A Phase 3 Trial of LY900003 Plus Gemcitabine and Cisplatin Versus Gemcitabine and Cisplatin in Patients With Advanced, Previously Untreated Non-Small Cell Lung Cancer

July 18, 2006 updated by: Eli Lilly and Company

The purposes of this study are to determine:

  1. If treatment with LY900003 plus gemcitabine and cisplatin can help you live longer, compared with gemcitabine and cisplatin alone.
  2. The safety of LY900003 plus gemcitabine and cisplatin and any side effects that might be associated with the combination of these three drugs.
  3. Whether LY900003 plus gemcitabine and cisplatin can make your tumor smaller or disappear, and for how long, compared with gemcitabine and cisplatin alone.

It is possible that information collected during this study will be analyzed by the sponsor in the future to evaluate LY900003 plus gemcitabine and cisplatin for other possible uses or for other medical or scientific purposes other than those currently proposed.

LY900003 may not add any benefit to gemcitabine plus cisplatin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

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

Study Locations

  • Argentina
      • Ciudad De Buenos Aires, Argentina
      • Mendoza, Argentina
  • Belgium
      • Brasschaat, Belgium
      • Edegem, Belgium
      • Liege, Belgium
      • Merksem, Belgium
      • Oostende, Belgium
  • Chile
    • Santiago
      • Las Condes, Santiago, Chile
  • France
      • Brest, France
      • Nice Cedex 1, France
      • Paris Cedex 20, France
      • Pessac Cedex, France
      • Rouen Cedex, France
      • Saint Herblain Cedex, France
      • Tours Cedex, France
      • Vandoeuvre Les Nancy Cedex, France
  • Germany
      • Augsburg, Germany
      • Berlin, Germany
      • Freiburg, Germany
      • Grobhansdorf, Germany
      • Hamburg, Germany
      • Heidelberg, Germany
      • Hofheim, Germany
      • Koin, Germany
      • Leipzig, Germany
      • Munchen, Germany
      • Neustadt/Suedharz, Germany
      • Trier, Germany
      • Ulm, Germany
    • Hessen
      • Frankfurt, Hessen, Germany
  • Hungary
      • Budapest, Hungary
  • India
      • New Dehli, India
    • Karnataka
      • Bangalore, Karnataka, India
    • Maharashtra
      • Mumbai, Maharashtra, India
      • Pune, Maharashtra, India
    • Punjab
      • Ludhiana, Punjab, India
  • Italy
      • Perugia, Italy
      • Pisa, Italy
      • Ravenna, Italy
      • Roma, Italy
    • Milano
      • Rozzano, Milano, Italy
  • Netherlands
      • Amsterdam, Netherlands
      • Arnhem, Netherlands
      • Den Bosch, Netherlands
      • Groningen, Netherlands
      • Nieuwegien, Netherlands
      • Zwolle, Netherlands
  • Norway
      • Oslo, Norway
  • Poland
      • Krakow-Nowa Huta, Poland
      • Warszawa, Poland
      • Wroclaw, Poland
    • Mazowieckie
      • Otwock, Mazowieckie, Poland
  • Puerto Rico
      • Bayamon, Puerto Rico
      • Ponce, Puerto Rico
  • Romania
    • Cluj
      • Cluj Napoca, Cluj, Romania
  • Russian Federation
      • Moscow, Russian Federation
  • South Africa
      • Durban, South Africa
      • Parklands, South Africa
      • Tygerberg, South Africa
    • Durban
      • Overport, Durban, South Africa
    • Gauteng
      • Arcadia, Gauteng, South Africa
  • Spain
      • Alicante, Spain
      • Barcelona, Spain
      • Madrid, Spain
      • Palma De Mallorca, Spain
      • Zaragoza, Spain
    • Asturias
      • Oviedo, Asturias, Spain
    • Barcelona
      • Badalona, Barcelona, Spain
      • Sabadell, Barcelona, Spain
    • Valenica
      • Valencia, Valenica, Spain
    • Vizcaya
      • Barakaldo, Vizcaya, Spain
  • Sweden
      • Linkoping, Sweden
      • Lund, Sweden
      • Stockhlom, Sweden
  • Switzerland
      • Zurich, Switzerland
  • Taiwan
      • Taipei, Taiwan
    • Kuei-Shan
      • Tao-Yuan, Kuei-Shan, Taiwan
    • Taiwan, Province of China
      • Taichung, Taiwan, Province of China, Taiwan
  • United Kingdom
    • East Yorkshire
      • Hull, East Yorkshire, United Kingdom
    • Greater London
      • London, Greater London, United Kingdom
    • Hampshire
      • Southampton, Hampshire, United Kingdom
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom
    • Scotland
      • Glasgow, Scotland, United Kingdom
    • South Glamorgan
      • Cardiff, South Glamorgan, United Kingdom
    • Tyneside
      • Newcastle-Upon-Tyne, Tyneside, United Kingdom
  • United States
    • Arkansas
      • Hot Springs, Arkansas, United States
      • Springdale, Arkansas, United States
    • California
      • Los Angeles, California, United States
      • Santa Rosa, California, United States
    • Colorado
      • Denver, Colorado, United States
      • Fort Collins, Colorado, United States
    • Delaware
      • Wilmington, Delaware, United States
    • Georgia
      • Tucker, Georgia, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Louisiana
      • New Orleans, Louisiana, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Michigan
      • Detroit, Michigan, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
      • Robbinsdale, Minnesota, United States
    • New York
      • Latham, New York, United States
      • New York, New York, United States
    • Texas
      • Arlington, Texas, United States
      • Dallas, Texas, United States
    • Virginia
      • Abingdon, Virginia, United States
    • Wisconsin
      • Marshfield, Wisconsin, United States

Participation Criteria

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

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Stage IIIB or IV non-small lung cancer
  2. Able to visit the doctor's office
  3. At least 18 years of age
  4. Adequate kidney, adrenal, and liver function

Exclusion Criteria:

  1. Prior chemotherapy or biologic therapy for NSCLC
  2. Central nervous system tumors
  3. Pregnant or breastfeeding

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

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

Sponsor

Eli Lilly and Company

Study record dates

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

Study Major Dates

Study Start

March 1, 2002

Study Registration Dates

First Submitted

April 24, 2002

First Submitted That Met QC Criteria

April 24, 2002

First Posted (Estimate)

April 25, 2002

Study Record Updates

Last Update Posted (Estimate)

July 19, 2006

Last Update Submitted That Met QC Criteria

July 18, 2006

Last Verified

July 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6428
  • H7X-MC-JVAA

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

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