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

NCT00828841 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 601

Last updated 2013-11-06

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • Accelerated Community Oncology Research Network

    lead OTHER

Principal Investigators

  • Lee Schwartzberg, MD, FACP · Accelerated Community Oncology Research Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2012-07-31
Completion
2012-08-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT00828841 on ClinicalTrials.gov