At a glance
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A Multi-Center Randomized Phase 2b Study of Cetuximab (Erbitux) in Combination With Platinum-Based Chemotherapy as First Line Treatment of Patients With Recurrent or Advanced Non-Small Cell Lung Cancer (NSCLC)
In Brief
A Phase 2 clinical trial evaluating Cetuximab, Paclitaxel, and 3 other interventions for Non-Small Cell Lung Cancer. Completed, enrolled 601 participants across 84 sites.
Detailed Summary
This study is testing the investigational drug, cetuximab, in combination with different chemotherapy drugs for lung cancer. The aim of the study is to determine which of the drug combinations looks most promising and should be tested further. The study will also look at what side effects may occur.
Study Details
Timeline
Interventions
Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.
Paclitaxel 200 mg/m2 Day 1 every 21 days
Carboplatin AUC 6 Day 1 every 21 days
Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days
Cisplatin 75 mg/m2 Day I every 21 days