To Investigate Efficacy and Safety of Pemetrexed as Second or Third Line Therapy in Patients With Non-small Cell Lung Cancer (NSCLC)

• ClinicalTrials.gov Identifier: NCT00191191
• Recruitment Status: Completed
• First Posted: September 19, 2005
• Results First Posted: November 25, 2009
• Last Update Posted: December 9, 2009
• Sponsor: Eli Lilly and Company
• Information provided by: Eli Lilly and Company

Tracking Information

• First Submitted Date: September 12, 2005
• First Posted Date: September 19, 2005
• Results First Submitted Date: October 23, 2009
• Results First Posted Date: November 25, 2009
• Last Update Posted Date: December 9, 2009
• Study Start Date: October 2004
• Actual Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 4, 2009)

Best Overall Response [ Time Frame: baseline to measured progressive disease (up to 3.2 years) ]

Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria as determined by the Case Judgment Committee. Best overall response was defined as the most favorable overall response recorded for each patient during the observation period. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.

• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: October 23, 2009)

• Duration of Response [ Time Frame: time of response to progressive disease (up to 3.2 years) ]
  The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression.
• Progression-Free Survival (PFS) [ Time Frame: baseline to measured progressive disease (up to 3.2 years) ]
  PFS was defined as time from the scheduled date of the first treatment cycle until the date of confirmation of progressive disease on the overall response rating. For patients who died before confirmation of progressive disease, the number of days until the date of death (from any cause) was handled as progression-free survival.
• Change From Baseline to 3 Months in Quality of Life Questionnaire for Cancer Patients Treated With Anticancer Drugs (QOL-ACD) [ Time Frame: Baseline (pre-dose), 3 Months after first dose of Cycle 1 ]
  20-items assessed quality of life in patients undergoing chemotherapy. Scores range from 1 (not at all/very poor) to 5 (very much/very well). Face scale scores (patient circles number of the face that best fits his/her feelings) range from 1 (sad face) to 5 (smiling face). Item scores were grouped according to Functional (daily activity: 5 items), Physical (5 items), Emotional (psychological condition: 4 items), Social Attitude (5 items), and Face Scale (1 item). Score of subscales were converted to scores with range from 0 to 100. Higher scores represent higher QOL.
• Change From Baseline to 3 Months in Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) Lung Cancer Subscale (LCS) [ Time Frame: Baseline (pre-dose), 3 Months after first dose of Cycle 1 ]
  FACT-L LCS measured health-related quality of life (HR-QL) related to additional concerns of lung cancer. Original LCS subscale scores range from 0 to 28, but the scores were converted to scores with a range of 0 to 100 in this study. Higher scores represent better HR-QL.

• 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: To Investigate Efficacy and Safety of Pemetrexed as Second or Third Line Therapy in Patients With Non-small Cell Lung Cancer (NSCLC)
• Official Title: LY231514 500 mg/m2 and LY231514 1000 mg/m2 in Patients With Advanced Non-Small Cell Lung Cancer Who Were Previously Treated With Prior Systemic Anti Cancer Therapy: A Randomized Phase II Trial
• Brief Summary: To investigate efficacy and safety of pemetrexed as second or third line therapy in patients with non-small cell lung cancer (NSCLC).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Non-small Cell Lung Cancer

Intervention

• Drug: Pemetrexed 500 mg/m2
  500 mg/m2, intravenous (IV), every 21 days, one year from registration date
  Other Names:

  • Alimta
  • LY231514
• Drug: Pemetrexed 1000 mg/m2
  1000 mg/m2, intravenous (IV), every 21 days, one year from registration date
  Other Names:

  • Alimta
  • LY231514

Study Arms

• Experimental: Pemetrexed 500 mg/m2
  Pemetrexed 500 mg/m2
  Intervention: Drug: Pemetrexed 500 mg/m2
• Experimental: Pemetrexed 1000 mg/m2
  Pemetrexed 1000 mg/m2
  Intervention: Drug: Pemetrexed 1000 mg/m2

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 6, 2008): 226
• Original Enrollment: Not Provided
• Actual Study Completion Date: October 2008
• Actual Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Clinical stage III or IV
• Previously treated with one or two chemotherapeutic regimens
• Performance status: 0-2

Exclusion Criteria:

- Inability or unwillingness to take folic acid or vitamin B12 supplementation

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT00191191
• Other Study ID Numbers: 5250; H3E-JE-NS01 ( Other Identifier: Eli Lilly and Company )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Chief Medical Officer, Eli Lilly
• Study Sponsor: Eli Lilly and Company
• Collaborators: Not Provided

Investigators

• Study Director: Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time(UTC/GMT - 5 hours, EST); Eli Lilly and Company

• PRS Account: Eli Lilly and Company
• Verification Date: December 2009