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

This study has been completed.

First Received on April 24, 2002. Last Updated on July 18, 2006 History of Changes

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00034268

Purpose

The purposes of this study are to determine:

If treatment with LY900003 plus gemcitabine and cisplatin can help you live longer, compared with gemcitabine and cisplatin alone.
The safety of LY900003 plus gemcitabine and cisplatin and any side effects that might be associated with the combination of these three drugs.
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.

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: LY900003	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Gemcitabine Gemcitabine hydrochloride Aprinocarsen

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Study Start Date:

March 2002

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00034268

Show 105 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00034268 History of Changes
Other Study ID Numbers:	6428, H7X-MC-JVAA
Study First Received:	April 24, 2002
Last Updated:	July 18, 2006
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:

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

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Gemcitabine

Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on February 12, 2012