AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Albuquerque, New Mexico, 87106

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Anchorage, Alaska, 99508

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    Austin, Texas, 78705

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Boston, Massachusetts, 02118

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    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

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Miami, Florida, 33136

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Minneapolis, Minnesota, 55455

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Mission Hills, California, 91345

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    Nashville, Tennessee, 37203

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Orange, California, 92868

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    Orlando, Florida, 32806

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    Philadelphia, Pennsylvania, 19141

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Portland, Oregon, 97213

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    Poway, California, 92064

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Richmond, Virginia, 23298

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    San Antonio, Texas, 78258

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Santa Fe, New Mexico, 87505

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Scarborough, Maine, 04074

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Sparta, New Jersey, 07871

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Springfield, Illinois, 62701

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    St Louis, Missouri, 63110

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Wichita, Kansas, 67214

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Wilkes-Barre, Pennsylvania, 18711

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Zanesville, Ohio, 43701

Other trials in United States

Australia15 sites
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Adelaide, South Australia, 5000

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Brisbane, Queensland, 4029

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Camperdown, New South Wales, 2050

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Chermisdie, Queensland, 4032

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Coffs Harbour, New South Wales, 2450

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Frankston, Victoria, 3199

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Geelong, Victoria, 3220

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Hobart, Tasmania, 7001

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Port Macquarie, New South Wales, 2444

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Redcliffe, Queensland, 4020

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    South Brisbane, Queensland, 4101

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Townsville, Queensland, 4810

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Wodonga, Victoria, 3690

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Wollongong, New South Wales, 2500

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Woodville, South Australia, 5011

Other trials in Australia

Germany13 sites
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Borstel, 23845

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Cologne, D-51109

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Freiburg im Breisgau, 79106

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Gauting, D-82131

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Großhansdorf, D-22927

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Hamburg, D-21075

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Heidelberg, 69126

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Hemer, D-58675

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Kassel, 34125

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Nuremberg, 90419

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Regensburg, D-93049

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Rostock, 18057

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Stralsund, 18435

Other trials in Germany

France8 sites
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Brest, 29609

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Caen, 14033

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Clichy, 92118

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Grenoble, 38043

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Lille, 59020

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Lyon, 69317

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Marseille, 13009

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Montpellier, 34295

Other trials in France

India8 sites
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Ahmedabad, 380016

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Bangalore, 560027

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Kolkata, 700053

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    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

Other trials in India

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

Other trials in Italy

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

Other trials in United Kingdom

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

Other trials in Hungary

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

Other trials in Netherlands

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

Other trials in Russia

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

Other trials in Spain

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

Other trials in Argentina

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

Other trials in Poland

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

Other trials in Portugal

Turkey (Türkiye)5 sites
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    Besevler/Ankara, 06500

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Gaziantep

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Istanbul, 34760

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Izmir, 35100

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    Samsun, 55139

Other trials in Turkey (Türkiye)

Belgium4 sites
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    Brussels, 1090

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    Edegem, 2650

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Leuven, 3000

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Liège, 4000

Other trials in Belgium

Brazil4 sites
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    Florianópolis, 88034000

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Fortaleza, 60430-230

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    Jaú, 17210-120

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    São Paulo, 01277-900

Other trials in Brazil

Greece4 sites
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Athens, 11527

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Heraklion, 71110

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Marousi Attikis, 15126

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Pylaia/Thessaloniki, 57001

Other trials in Greece

Austria3 sites
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    Graz, 8036

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Linz, A-4010

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    Vienna, A-1140

Other trials in Austria

China3 sites
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    Beijing, 100021

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    Guangzhou, 510080

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    Shanghai, 200433

Other trials in China

New Zealand3 sites
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    Auckland, 1030

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    Christchurch, 8020

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    Wellington, 6002

Other trials in New Zealand

South Africa3 sites
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    Cape Town, 7925

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    Durban, 4091

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    Parktown, 2193

Other trials in South Africa

Taiwan3 sites
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    Niao Sung Hsiang, 833

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    Taichung, 407

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    Taipei, 100

Other trials in Taiwan

Romania2 sites
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    Bucharest, 022328

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    Cluj-Napoca, 3400

Other trials in Romania

Puerto Rico1 site
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    San Juan, 00921

Other trials in Puerto Rico

South Korea1 site
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    Seoul, 138-736

Other trials in South Korea

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.

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 groups in NCT00363415
Study groupRoleWhat they receive
AExperimentalNot described
Receives: Drug: pemetrexed; Drug: carboplatin
BActive comparatorNot described
Receives: Drug: etoposide; Drug: carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. 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)

  2. 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)

  3. 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)

  4. 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.

  1. First posted15 Aug 2006 (estimated)
  2. Study startAug 2006
  3. Primary completionJun 2008
  4. Study completionJun 2008

Resources

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)
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
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 39113428
  • Ventz 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 36184621
  • Socinski 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

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.

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