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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 226
- Locations
- 1
- Primary Endpoint
- Best Overall Response
Study Overview
Brief Summary
To investigate efficacy and safety of pemetrexed as second or third line therapy in patients with non-small cell lung cancer (NSCLC).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Pemetrexed 500 mg/m2
Pemetrexed 500 mg/m2
Intervention: Pemetrexed 500 mg/m2 (Drug)
Pemetrexed 1000 mg/m2
Pemetrexed 1000 mg/m2
Intervention: Pemetrexed 1000 mg/m2 (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Duration of Response(time of response to progressive disease (up to 3.2 years))
- Progression-Free Survival (PFS)(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)(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)(Baseline (pre-dose), 3 Months after first dose of Cycle 1)