MedTrace Logo

Study of Taxane/Carboplatin +/- Cetuximab as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer

NCT00112294 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 755

Last updated 2015-12-24

Study results available
· View outcomes & findings →

Summary

The primary purpose of this clinical research study is to learn if patients treated with the combination of Taxane/Carboplatin plus Cetuximab (C/T/C) have a longer progression-free survival than patients treated with Taxane/Carboplatin (T/C) alone. The safety of this treatment will also be studied.

Conditions

  • Non-Small-Cell Lung Carcinoma

Interventions

DRUG

Paclitaxel (Taxane)

IV, 225 mg/m\^2

DRUG

Docetaxel (Taxane)

IV, 75 mg/m\^2

DRUG

Carboplatin

AUC=6, q 3 weeks (6 cycles maximum)

DRUG

Cetuximab

Intravenous, 400 mg/m\^2, initial dose followed by 250 mg/m\^2, weekly starting on Week 2

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2007-04-30
Completion
2008-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00112294 on ClinicalTrials.gov