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Pemetrexed and Best Supportive Care Versus Placebo and Best Supportive Care in Non-Small Cell Lung Cancer

This study has been completed.
Information provided by (Responsible Party):
Eli Lilly and Company Identifier:
First received: February 1, 2005
Last updated: December 11, 2013
Last verified: June 2012

This study is a randomized Phase 3, double-blind study of maintenance pemetrexed plus best supportive care versus placebo plus best supportive care in Non Small Cell Lung Cancer (NSCLC). Patients must have received one of six induction regimens for 4 cycles and did not have progressive disease prior to randomization (enrollment) into this trial.

Condition Intervention Phase
Non Small Cell Lung Cancer
Drug: pemetrexed
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Double-Blind, Placebo-Controlled Study of Maintenance Pemetrexed Plus Best Supportive Care Versus Best Supportive Care Immediately Following Induction Treatment for Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Progression-free survival time (PFS) [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival time (OS) [ Time Frame: baseline to date of death from any cause ] [ Designated as safety issue: Yes ]
  • Time to objective progressive disease [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Time to worsening of symptoms [ Time Frame: baseline to stopping treatment ] [ Designated as safety issue: Yes ]
  • Objective tumor response rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
  • Changes in individual symptom scores and quality of life using the Lung Cancer Symptoms Scale (LCSS) [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 660
Study Start Date: March 2005
Study Completion Date: December 2013
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: pemetrexed
500 mg/m2, IV, q 21 days, until disease progression
Other Names:
  • LY231514
  • Alimta
Placebo Comparator: B Drug: Placebo
IV, q 21 days


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

Inclusion Criteria:

  • Histologic or cytologic diagnosis of NSCLC Stage IIIB (with pleural effusion and/or positive supraclavicular lymph nodes) or Stage IV prior to induction therapy.
  • Patients must have had one of the following induction therapies for treatment for Stage IIIB (with pleural effusion and/or positive supraclavicular lymph nodes) or IV NSCLC: Gemcitabine plus carboplatin, paclitaxel plus carboplatin, or docetaxel plus carboplatin, gemcitabine plus cisplatin, paclitaxel plus cisplatin or docetaxel plus cisplatin.
  • Patients must have received only one chemotherapeutic doublet lasting precisely four cycles.
  • Induction regimens must be based on 21-day cycles.
  • Documented evidence of a tumor response of CR, PR or SD. Tumor assessment must occur between Cycle 4 (Day 1) of induction therapy and the date of randomization. This response does not have to be confirmed in order for the patient to be randomized. (Positron emission tomography (PET) scans and ultrasounds may not be used for lesion measurements for response determination.

Exclusion Criteria:

  • With the exception of those chemotherapies listed as inclusion criterion, patients will not be included if they have received prior systemic anticancer therapy (including adjuvant early-stage treatment for NSCLC) or any systemic treatment for any other cancer.
  • Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
  • Inability to comply with protocol or study procedures.
  • A serious concomitant systemic disorder that would compromise the patient's ability to complete the study.
  • A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV.
  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: NCT00102804

  Show 73 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 - 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: Eli Lilly and Company Identifier: NCT00102804     History of Changes
Other Study ID Numbers: 5122, H3E-MC-JMEN
Study First Received: February 1, 2005
Last Updated: December 11, 2013
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
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on November 20, 2014