NCT00363415

Brief 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. It is anticipated that pemetrexed plus carboplatin will offer similar survival benefits as compared to etoposide plus carboplatin.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
908

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Aug 2006

Geographic Reach
25 countries

186 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 15, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

October 6, 2009

Completed
Last Updated

October 28, 2009

Status Verified

October 1, 2009

Enrollment Period

1.8 years

First QC Date

August 10, 2006

Results QC Date

June 5, 2009

Last Update Submit

October 20, 2009

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (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.

    baseline to date of death from any cause (up to 19.6 months)

Secondary Outcomes (4)

  • Overall Survival (Subgroups)

    baseline to date of death from any cause (up to 19.6 months)

  • Progression Free Survival

    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)

    baseline and 6 cycles (21-day cycles)

  • Overall Survival (Subgroups: LDH<=Upper Limit of Normal and History of Brain Metastases=Yes)

    baseline to date of death due to any cause (up to 19.6 months)

Study Arms (2)

A

EXPERIMENTAL
Drug: pemetrexedDrug: carboplatin

B

ACTIVE COMPARATOR
Drug: etoposideDrug: carboplatin

Interventions

pemetrexedDRUG

500 mg/m2, intravenous (IV), every 21 days x 6 cycles

Also known as: LY231514, Alimta
A
etoposideDRUG

100 mg/m2, intravenous (IV), days 1-3 x 6 cycles

B
carboplatinDRUG

Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles

AB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (189)

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Huntsville, Alabama, 35805, United States

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Anchorage, Alaska, 99508, United States

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Fayetteville, Arkansas, 72703, United States

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Burbank, California, 91505, United States

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La Jolla, California, 92093, United States

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Los Angeles, California, 90095, United States

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Mission Hills, California, 91345, United States

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Orange, California, 92868, United States

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Poway, California, 92064, United States

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Fort Myers, Florida, 33916, United States

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Jacksonville, Florida, 32256, United States

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Miami, Florida, 33136, United States

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Orlando, Florida, 32806, United States

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Chicago, Illinois, 60637, United States

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Springfield, Illinois, 62701, United States

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Wichita, Kansas, 67214, United States

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Lexington, Kentucky, 40536, United States

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Louisville, Kentucky, 40402, United States

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Scarborough, Maine, 04074, United States

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Boston, Massachusetts, 02118, United States

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Detroit, Michigan, 48201, United States

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Minneapolis, Minnesota, 55455, United States

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Kansas City, Missouri, 64111, United States

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St Louis, Missouri, 63110, United States

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Lincoln, Nebraska, 68510, United States

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Sparta, New Jersey, 07871, United States

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Albuquerque, New Mexico, 87106, United States

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Santa Fe, New Mexico, 87505, United States

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Chapel Hill, North Carolina, 27599, United States

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Concord, North Carolina, 28025, United States

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Cincinnati, Ohio, 45267, United States

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Columbus, Ohio, 43221, United States

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Zanesville, Ohio, 43701, United States

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Portland, Oregon, 97213, United States

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Dunmore, Pennsylvania, 18512, United States

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East Stroudsburg, Pennsylvania, 18301, United States

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Ephrata, Pennsylvania, 17522, United States

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Media, Pennsylvania, 19063, United States

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Philadelphia, Pennsylvania, 19141, United States

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Wilkes-Barre, Pennsylvania, 18711, United States

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Charleston, South Carolina, 29406, United States

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Columbia, South Carolina, 29210, United States

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Chattanooga, Tennessee, 37404, United States

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Knoxville, Tennessee, 37920, United States

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Memphis, Tennessee, 38120, United States

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Nashville, Tennessee, 37203, United States

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Austin, Texas, 78705, United States

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Dallas, Texas, 75237, United States

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Fort Worth, Texas, 76104, United States

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Houston, Texas, 77060, United States

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San Antonio, Texas, 78258, United States

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Richmond, Virginia, 23298, United States

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Everett, Washington, 98201, United States

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Madison, Wisconsin, 53792, United States

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Bahía Blanca, Argentina

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Buenos Aires, 1427, Argentina

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Mar del Plata, 7600, Argentina

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Rosario, 2000, Argentina

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Tucumain, 4000, Argentina

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Camperdown, New South Wales, 2050, Australia

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Coffs Harbour, New South Wales, 2450, Australia

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Port Macquarie, New South Wales, 2444, Australia

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Wollongong, New South Wales, 2500, Australia

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Brisbane, Queensland, 4029, Australia

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Chermisdie, Queensland, 4032, Australia

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Redcliffe, Queensland, 4020, Australia

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South Brisbane, Queensland, 4101, Australia

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Townsville, Queensland, 4810, Australia

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Adelaide, South Australia, 5000, Australia

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Woodville, South Australia, 5011, Australia

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Hobart, Tasmania, 7001, Australia

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Frankston, Victoria, 3199, Australia

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Geelong, Victoria, 3220, Australia

Location

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Wodonga, Victoria, 3690, Australia

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Graz, 8036, Austria

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Linz, A-4010, Austria

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Vienna, A-1140, Austria

Location

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Brussels, 1090, Belgium

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Edegem, 2650, Belgium

Location

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Leuven, 3000, Belgium

Location

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Liège, 4000, Belgium

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Florianópolis, 88034000, Brazil

Location

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Fortaleza, 60430-230, Brazil

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Jaú, 17210-120, Brazil

Location

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São Paulo, 01277-900, Brazil

Location

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Beijing, 100021, China

Location

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Guangzhou, 510080, China

Location

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Shanghai, 200433, China

Location

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Brest, 29609, France

Location

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Caen, 14033, France

Location

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Clichy, 92118, France

Location

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Grenoble, 38043, France

Location

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Lille, 59020, France

Location

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Lyon, 69317, France

Location

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Marseille, 13009, France

Location

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Montpellier, 34295, France

Location

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Borstel, 23845, Germany

Location

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Cologne, D-51109, Germany

Location

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Freiburg im Breisgau, 79106, Germany

Location

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Gauting, D-82131, Germany

Location

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Großhansdorf, D-22927, Germany

Location

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Hamburg, D-21075, Germany

Location

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Heidelberg, 69126, Germany

Location

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Hemer, D-58675, Germany

Location

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Kassel, 34125, Germany

Location

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Nuremberg, 90419, Germany

Location

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Regensburg, D-93049, Germany

Location

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Rostock, 18057, Germany

Location

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Stralsund, 18435, Germany

Location

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Athens, 11527, Greece

Location

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Heraklion, 71110, Greece

Location

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Marousi Attikis, 15126, Greece

Location

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Pylaia/Thessaloniki, 57001, Greece

Location

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Deszk, 6772, Hungary

Location

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Pécs, 7623, Hungary

Location

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Székesfehérvár, 8000, Hungary

Location

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Szombathely, 9700, Hungary

Location

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Törökbálint, 2045, Hungary

Location

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Zalaegerszeg, 8900, Hungary

Location

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Ahmedabad, 380016, India

Location

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Bangalore, 560027, India

Location

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Kolkata, 700053, India

Location

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Ludhiana, 141001, India

Location

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Mumbai, 400 012, India

Location

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New Delhi, 110029, India

Location

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Pune, 411001, India

Location

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Trivandrum, 695 011, India

Location

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Bergamo, 24128, Italy

Location

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Livorno, 57128, Italy

Location

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Monteforte Irpino, 83024, Italy

Location

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Orbassano, 10043, Italy

Location

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Parma, 43100, Italy

Location

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Ravenna, 48020, Italy

Location

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Rome, 00149, Italy

Location

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San Sisto, 06156, Italy

Location

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's-Hertogenbosch, 5211 NL, Netherlands

Location

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Amsterdam, 1081 HV, Netherlands

Location

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Arnhem, 6815 AD, Netherlands

Location

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Groningen, 9713 GZ, Netherlands

Location

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Harderwijk, 3844 DG, Netherlands

Location

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Heerlen, 4619 PC, Netherlands

Location

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Auckland, 1030, New Zealand

Location

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Christchurch, 8020, New Zealand

Location

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Wellington, 6002, New Zealand

Location

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Gdansk, 80-211, Poland

Location

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Krakow-Nowa Huta, PL-31-826, Poland

Location

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Otwock, 05-400, Poland

Location

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Szczecin-Zdunowo, Poland

Location

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Zabrze-Biskupice, 41-803, Poland

Location

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Coimbra, 3040-853, Portugal

Location

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Lisbon, 1649-035, Portugal

Location

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Porto, 4200-072, Portugal

Location

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Santa Maria da Feira, 4520-211, Portugal

Location

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Vila Nova de Gaia, 4434-502, Portugal

Location

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San Juan, 00921, Puerto Rico

Location

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Bucharest, 022328, Romania

Location

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Cluj-Napoca, 3400, Romania

Location

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Chelyabinsk, 454087, Russia

Location

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Engel's, 413115, Russia

Location

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Kazan', 420029, Russia

Location

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Murmansk, 183047, Russia

Location

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Saint Petersburg, 198255, Russia

Location

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Stavropol, 355047, Russia

Location

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Cape Town, 7925, South Africa

Location

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Durban, 4091, South Africa

Location

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Parktown, 2193, South Africa

Location

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Seoul, 138-736, South Korea

Location

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Alicante, 03010, Spain

Location

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Badalona, 08915, Spain

Location

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Barakaldo, 48903, Spain

Location

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Barcelona, 08907, Spain

Location

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Madrid, 28041, Spain

Location

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Zaragoza, 50009, Spain

Location

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Niao Sung Hsiang, 833, Taiwan

Location

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Taichung, 407, Taiwan

Location

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Taipei, 100, Taiwan

Location

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Besevler/Ankara, 06500, Turkey (Türkiye)

Location

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Gaziantep, Turkey (Türkiye)

Location

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Istanbul, 34760, Turkey (Türkiye)

Location

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Izmir, 35100, Turkey (Türkiye)

Location

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Samsun, 55139, Turkey (Türkiye)

Location

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Bristol, Avon, BS2 8ED, United Kingdom

Location

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Truro, Cornwall, TR1 3LJ, United Kingdom

Location

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Chelmsford, Essex, CM1 7ET, United Kingdom

Location

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.

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

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.

Glasgow, Scotland, G12 0YN, United Kingdom

Location

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.

Birmingham, West Midlands, B15 2TH, United Kingdom

Location

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.

Wolverhampton, West Midlands, WV10 0QP, United Kingdom

Location

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.

Manchester, M20 4BX, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 36184621DERIVED

  • 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.

    PMID: 19720897DERIVED

Related Links

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

PemetrexedEtoposideCarboplatin

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DicarboxylicPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesCoordination Complexes

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 10, 2006

First Posted

August 15, 2006

Study Start

August 1, 2006

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

October 28, 2009

Results First Posted

October 6, 2009

Record last verified: 2009-10

Locations

PT(5)GB(8)GR(4)AU(15)PL(5)RU(6)NL(6)TW(3)IT(8)IN(8)US(54)FR(8)RO(2)BR(4)AR(5)CN(3)BE(4)DE(13)NZ(3)HU(6)PR(1)ES(6)KR(1)TU(5)ZA(3)