Study of Pemetrexed and Carboplatin Compared With Etoposide Carboplatin to Treat Extensive-Stage Small Cell Lung Cancer

NCT ID: NCT00363415

Last Updated: 2009-10-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

908 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2008-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

pemetrexed

Intervention Type DRUG

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

carboplatin

Intervention Type DRUG

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

B

Group Type ACTIVE_COMPARATOR

etoposide

Intervention Type DRUG

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

carboplatin

Intervention Type DRUG

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

Interventions

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pemetrexed

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

Intervention Type DRUG

etoposide

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

Intervention Type DRUG

carboplatin

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

Intervention Type DRUG

Other Intervention Names

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LY231514 Alimta

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Eli Lilly

Principal Investigators

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Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Boston, Massachusetts, United States

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Portland, Oregon, United States

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Dunmore, Pennsylvania, United States

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Bahía Blanca, , Argentina

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Mar del Plata, , Argentina

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Rosario, , Argentina

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Redcliffe, Queensland, Australia

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Woodville, South Australia, Australia

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Hobart, Tasmania, Australia

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Frankston, Victoria, Australia

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Geelong, Victoria, Australia

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Wodonga, Victoria, Australia

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Graz, , Austria

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Linz, , Austria

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Vienna, , Austria

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Brussels, , Belgium

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Edegem, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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Florianópolis, , Brazil

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Fortaleza, , Brazil

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Jaú, , Brazil

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São Paulo, , Brazil

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Beijing, , China

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Guangzhou, , China

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Shanghai, , China

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Brest, , France

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Caen, , France

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Clichy, , France

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Grenoble, , France

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Lille, , France

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Lyon, , France

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Marseille, , France

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Montpellier, , France

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Borstel, , Germany

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Cologne, , Germany

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Freiburg im Breisgau, , Germany

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Gauting, , Germany

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Großhansdorf, , Germany

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Hamburg, , Germany

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Heidelberg, , Germany

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Hemer, , Germany

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Kassel, , Germany

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Nuremberg, , Germany

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Regensburg, , Germany

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Rostock, , Germany

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Stralsund, , Germany

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Athens, , Greece

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Heraklion, , Greece

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Marousi Attikis, , Greece

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Pylaia/Thessaloniki, , Greece

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Deszk, , Hungary

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Pécs, , Hungary

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Székesfehérvár, , Hungary

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Szombathely, , Hungary

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Törökbálint, , Hungary

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Zalaegerszeg, , Hungary

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Ahmedabad, , India

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Bangalore, , India

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Kolkata, , India

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Ludhiana, , India

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Mumbai, , India

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New Delhi, , India

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Pune, , India

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Trivandrum, , India

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Bergamo, , Italy

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Livorno, , Italy

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Monteforte Irpino, , Italy

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Orbassano, , Italy

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Parma, , Italy

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Ravenna, , Italy

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Rome, , Italy

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San Sisto, , Italy

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's-Hertogenbosch, , Netherlands

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Amsterdam, , Netherlands

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Arnhem, , Netherlands

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Groningen, , Netherlands

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Harderwijk, , Netherlands

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Heerlen, , Netherlands

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Auckland, , New Zealand

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Christchurch, , New Zealand

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Wellington, , New Zealand

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Gdansk, , Poland

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Krakow-Nowa Huta, , Poland

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Otwock, , Poland

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Szczecin-Zdunowo, , Poland

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Zabrze-Biskupice, , Poland

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Coimbra, , Portugal

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Lisbon, , Portugal

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Porto, , Portugal

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Santa Maria da Feira, , Portugal

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Vila Nova de Gaia, , Portugal

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San Juan, , Puerto Rico

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Bucharest, , Romania

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Cluj-Napoca, , Romania

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Chelyabinsk, , Russia

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Engel's, , Russia

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Kazan', , Russia

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Murmansk, , Russia

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Saint Petersburg, , Russia

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Stavropol, , Russia

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Cape Town, , South Africa

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Durban, , South Africa

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Parktown, , South Africa

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Seoul, , South Korea

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Alicante, , Spain

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Badalona, , Spain

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Barakaldo, , Spain

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Barcelona, , Spain

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Madrid, , Spain

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Zaragoza, , Spain

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Niao Sung Hsiang, , Taiwan

Site Status

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Taichung, , Taiwan

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Taipei, , Taiwan

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Besevler/Ankara, , Turkey (Türkiye)

Site Status

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Gaziantep, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

Site Status

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Izmir, , Turkey (Türkiye)

Site Status

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Samsun, , Turkey (Türkiye)

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Bristol, Avon, United Kingdom

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Truro, Cornwall, United Kingdom

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Chelmsford, Essex, United Kingdom

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Aberdeen, Scotland, United Kingdom

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Glasgow, Scotland, United Kingdom

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Birmingham, West Midlands, United Kingdom

Site Status

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, United Kingdom

Site Status

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, , United Kingdom

Site Status

Countries

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United States Argentina Australia Austria Belgium Brazil China France Germany Greece Hungary India Italy Netherlands New Zealand Poland Portugal Puerto Rico Romania Russia South Africa South Korea Spain Taiwan Turkey (Türkiye) United Kingdom

References

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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.

Reference Type DERIVED
PMID: 36184621 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19720897 (View on PubMed)

Other Identifiers

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H3E-MC-JMHO

Identifier Type: -

Identifier Source: secondary_id

9691

Identifier Type: -

Identifier Source: org_study_id

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