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Nimotuzumab Plus Docetaxel in Chemotherapy-Refractory/Resistant Patients With Advanced Non-Small-Cell Lung Cancer

NCT00983047 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-08-27

No results posted yet for this study

Summary

Nimotuzumab is a humanized monoclonal anti-body targeting the epidermal growth factor receptor (EGFR). Clinical trials are ongoing globally to evaluate nimotuzumab in different indications. Nimotuzumab has demonstrated a unique clinical profile, where anti-tumor activity was observed in absence of severe skin, renal, gastrointestinal mucosa toxicities commonly associated with EGFR-targeting antibodies. Nimotuzumab has been granted approval for use in squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal cancer in many countries. The investigators compared docetaxel plus nimotuzumab with docetaxel alone in chemotherapy-refractory/resistant patients with advanced EGFR-positive non-small-cell lung cancer to assess the efficacy and safety.

Conditions

Interventions

DRUG

Nimotuzumab and Docetaxel

The chemotherapy treatment:Docetaxel was administered every 3 weeks 75 mg/m2, efficacy will be evaluated after two cycles,the chemotherapy will be administered continually 2 cycles if the response is CR\\PR\\SD. No more than 4 cycles chemotherapy was given. Nimotuzumab treatment: Dose of 200 mg intravenous infusion per week was continued after the end of chemotherapy until disease progression or unacceptable toxicity.

Sponsors & Collaborators

  • Biotech Pharmaceutical Co., Ltd.

    lead OTHER

Principal Investigators

  • Jie Wang · Peking University Cancer Hospital & Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-08-31
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 NCT00983047 on ClinicalTrials.gov