drugset / Trial / NCT00095199

Docetaxel or Pemetrexed With or Without Cetuximab in Patients With Recurrent or Progressive Non-Small Cell Lung Cancer

NCT00095199

Phase 3 Completed 939 enrolled Eli Lilly and Company
RandomizedParallel-groupOpen-labelTreatment

Summary

This trial is a multicenter, open-label, randomized, Phase III study in patients with recurrent or progressive Non-Small Cell Lung Cancer (NSCLC) after failure of an initial platinum-based chemotherapy. Patients will receive either Docetaxel or Pemetrexed as chemotherapy at the investigator's choice. Within each chemotherapy group, patients will be randomized to receive Cetuximab plus chemotherapy or chemotherapy alone (Cetuximab \& Pemetrexed or Pemetrexed alone; Cetuximab \& Docetaxel or Docetaxel alone).

Timeline

Start
2005-01
Primary completion
2011-07
Completion
2011-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody 250 mg/m2 Intravenous
Subject Docetaxel Small molecule 75 mg/m2 Intravenous
Subject Pemetrexed Small molecule 500 mg/m2 Intravenous