At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 1/2 Study of Pemetrexed (Alimta) Plus Carboplatin, or Pemetrexed Plus Cisplatin With Concurrent Radiation Therapy Followed by Every-21-Day Pemetrexed Consolidation in Patients With Favorable-Prognosis Inoperable Stage IIIA/B Non-Small-Cell Lung Cancer (NSCLC)
In Brief
A Phase 2 clinical trial evaluating pemetrexed, cisplatin, and 2 other interventions for Non-Small-Cell Lung Cancer. Completed, enrolled 120 participants across 11 sites in 2 countries.
Detailed Summary
The primary purpose of this study is to determine the 2-year survival rate of both of the chemotherapy regimens in patients with inoperable non-small-cell lung cancer.
Study Details
Timeline
Interventions
Phase 1 - 500 milligram/meter squared (mg/m²), administered intravenously, every 21 days for 3 cycles Phase 2 - 500 mg/m², administered intravenously, every 21 days for 3 cycles Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation therapy for each phase
Phase 1 - 30 mg/m² and 75 mg/m², administered intravenously, Days 1, 8, 22, 29 and 43 Phase 2 - 75 mg/m², administered intravenously, every 21 days for 3 cycles
Phase 1 - dosed at area under the curve (AUC) 2 milligram/milliliter\*minute (mg/mL\*min), administered intravenously, Days 1, 8, 22, 29 and 43 Phase 2 - dosed at AUC 5 mg/mL\*min, administered intravenously, every 21 days for 3 cycles
Phase 1 - 2 Gray, daily, 5 days a week for Days 1-51 Phase 2 - 2 Gray, daily, 5 days a week for Days 1-45