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
Phase 3
Completed
- Conditions
- Non Small Cell Lung Carcinoma
- Interventions
- Registration Number
- NCT00087711
- Lead Sponsor
- Eli Lilly and Company
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1713
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A pemetrexed - B cisplatin - A cisplatin - B gemcitabine -
- Primary Outcome Measures
Name Time Method Overall survival baseline to date of death from any cause
- Secondary Outcome Measures
Name Time Method Progression free survival baseline to measured progressive disease Time to progressive disease baseline to measured progressive disease Duration of response time of response to progressive disease Time to treatment failure baseline to stopping treatment
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
🇬🇧Sutton, United Kingdom