CClinicalTrials.gg
CompletedNCT00034268Updated Jul 19, 2006

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

A Phase 3 interventional study of LY900003 in Carcinoma, Non-Small-Cell Lung, sponsored by Eli Lilly and Company. Completed at 105 sites in 21 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2006-07-19.

Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Carcinoma, Non-Small-Cell Lung

Keywords

  • non-small cell lung cancer
  • Stage IIIB or IV non-small cell lung cancer (NSCLC)
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

Browse Lung Neoplasms studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  1. Prior chemotherapy or biologic therapy for NSCLC
  2. Central nervous system tumors
  3. Pregnant or breastfeeding
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)

Interventions

  • DrugLY900003
06

Study locations

105 sites
  • Hot Springs, Arkansas, United States
  • Springdale, Arkansas, United States
  • Los Angeles, California, United States
  • Santa Rosa, California, United States
  • Denver, Colorado, United States
  • Fort Collins, Colorado, United States
  • Wilmington, Delaware, United States
  • Tucker, Georgia, United States
  • Indianapolis, Indiana, United States
  • New Orleans, Louisiana, United States
  • Baltimore, Maryland, United States
  • Detroit, Michigan, United States
  • Minneapolis, Minnesota, United States
  • Robbinsdale, Minnesota, United States
  • Latham, New York, United States
  • New York, New York, United States
  • Arlington, Texas, United States
  • Dallas, Texas, United States
  • Abingdon, Virginia, United States
  • Marshfield, Wisconsin, United States
  • Ciudad De Buenos Aires, Argentina
  • Mendoza, Argentina
  • Brasschaat, Belgium
  • Edegem, Belgium
  • Liege, Belgium
  • Merksem, Belgium
  • Oostende, Belgium
  • Las Condes, Santiago, Chile
  • 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
  • Frankfurt, Hessen, 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
  • Budapest, Hungary
  • Bangalore, Karnataka, India
  • Mumbai, Maharashtra, India
  • Pune, Maharashtra, India
  • Ludhiana, Punjab, India
  • New Dehli, India
  • Rozzano, Milano, Italy
  • Perugia, Italy
  • Pisa, Italy
  • Ravenna, Italy
  • Roma, Italy
  • Amsterdam, Netherlands
  • Arnhem, Netherlands
  • Den Bosch, Netherlands
  • Groningen, Netherlands
  • Nieuwegien, Netherlands
  • Zwolle, Netherlands
  • Oslo, Norway
  • Otwock, Mazowieckie, Poland
  • Krakow-Nowa Huta, Poland
  • Warszawa, Poland
  • Wroclaw, Poland
  • Bayamon, Puerto Rico
  • Ponce, Puerto Rico
  • Cluj Napoca, Cluj, Romania
  • Moscow, Russian Federation
  • Overport, Durban, South Africa
  • Arcadia, Gauteng, South Africa
  • Durban, South Africa
  • Parklands, South Africa
  • Tygerberg, South Africa
  • Oviedo, Asturias, Spain
  • Badalona, Barcelona, Spain
  • Sabadell, Barcelona, Spain
  • Valencia, Valenica, Spain
  • Barakaldo, Vizcaya, Spain
  • Alicante, Spain
  • Barcelona, Spain
  • Madrid, Spain
  • Palma De Mallorca, Spain
  • Zaragoza, Spain
  • Linkoping, Sweden
  • Lund, Sweden
  • Stockhlom, Sweden
  • Zurich, Switzerland
  • Tao-Yuan, Kuei-Shan, Taiwan
  • Taichung, Taiwan, Province of China, Taiwan
  • Taipei, Taiwan
  • Hull, East Yorkshire, United Kingdom
  • London, Greater London, United Kingdom

Showing the first 100 of 105 sites across 21 countries.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00034268
Lead sponsor
Eli Lilly and Company
First posted
Apr 25, 2002
Start date
Mar 2002
Last update
Jul 19, 2006
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2006. You cannot join it, but the record below documents what was studied.

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