drugset / Trial / NCT00269152

Feasibility Study of Pemetrexed in Combination With Cisplatin or Carboplatin as Adjuvant Treatment of Non-Small Cell Lung Cancer

NCT00269152 ↗

Phase 2 Completed 122 enrolled Eli Lilly and Company
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is a multicenter, open-label, two-arm, randomized, parallel Phase 2 feasibility study of pemetrexed in combination with either cisplatin (Arm A) or carboplatin (Arm B) as adjuvant combination-chemotherapy in participants with completely resected, stage Ib or IIa/IIb non-small cell lung cancer (NSCLC). A two-stage design will be employed independently for both treatment arms, with the possibility of stopping each treatment early for lack of feasibility.

Timeline

Start
2005-12
Primary completion
2007-11
Completion
2013-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 5 unknown Intravenous
Subject Cisplatin Other / unclassified 75 mg/m2 Intravenous
Background Pemetrexed Small molecule 500 mg/m2 Intravenous