NCT00828841

Phase 2b Study of Cetuximab With Platinum-Based Chemo as First Line Treatment of Recurrent or Advanced NSCLC

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 601 (actual)
• Sponsor: Accelerated Community Oncology Research Network · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Cetuximab	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.
DRUG	Paclitaxel	Paclitaxel 200 mg/m2 Day 1 every 21 days
DRUG	Carboplatin	Carboplatin AUC 6 Day 1 every 21 days
DRUG	Gemcitabine	Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days
DRUG	Cisplatin	Cisplatin 75 mg/m2 Day I every 21 days

Timeline

• Start date: 2008-12-01
• Primary completion: 2012-07-01
• Completion: 2012-08-01
• First posted: 2009-01-26
• Last updated: 2013-11-06
• Results posted: 2013-10-11

Locations

84 sites across 1 country: United States