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A Randomized Phase 3 Trial of Pemetrexed and Cisplatin Versus Gemcitabine and Cisplatin in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer

This study has been completed.
Information provided by (Responsible Party):
Eli Lilly and Company Identifier:
First received: July 12, 2004
Last updated: November 21, 2016
Last verified: November 2016
This study is a randomized Phase 3 study comparing pemetrexed and cisplatin combination to gemcitabine and cisplatin for the treatment of Non Small Cell Lung Cancer (NCSLC). Gemcitabine plus cisplatin is currently the standard of care for NSCLC. It is thought that pemetrexed plus cisplatin may be as effective and may have fewer side effects than the standard of care.

Condition Intervention Phase
Non Small Cell Lung Carcinoma Drug: pemetrexed Drug: gemcitabine Drug: cisplatin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase 3 Trial of ALIMTA and Cisplatin Versus GEMZAR and Cisplatin in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Resource links provided by NLM:

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Overall survival [ Time Frame: baseline to date of death from any cause ]

Secondary Outcome Measures:
  • Progression free survival [ Time Frame: baseline to measured progressive disease ]
  • Time to progressive disease [ Time Frame: baseline to measured progressive disease ]
  • Duration of response [ Time Frame: time of response to progressive disease ]
  • Time to treatment failure [ Time Frame: baseline to stopping treatment ]

Enrollment: 1713
Study Start Date: July 2004
Study Completion Date: March 2008
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: pemetrexed
500 mg/m2, IV q 21 days x 6 cycles
Other Names:
  • LY231514
  • Alimta
Drug: cisplatin
75 mg/m2, IV, q 21 days x 6 cycles
Active Comparator: B Drug: gemcitabine
1250 mg/m2, IV, day 1 and 8 q 21 days x 6 cycles
Other Names:
  • LY188011
  • Gemzar
Drug: cisplatin
75 mg/m2, IV, q 21 days x 6 cycles


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

Inclusion Criteria:

  • Diagnosis of NSCLC Stage IIIB not amenable to curative treatment or Stage IV.
  • No prior chemotherapy for lung cancer.
  • Patients must have at least one uni-dimensionally measurable lesion.
  • Prior radiation therapy to less than 25% of bone marrow, whole pelvis not allowed. Radiation must be completed at least 4 weeks prior to study enrollment.

Exclusion Criteria:

  • Treatment with any drug within the last 30 days that has not received regulatory approval.
  • Serious cardiac condition.
  • Serious medical disorder in addition to NSCLC that would make it difficult for the patient to complete the study.
  • Inability or unwillingness to take folic acid or Vitamin B12 supplementation.
  • Presence of fluid retention that cannot be controlled by drainage.
  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: NCT00087711

  Show 134 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Eli Lilly and Company Identifier: NCT00087711     History of Changes
Other Study ID Numbers: 2938
H3E-MC-JMDB ( Other Identifier: Eli Lilly and Company )
Study First Received: July 12, 2004
Last Updated: November 21, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

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
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
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 July 21, 2017