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Comparing 3 Schedules of Alimta Plus Gemzar

This study has been completed.
Information provided by:
Eli Lilly and Company Identifier:
First received: May 1, 2002
Last updated: July 18, 2006
Last verified: July 2006
The purpose of the study is to measure tumor response rates for three schedules of Alimta(LY231514) in combination with gemcitabine in patients with locally advanced or metastatic non small cell lung cancer who have received no prior chemotherapy regimen.

Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Drug: Pemetrexed (Alimta) in combination with gemcitabine (Gemzar)
Phase 2

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

Resource links provided by NLM:

Further study details as provided by Eli Lilly and Company:


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of non-small lung cancer
  • No prior chemotherapy
  • Able to care for self

Exclusion Criteria:

  • An ongoing infection
  • Pregnancy or breast feeding
  • Other serious medical condition
  • Cancer that has spread to the brain
  • Inability to take folic acid
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00034606

United States, Minnesota
Rochester, Minnesota, United States
Sponsors and Collaborators
Eli Lilly and Company
  More Information Identifier: NCT00034606     History of Changes
Other Study ID Numbers: 5115  H3E-MC-JMEL 
Study First Received: May 1, 2002
Last Updated: July 18, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors processed this record on October 20, 2016