Site
    • Antioquia
      • Medellin, Antioquia, Colombia
        • Pfizer Investigational Site
      • Medellin, Antioquia, Colombia
        • Pfizer Investigational Site
      • Ceske Budejovice, Czech Republic, 370 87
        • Pfizer Investigational Site
      • Nova Ves pod Plesi, Czech Republic, 262 04
        • Pfizer Investigational Site
      • Olomouc, Czech Republic, 775 20
        • Pfizer Investigational Site
      • Ostrava-Poruba, Czech Republic, 708 52
        • Pfizer Investigational Site
      • Praha 2, Czech Republic, 128 08
        • Pfizer Investigational Site
      • Praha 8, Czech Republic, 180 81
        • Pfizer Investigational Site
      • Pribram V, Czech Republic, 261 95
        • Pfizer Investigational Site
      • Tabor, Czech Republic, 390 03
        • Pfizer Investigational Site
      • Usti nad Labem, Czech Republic, 401 13
        • Pfizer Investigational Site
      • Herlev, Denmark, 2730
        • Pfizer Investigational Site
      • Hilleroed, Denmark, 3400
        • Pfizer Investigational Site
      • Koebenhavn OE, Denmark, 2100
        • Pfizer Investigational Site
      • Odense, Denmark, 5000
        • Pfizer Investigational Site
      • Bad Berka, Germany, 99437
        • Pfizer Investigational Site
      • Berlin, Germany, 12203
        • Pfizer Investigational Site
      • Dresden, Germany, 01307
        • Pfizer Investigational Site
      • Ebensfeld, Germany, 96250
        • Pfizer Investigational Site
      • Essen, Germany, 45122
        • Pfizer Investigational Site
      • Gauting, Germany, 82131
        • Pfizer Investigational Site
      • Grosshansdorf, Germany, 22927
        • Pfizer Investigational Site
      • Halle (Saale), Germany, 06120
        • Pfizer Investigational Site
      • Heidelberg, Germany, 69126
        • Pfizer Investigational Site
      • Homburg, Germany, 66424
        • Pfizer Investigational Site
      • Mainz, Germany, 55131
        • Pfizer Investigational Site
      • Tuebingen, Germany, 72076
        • Pfizer Investigational Site
      • Wiesbaden, Germany, 65199
        • Pfizer Investigational Site
      • Alexandroupoli, Greece, 68100
        • Pfizer Investigational Site
      • Athens, Greece, 11527
        • Pfizer Investigational Site
      • Kifisia, Athens, Greece, 145 64
        • Pfizer Investigational Site
    • Crete
      • Heraklion, Crete, Greece, 71 110
        • Pfizer Investigational Site
      • Kowloon, Hong Kong
        • Pfizer Investigational Site
      • Shatin, NT, Hong Kong
        • Pfizer Investigational Site
      • Tuen Mun,, Hong Kong
        • Pfizer Investigational Site
      • Budapest, Hungary, H-1529
        • Pfizer Investigational Site
      • Deszk, Hungary, 6772
        • Pfizer Investigational Site
      • Gyula, Hungary, 5703
        • Pfizer Investigational Site
      • Matrahaza, Hungary, H-3233
        • Pfizer Investigational Site
      • Szekesfehervar, Hungary, 8000
        • Pfizer Investigational Site
      • Zalaegerszeg-Pozva, Hungary, H-8900
        • Pfizer Investigational Site
      • Catania, Italy, 95122
        • Pfizer Investigational Site
      • Grosseto, Italy, 58100
        • Pfizer Investigational Site
      • Mantova, Italy, 46100
        • Pfizer Investigational Site
      • Milano, Italy, 20132
        • Pfizer Investigational Site
      • Milano, Italy, 20162
        • Pfizer Investigational Site
      • Monza (MI), Italy, 20052
        • Pfizer Investigational Site
      • Novara, Italy, 28100
        • Pfizer Investigational Site
      • Orbassano (TO), Italy, 10043
        • Pfizer Investigational Site
      • Parma, Italy, 43100
        • Pfizer Investigational Site
      • Roma, Italy, 00152
        • Pfizer Investigational Site
      • Rozzano (MI), Italy, 20089
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 120-752
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 138-736
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 135-710
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 120-725
        • Pfizer Investigational Site
      • 's-Hertogenbosch, Netherlands, 5211 RW
        • Pfizer Investigational Site
      • Amsterdam, Netherlands, 1081 HV
        • Pfizer Investigational Site
      • Arnhem, Netherlands, 6815 AD
        • Pfizer Investigational Site
      • Harderwijk, Netherlands, 3844 DG
        • Pfizer Investigational Site
      • Maastricht, Netherlands, 6229 HX
        • Pfizer Investigational Site
      • Rotterdam, Netherlands, 3075 EA
        • Pfizer Investigational Site
      • Rotterdam, Netherlands, 3097 DZ
        • Pfizer Investigational Site
    • Ov
      • Enschede, Ov, Netherlands, 7513 ER
        • Pfizer Investigational Site
      • Kristiansand S, Norway, 4604
        • Pfizer Investigational Site
      • Oslo, Norway, 0379
        • Pfizer Investigational Site
      • Stavanger, Norway, 4011
        • Pfizer Investigational Site
      • Tromso, Norway, 9038
        • Pfizer Investigational Site
      • Trondheim, Norway, 7030
        • Pfizer Investigational Site
      • Lodz, Poland, 93-509
        • Pfizer Investigational Site
      • Opole, Poland, 45-060
        • Pfizer Investigational Site
      • Otwock, Poland, 05-400
        • Pfizer Investigational Site
      • Warszawa, Poland, 02-781
        • Pfizer Investigational Site
      • Warszawa, Poland, 01-138
        • Pfizer Investigational Site
      • Zielona Gora, Poland, 65-046
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 115478
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 143423
        • Pfizer Investigational Site
      • St-Petersburg, Russian Federation, 194044
        • Pfizer Investigational Site
      • St. Petersburg, Russian Federation, 197022
        • Pfizer Investigational Site
      • Bratislava, Slovakia, 826 06
        • Pfizer Investigational Site
      • Kosice, Slovakia, 041 90
        • Pfizer Investigational Site
      • Kvetnica pri Poprade, Slovakia, 058 87
        • Pfizer Investigational Site
      • Nitra-Zobor, Slovakia, 949 88
        • Pfizer Investigational Site
      • Zilina, Slovakia, 012 07
        • Pfizer Investigational Site
      • Barcelona, Spain, 08036
        • Pfizer Investigational Site
      • La Coruña, Spain, 15006
        • Pfizer Investigational Site
      • Madrid, Spain, 28046
        • Pfizer Investigational Site
      • Malaga, Spain, 29010
        • Pfizer Investigational Site
      • Sevilla, Spain, 41013
        • Pfizer Investigational Site
      • Valencia, Spain, 46015
        • Pfizer Investigational Site
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Pfizer Investigational Site
    • Islas Baleares
      • Palma de Mallorca, Islas Baleares, Spain, 07198
        • Pfizer Investigational Site
    • Santa Cruz de Tenerife
      • La Laguna, Santa Cruz de Tenerife, Spain, 38320
        • Pfizer Investigational Site
    • Sevilla
      • Dos Hermanas, Sevilla, Spain, 41700
        • Pfizer Investigational Site
      • Genolier, Switzerland, 1272
        • Pfizer Investigational Site
      • Taichung, Taiwan, 40705
        • Pfizer Investigational Site
      • Tainan, Taiwan, 704
        • Pfizer Investigational Site
    • Taoyuan County
      • Gwei Shan Township, Taoyuan County, Taiwan, 333
        • Pfizer Investigational Site
      • Bangkok, Thailand, 10700
        • Pfizer Investigational Site
    • Bangkok
      • Pathumwan, Bangkok, Thailand, 10330
        • Pfizer Investigational Site
    • Chiang Mai
      • Amphoe Mueang, Chiang Mai, Thailand, 50200
        • Pfizer Investigational Site
      • Bebington, Wirral, United Kingdom, CH63 4JY
        • Pfizer Investigational Site
      • Cambridge, United Kingdom, CB2 0QQ
        • Pfizer Investigational Site
      • Derby, United Kingdom, DE1 2QY
        • Pfizer Investigational Site
      • Dundee, United Kingdom, DD1 9SY
        • Pfizer Investigational Site
      • Keighley, West Yorkshire, United Kingdom, BD20 6TD
        • Pfizer Investigational Site
      • London, United Kingdom, NW3 2QG
        • Pfizer Investigational Site
      • London, United Kingdom, NW1 2PG
        • Pfizer Investigational Site
      • Peterborough, United Kingdom, PE3 6DA
        • Pfizer Investigational Site
      • Rhyl, Denbigshire, United Kingdom, LL18 5UJ
        • Pfizer Investigational Site
      • Sheffield, United Kingdom, S10 2SJ
        • Pfizer Investigational Site
      • Southampton, United Kingdom, SO16 6YD
        • Pfizer Investigational Site
      • Yeovil, Somerset, United Kingdom, BA21 4AT
        • Pfizer Investigational Site
    • Alabama
      • Florence, Alabama, United States, 35630
        • Pfizer Investigational Site
      • Muscle Shoals, Alabama, United States, 35661
        • Pfizer Investigational Site
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Pfizer Investigational Site
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Pfizer Investigational Site
    • California
      • Antioch, California, United States, 94531
        • Pfizer Investigational Site
      • Burbank, California, United States, 91505-4866
        • Pfizer Investigational Site
      • Downey, California, United States, 90241
        • Pfizer Investigational Site
      • Fresno, California, United States, 93720
        • Pfizer Investigational Site
      • La Jolla, California, United States, 92037
        • Pfizer Investigational Site
      • La Jolla, California, United States, 92093-0987
        • Pfizer Investigational Site
      • Montebello, California, United States, 90640
        • Pfizer Investigational Site
      • Pleasant Hill, California, United States, 94523
        • Pfizer Investigational Site
      • San Diego, California, United States, 92103
        • Pfizer Investigational Site
      • San Leandro, California, United States, 94578
        • Pfizer Investigational Site
      • Whittier, California, United States, 90606
        • Pfizer Investigational Site
    • Connecticut
      • Fairfield, Connecticut, United States, 06824
        • Pfizer Investigational Site
    • Florida
      • Brooksville, Florida, United States, 34613
        • Pfizer Investigational Site
      • Cocoa Beach, Florida, United States, 32931
        • Pfizer Investigational Site
      • Fort Lauderdale, Florida, United States, 33308
        • Pfizer Investigational Site
      • Merritt Island, Florida, United States, 32952
        • Pfizer Investigational Site
      • Rockledge, Florida, United States, 32955
        • Pfizer Investigational Site
      • Titusville, Florida, United States, 32796
        • Pfizer Investigational Site
    • Georgia
      • Athens, Georgia, United States, 30607
        • Pfizer Investigational Site
    • Illinois
      • Aurora, Illinois, United States, 60504
        • Pfizer Investigational Site
    • Indiana
      • Goshen, Indiana, United States, 46526
        • Pfizer Investigational Site
      • Indianapolis, Indiana, United States, 46260-2082
        • Pfizer Investigational Site
    • Iowa
      • Council Bluffs, Iowa, United States, 51503
        • Pfizer Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Pfizer Investigational Site
      • Lafayette, Louisiana, United States, 70503
        • Pfizer Investigational Site
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Pfizer Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Pfizer Investigational Site
      • Troy, Michigan, United States, 48085
        • Pfizer Investigational Site
    • Mississippi
      • Columbus, Mississippi, United States, 39705
        • Pfizer Investigational Site
      • Corinth, Mississippi, United States, 38834
        • Pfizer Investigational Site
      • Tupelo, Mississippi, United States, 38801
        • Pfizer Investigational Site
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Pfizer Investigational Site
      • St. Peters, Missouri, United States, 63376
        • Pfizer Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68105
        • Pfizer Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Pfizer Investigational Site
      • Las Vegas, Nevada, United States, 89106
        • Pfizer Investigational Site
    • New York
      • Jamaica, New York, United States, 11432
        • Pfizer Investigational Site
    • Oklahoma
      • Norman, Oklahoma, United States, 73071
        • Pfizer Investigational Site
      • Oklahoma City, Oklahoma, United States, 73120
        • Pfizer Investigational Site
      • Oklahoma City, Oklahoma, United States, 73102
        • Pfizer Investigational Site
      • Oklahoma City, Oklahoma, United States, 73109
        • Pfizer Investigational Site
      • Tulsa, Oklahoma, United States, 74136
        • Pfizer Investigational Site
      • Tulsa, Oklahoma, United States, 74104
        • Pfizer Investigational Site
      • Tulsa, Oklahoma, United States, 74014
        • Pfizer Investigational Site
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17605
        • Pfizer Investigational Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Pfizer Investigational Site
    • Texas
      • Beaumont, Texas, United States, 77701
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75231
        • Pfizer Investigational Site
      • Grapevine, Texas, United States, 76051
        • Pfizer Investigational Site
      • Irving, Texas, United States, 75063
        • Pfizer Investigational Site
    • Utah
      • Bountiful, Utah, United States, 84010
        • Pfizer Investigational Site
      • Layton, Utah, United States, 84041
        • Pfizer Investigational Site
      • Murray, Utah, United States, 84157
        • Pfizer Investigational Site
      • Provo, Utah, United States, 84604
        • Pfizer Investigational Site
      • Salt Lake City, Utah, United States, 84106
        • Pfizer Investigational Site
      • Salt Lake City, Utah, United States, 84102
        • Pfizer Investigational Site
      • Sandy, Utah, United States, 84094
        • Pfizer Investigational Site
      • West Valley, Utah, United States, 84102
        • Pfizer Investigational Site
    • Washington
      • Kennewick, Washington, United States, 99336
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 2
plus erlotinib 150 mg daily by tablets in a continuous regimen until progression or unacceptable toxicity
Placebo daily by oral capsules in a continuous regimen
EXPERIMENTAL: 1
plus erlotinib 150 mg daily by tablets in a continuous regimen until progression or unacceptable toxicity
Sunitinib 37.5 mg daily by oral capsules in a continuous regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Baseline to death or 28 days after last dose for the last participant
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: Baseline to disease progression or death due to any cause or 28 days after last dose
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
Percentage of Participants With Objective Response (OR)
Time Frame: Baseline to disease progression or discontinuation from study or 28 days after last dose
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
Duration of Response (DR)
Time Frame: Baseline to disease progression or death or discontinuation from study or 28 days after last dose
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
One-year Survival Probability
Time Frame: Baseline until death or until 28 days after last dose for the last participant
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
EuroQol 5-Dimension Questionnaire (EQ-5D)- Health State Profile Utility Score
Time Frame: Baseline and End of Treatment (EOT) or Withdrawal
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (ACTUAL)

July 1, 2010

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

April 4, 2007

First Submitted That Met QC Criteria

April 4, 2007

First Posted (ESTIMATE)

April 6, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

October 29, 2013

Last Update Submitted That Met QC Criteria

September 24, 2013

Last Verified

September 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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