CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 601 enrolled
Drug / intervention
Cetuximab +4 moredrug
Likely dose
Cetuximab 400 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00828841
NCT00828841Phase 2Completed

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)

Accelerated Community Oncology Research Network·interventional·Posted Jan 26, 2009·Updated Nov 6, 2013

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 26, 2009
Enrollment StartDec 1, 2008
Primary CompletionJul 1, 2012
Study CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 17.4 years ago

Interventions

Cetuximabdrug

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.

Paclitaxeldrug

Paclitaxel 200 mg/m2 Day 1 every 21 days

Carboplatindrug

Carboplatin AUC 6 Day 1 every 21 days

Gemcitabinedrug

Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days

Cisplatindrug

Cisplatin 75 mg/m2 Day I every 21 days