Non Small Cell Lung Carcinoma
Conditions
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.
Interventions
DRUGpemetrexed
500 mg/m2, IV q 21 days x 6 cycles
DRUGgemcitabine
1250 mg/m2, IV, day 1 and 8 q 21 days x 6 cycles
DRUGcisplatin
75 mg/m2, IV, q 21 days x 6 cycles
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | baseline to date of death from any cause |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Denmark, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Mexico, Netherlands, Poland, Portugal, Puerto Rico, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom, United States
Outcome results
None listed