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Nimotuzumab in Combination With Cisplatin and Docetaxel for Patients With Advanced Non-small Cell Lung Cancer

NCT00985998 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2015-08-19

No results posted yet for this study

Summary

Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. The study assessed the safety, and efficacy of the combination of Nimotuzumab administered concomitantly with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC).

Conditions

Interventions

DRUG

Nimotuzumab and chemotherapy

The chemotherapy treament：docetaxel( 75mg/m2/d,every21days,for4\~6cycles) and cisplatin(total dose 75mg/m2 on day 2,3,4,every21days,for4\~6cycles). the nimotuzumab treatment:3 levels (200mg/w,400mg/w,600mg/w,weekly,for12\~18 weeks).

Sponsors & Collaborators

  • Biotech Pharmaceutical Co., Ltd.

    lead OTHER

Principal Investigators

  • Yuankai Shi, Professor · 86-10-87788121

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT00985998 on ClinicalTrials.gov