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

• ClinicalTrials.gov Identifier: NCT00087711
• Recruitment Status: Completed
• First Posted: July 16, 2004
• Last Update Posted: September 12, 2019
• Sponsor: Eli Lilly and Company
• Information provided by (Responsible Party): Eli Lilly and Company

Tracking Information

• First Submitted Date: July 12, 2004
• First Posted Date: July 16, 2004
• Last Update Posted Date: September 12, 2019
• Study Start Date: July 2004
• Actual Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 20, 2007): Overall survival [ Time Frame: baseline to date of death from any cause ]
• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: December 20, 2007)

• 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 ]

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Non Small Cell Lung Carcinoma

Intervention

• Drug: pemetrexed
  500 mg/m2, IV q 21 days x 6 cycles
  Other Names:

  • LY231514
  • Alimta
• 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

Study Arms

• Experimental: A
  Interventions:

  • Drug: pemetrexed
  • Drug: cisplatin
• Active Comparator: B
  Interventions:

  • Drug: gemcitabine
  • Drug: cisplatin

Publications *

• Wu YL, Lu S, Cheng Y, Zhou C, Wang M, Qin S, Lu Y, Zhang Y, Zhu Y, Song X, Wang X, Barraclough H, Zhang X, Chi H, Orlando M. Efficacy and safety of pemetrexed/cisplatin versus gemcitabine/cisplatin as first-line treatment in Chinese patients with advanced nonsquamous non-small cell lung cancer. Lung Cancer. 2014 Sep;85(3):401-7. doi: 10.1016/j.lungcan.2014.07.007. Epub 2014 Jul 17.
• Gridelli C, Brodowicz T, Langer CJ, Peterson P, Islam M, Guba SC, Moore P, Visseren-Grul CM, Scagliotti G. Pemetrexed therapy in elderly patients with good performance status: analysis of two phase III trials of patients with nonsquamous non-small-cell lung cancer. Clin Lung Cancer. 2012 Sep;13(5):340-6. doi: 10.1016/j.cllc.2011.12.002. Epub 2012 Jan 23.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 16, 2008): 1713
• Original Enrollment: Not Provided
• Actual Study Completion Date: March 2008
• Actual Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Australia, Austria, Belgium, Brazil, Canada, Denmark, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Korea, Republic of, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States
• Removed Location Countries: China, Hong Kong, Pakistan, Singapore, Switzerland

Administrative Information

• NCT Number: NCT00087711
• Other Study ID Numbers: 2938; H3E-MC-JMDB ( Other Identifier: Eli Lilly and Company )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Clinical Study Report (CSR)
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• URL: https://vivli.org/

• Current Responsible Party: Eli Lilly and Company
• Original Responsible Party: Not Provided
• Current Study Sponsor: Eli Lilly and Company
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• 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

• PRS Account: Eli Lilly and Company
• Verification Date: September 2019