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OpenTrials
Completed

NCT Number: NCT00034268

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

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.

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mendoza, Mendoza Province, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Prior chemotherapy or biologic therapy for NSCLC
  • Central nervous system tumors
  • Pregnant or breastfeeding

Treatment and study plan

LY900003

Drug

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Important dates

Study start
2002
First posted
Apr 25, 2002
Registry last updated
Jul 19, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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