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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:
Eli Lilly and Company Identifier:
First received: July 12, 2004
Last updated: May 8, 2009
Last verified: May 2009

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression free survival [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Time to progressive disease [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: time of response to progressive disease ] [ Designated as safety issue: No ]
  • Time to treatment failure [ Time Frame: baseline to stopping treatment ] [ Designated as safety issue: Yes ]

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
Genders Eligible for Study:   Both
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:
No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Chief Medical Officer, Eli Lilly Identifier: NCT00087711     History of Changes
Other Study ID Numbers: 2938, H3E-MC-JMDB
Study First Received: July 12, 2004
Last Updated: May 8, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses processed this record on November 19, 2014