Small Cell Lung CancerPhase 3NCT00363415
Study of Pemetrexed and Carboplatin Compared With Etoposide Carboplatin to Treat Extensive-Stage Small Cell Lung Cancer
A Phase 3 study testing pemetrexed, etoposide and carboplatin in people with Small Cell Lung Cancer, run by Eli Lilly and Company at 189 sites in 26 countries.
Trial summary
This study is a Phase 3, global, multi-center, open-label study of patients with extensive-stage small cell lung cancer. Eligible patients will be randomly assigned to receive either pemetrexed plus carboplatin or etoposide plus carboplatin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- pemetrexed, etoposide and carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 908 participants
- Where
- 189 sitesin 26 countries
- Study dates
- Aug 2006to Jun 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of extensive stage small cell lung cancer (SCLC)
- Capable of self-care but may be unable to carry out any work activities.
- No prior anticancer therapy for SCLC
Who cannot join
- have previously participated in a study involving pemetrexed
- have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication
Trial locations and contacts
189 sites in 26 countries.
189 sites in 26 countries
United States54 sites
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Albuquerque, New Mexico, 87106
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Anchorage, Alaska, 99508
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Austin, Texas, 78705
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Boston, Massachusetts, 02118
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Burbank, California, 91505
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Chapel Hill, North Carolina, 27599
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Charleston, South Carolina, 29406
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Chattanooga, Tennessee, 37404
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Chicago, Illinois, 60637
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Cincinnati, Ohio, 45267
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Columbia, South Carolina, 29210
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Columbus, Ohio, 43221
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Concord, North Carolina, 28025
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Dallas, Texas, 75237
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Detroit, Michigan, 48201
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Dunmore, Pennsylvania, 18512
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East Stroudsburg, Pennsylvania, 18301
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Ephrata, Pennsylvania, 17522
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Everett, Washington, 98201
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Fayetteville, Arkansas, 72703
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Fort Myers, Florida, 33916
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Fort Worth, Texas, 76104
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Houston, Texas, 77060
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Huntsville, Alabama, 35805
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Jacksonville, Florida, 32256
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Kansas City, Missouri, 64111
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Knoxville, Tennessee, 37920
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La Jolla, California, 92093
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Lexington, Kentucky, 40536
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Lincoln, Nebraska, 68510
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Los Angeles, California, 90095
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Louisville, Kentucky, 40402
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Madison, Wisconsin, 53792
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Media, Pennsylvania, 19063
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Memphis, Tennessee, 38120
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Miami, Florida, 33136
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Minneapolis, Minnesota, 55455
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Mission Hills, California, 91345
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Nashville, Tennessee, 37203
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Orange, California, 92868
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Orlando, Florida, 32806
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Philadelphia, Pennsylvania, 19141
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Portland, Oregon, 97213
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Poway, California, 92064
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Richmond, Virginia, 23298
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San Antonio, Texas, 78258
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Santa Fe, New Mexico, 87505
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Scarborough, Maine, 04074
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Sparta, New Jersey, 07871
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Springfield, Illinois, 62701
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St Louis, Missouri, 63110
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Wichita, Kansas, 67214
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Wilkes-Barre, Pennsylvania, 18711
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Zanesville, Ohio, 43701
Australia15 sites
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Adelaide, South Australia, 5000
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Brisbane, Queensland, 4029
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Camperdown, New South Wales, 2050
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Chermisdie, Queensland, 4032
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Coffs Harbour, New South Wales, 2450
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Frankston, Victoria, 3199
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Geelong, Victoria, 3220
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Hobart, Tasmania, 7001
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Port Macquarie, New South Wales, 2444
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Redcliffe, Queensland, 4020
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South Brisbane, Queensland, 4101
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Townsville, Queensland, 4810
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Wodonga, Victoria, 3690
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Wollongong, New South Wales, 2500
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Woodville, South Australia, 5011
Germany13 sites
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Borstel, 23845
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Cologne, D-51109
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Freiburg im Breisgau, 79106
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Gauting, D-82131
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Großhansdorf, D-22927
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Hamburg, D-21075
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Heidelberg, 69126
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Hemer, D-58675
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Kassel, 34125
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Nuremberg, 90419
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Regensburg, D-93049
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Rostock, 18057
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Stralsund, 18435
France8 sites
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Brest, 29609
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Caen, 14033
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Clichy, 92118
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Grenoble, 38043
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Lille, 59020
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Lyon, 69317
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Marseille, 13009
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Montpellier, 34295
India8 sites
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Ahmedabad, 380016
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Bangalore, 560027
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Kolkata, 700053
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Ludhiana, 141001
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Mumbai, 400 012
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New Delhi, 110029
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Pune, 411001
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Trivandrum, 695 011
Italy8 sites
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Bergamo, 24128
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Livorno, 57128
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Monteforte Irpino, 83024
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Orbassano, 10043
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Parma, 43100
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Ravenna, 48020
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Rome, 00149
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San Sisto, 06156
United Kingdom8 sites
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Aberdeen, Scotland, AB25 2ZN
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Birmingham, West Midlands, B15 2TH
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Bristol, Avon, BS2 8ED
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Chelmsford, Essex, CM1 7ET
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Glasgow, Scotland, G12 0YN
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Manchester, M20 4BX
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Truro, Cornwall, TR1 3LJ
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Wolverhampton, West Midlands, WV10 0QP
Hungary6 sites
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Deszk, 6772
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Pécs, 7623
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Székesfehérvár, 8000
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Szombathely, 9700
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Törökbálint, 2045
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Zalaegerszeg, 8900
Netherlands6 sites
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's-Hertogenbosch, 5211 NL
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Amsterdam, 1081 HV
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Arnhem, 6815 AD
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Groningen, 9713 GZ
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Harderwijk, 3844 DG
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Heerlen, 4619 PC
Russia6 sites
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Chelyabinsk, 454087
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Engel's, 413115
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Kazan', 420029
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Murmansk, 183047
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Saint Petersburg, 198255
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Stavropol, 355047
Spain6 sites
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Alicante, 03010
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Badalona, 08915
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Barakaldo, 48903
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Barcelona, 08907
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Madrid, 28041
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Zaragoza, 50009
Argentina5 sites
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Bahía Blanca
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Buenos Aires, 1427
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Mar del Plata, 7600
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Rosario, 2000
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Tucumain, 4000
Poland5 sites
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Gdansk, 80-211
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Krakow-Nowa Huta, PL-31-826
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Otwock, 05-400
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Szczecin-Zdunowo
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Zabrze-Biskupice, 41-803
Portugal5 sites
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Coimbra, 3040-853
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Lisbon, 1649-035
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Porto, 4200-072
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Santa Maria da Feira, 4520-211
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Vila Nova de Gaia, 4434-502
Turkey (Türkiye)5 sites
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Besevler/Ankara, 06500
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Gaziantep
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Istanbul, 34760
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Izmir, 35100
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Samsun, 55139
Belgium4 sites
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Brussels, 1090
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Edegem, 2650
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Leuven, 3000
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Liège, 4000
Brazil4 sites
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Florianópolis, 88034000
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Fortaleza, 60430-230
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Jaú, 17210-120
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São Paulo, 01277-900
Greece4 sites
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Athens, 11527
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Heraklion, 71110
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Marousi Attikis, 15126
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Pylaia/Thessaloniki, 57001
Austria3 sites
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Graz, 8036
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Linz, A-4010
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Vienna, A-1140
China3 sites
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Beijing, 100021
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Guangzhou, 510080
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Shanghai, 200433
New Zealand3 sites
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Auckland, 1030
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Christchurch, 8020
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Wellington, 6002
South Africa3 sites
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Cape Town, 7925
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Durban, 4091
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Parktown, 2193
Taiwan3 sites
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Niao Sung Hsiang, 833
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Taichung, 407
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Taipei, 100
Romania2 sites
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Bucharest, 022328
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Cluj-Napoca, 3400
Puerto Rico1 site
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San Juan, 00921
South Korea1 site
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Seoul, 138-736
About this study
Official title: A Randomized Phase 3 Trial of Alimta (Pemetrexed) and Carboplatin Versus Etoposide and Carboplatin in Extensive-Stage Small Cell Lung Cancer
This study is a Phase 3, global, multi-center, open-label study of patients with extensive-stage small cell lung cancer. Eligible patients will be randomly assigned to receive either pemetrexed plus carboplatin or etoposide plus carboplatin. It is anticipated that pemetrexed plus carboplatin will offer similar survival benefits as compared to etoposide plus carboplatin.
- Conditions
- Small Cell Lung Cancer
- Being tested
- pemetrexed, etoposide, carboplatin
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pemetrexedDrug
Also called LY231514, Alimta
500 mg/m2, intravenous (IV), every 21 days x 6 cycles
etoposideDrug
100 mg/m2, intravenous (IV), days 1-3 x 6 cycles
carboplatinDrug
Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: pemetrexed; Drug: carboplatin |
| B | Active comparator | Not described Receives: Drug: etoposide; Drug: carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.
Measured: baseline to date of death from any cause (up to 19.6 months)
Secondary outcomes (4)
Overall Survival (Subgroups)
The effects of individual baseline factors (sex, race, Eastern Cooperative Oncology Group (ECOG) performance, region, lactate dehydrogenase (LDH), age, number of metastatic sites, and history of brain metastases) on overall survival are reported. For two subgroups - LDH<=upper limit of normal and brain metastases=yes, the upper limits of the 95% confidence interval were not calculable for the etoposide+carboplatin group - instead the number of participants in these two subgroups are presented as a post-hoc outcome measure.
Measured: baseline to date of death from any cause (up to 19.6 months)
Progression Free Survival
The period from study entry until disease progression, death or date of last contact.
Measured: baseline to measured progressive disease (up to 14.7 months)
Change From Baseline to Each Cycle in Functional Assessment of Cancer Therapy - Lung (FACT-L)
FACT-L measures following domains of health-related quality of life (HR-QL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of lung cancer. Total scores range from 0 to 136, with higher scores representing better HR-QL. A clinically meaningful change is considered to be 5 points.
Measured: baseline and 6 cycles (21-day cycles)
Overall Survival (Subgroups: LDH<=Upper Limit of Normal and History of Brain Metastases=Yes)
The effects of individual baseline factors (lactate dehydrogenase (LDH) and history of brain metastases) on overall survival are reported. The Upper Limits of the 95% Confidence Intervals were not calculable for these factors in the Etoposide+Carboplatin group. The number of participants in these subgroup are instead presented as a Post-Hoc Outcome Measure.
Measured: baseline to date of death due to any cause (up to 19.6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 908 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00363415
- Sponsor's protocol ID
- 9691
- Other IDs
- H3E-MC-JMHO
- Status last verified
- Oct 2009
- First submitted
- 10 Aug 2006
- Last updated
- 28 Oct 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Marzano L, Darwich AS, Dan A, Tendler S, Lewensohn R, De Petris L, Raghothama J, Meijer S. Exploring the discrepancies between clinical trials and real-world data: A small-cell lung cancer study. Clin Transl Sci. 2024 Aug;17(8):e13909. doi: 10.1111/cts.13909.
PubMed 39113428Ventz S, Khozin S, Louv B, Sands J, Wen PY, Rahman R, Comment L, Alexander BM, Trippa L. The design and evaluation of hybrid controlled trials that leverage external data and randomization. Nat Commun. 2022 Oct 2;13(1):5783. doi: 10.1038/s41467-022-33192-1.
PubMed 36184621Socinski MA, Smit EF, Lorigan P, Konduri K, Reck M, Szczesna A, Blakely J, Serwatowski P, Karaseva NA, Ciuleanu T, Jassem J, Dediu M, Hong S, Visseren-Grul C, Hanauske AR, Obasaju CK, Guba SC, Thatcher N. Phase III study of pemetrexed plus carboplatin compared with etoposide plus carboplatin in chemotherapy-naive patients with extensive-stage small-cell lung cancer. J Clin Oncol. 2009 Oct 1;27(28):4787-92. doi: 10.1200/JCO.2009.23.1548. Epub 2009 Aug 31.
PubMed 19720897
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 3 Trial of Alimta (Pemetrexed) and Carboplatin Versus Etoposide and Carboplatin in Extensive-Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00363415
- Acronym / sponsor ID
- 9691
- Conditions
- Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 908 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 15 Aug 2006 (estimated)
- Results
- Posted 6 Oct 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a Phase 3, global, multi-center, open-label study of patients with extensive-stage small cell lung cancer. Eligible patients will be randomly assigned to receive either pemetrexed plus carboplatin or etoposide plus carboplatin. It is anticipated that pemetrexed plus carboplatin will offer similar survival benefits as compared to etoposide plus carboplatin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: pemetrexed, Drug: carboplatin |
| B | Active comparator | Drug: etoposide, Drug: carboplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of extensive stage small cell lung cancer (SCLC)
- Capable of self-care but may be unable to carry out any work activities.
- No prior anticancer therapy for SCLC
Key exclusion criteria (2 listed)
- have previously participated in a study involving pemetrexed
- have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pemetrexedAlso: LY231514, Alimta500 mg/m2, intravenous (IV), every 21 days x 6 cycles | Drug | A |
| etoposide100 mg/m2, intravenous (IV), days 1-3 x 6 cycles | Drug | B |
| carboplatinArea under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles | Drug | A, B |
Primary outcome
Overall Survival
Time frame: baseline to date of death from any cause (up to 19.6 months)
Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.
4 secondary outcomes
Overall Survival (Subgroups)
Time frame: baseline to date of death from any cause (up to 19.6 months)
Progression Free Survival
Time frame: baseline to measured progressive disease (up to 14.7 months)
Change From Baseline to Each Cycle in Functional Assessment of Cancer Therapy - Lung (FACT-L)
Time frame: baseline and 6 cycles (21-day cycles)
Overall Survival (Subgroups: LDH<=Upper Limit of Normal and History of Brain Metastases=Yes)
Time frame: baseline to date of death due to any cause (up to 19.6 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39113428Marzano L, Darwich AS, Dan A, Tendler S, Lewensohn R, De Petris L, Raghothama J, Meijer S. Exploring the discrepancies between clinical trials and real-world data: A small-cell lung cancer study. Clin Transl Sci. 2024 Aug;17(8):e13909. doi: 10.1111/cts.13909.
- Derived from this study: PubMed 36184621Ventz S, Khozin S, Louv B, Sands J, Wen PY, Rahman R, Comment L, Alexander BM, Trippa L. The design and evaluation of hybrid controlled trials that leverage external data and randomization. Nat Commun. 2022 Oct 2;13(1):5783. doi: 10.1038/s41467-022-33192-1.
- Derived from this study: PubMed 19720897Socinski MA, Smit EF, Lorigan P, Konduri K, Reck M, Szczesna A, Blakely J, Serwatowski P, Karaseva NA, Ciuleanu T, Jassem J, Dediu M, Hong S, Visseren-Grul C, Hanauske AR, Obasaju CK, Guba SC, Thatcher N. Phase III study of pemetrexed plus carboplatin compared with etoposide plus carboplatin in chemotherapy-naive patients with extensive-stage small-cell lung cancer. J Clin Oncol. 2009 Oct 1;27(28):4787-92. doi: 10.1200/JCO.2009.23.1548. Epub 2009 Aug 31.
- Lilly Clinical Trial RegistryLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
189 sites in 26 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pemetrexed, etoposide and carboplatin in people with Small Cell Lung Cancer, run by Eli Lilly and Company at 189 sites in 26 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 189 sites in United States, Australia, Germany, France, India and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Oct 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: baseline to date of death from any cause (up to 19.6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00363415, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2009.