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

Study Overview
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Brief Summary
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To investigate efficacy and safety of pemetrexed as second or third line therapy in patients with non-small cell lung cancer (NSCLC).

Official Title
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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

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Pemetrexed 500 mg/m2
* Drug: Pemetrexed 1000 mg/m2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pemetrexed 500 mg/m2<br>Pemetrexed 500 mg/m2 | Drug: Pemetrexed 500 mg/m2<br>* 500 mg/m2, intravenous (IV), every 21 days, one year from registration date<br>* Other names: LY231514;|
| Experimental: Pemetrexed 1000 mg/m2<br>Pemetrexed 1000 mg/m2 | Drug: Pemetrexed 1000 mg/m2<br>* 1000 mg/m2, intravenous (IV), every 21 days, one year from registration date<br>* Other names: LY231514;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Overall Response | 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. | baseline to measured progressive disease (up to 3.2 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Response | 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. | time of response to progressive disease (up to 3.2 years) | 
| Progression-Free Survival (PFS) | 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. | baseline to measured progressive disease (up to 3.2 years) | 
| Change From Baseline to 3 Months in Quality of Life Questionnaire for Cancer Patients Treated With Anticancer Drugs (QOL-ACD) | 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. | Baseline (pre-dose), 3 Months after first dose of Cycle 1 | 
| Change From Baseline to 3 Months in Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) Lung Cancer Subscale (LCS) | 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. | Baseline (pre-dose), 3 Months after first dose of Cycle 1 |