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Second-line Therapy Study of Combined Chemotherapy and Endostar to Patients With Non-Small Cell Lung Cancer(NSCLC)

NCT00813332 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2010-01-25

No results posted yet for this study

Summary

The purpose of this study is to compare the efficacy and safety of Endostar (Recombinant Human Endostatin) combined with Docetaxel and single Docetaxel through multi-center, double-blinding, randomized controlled, phase Ⅳ clinical trial for NSCLC cases who have obvious progressive disease or intolerant adverse effects in first-line chemotherapy.

Conditions

  • Advanced NSCLC
  • Recurrent NSCLC

Interventions

DRUG

Endostar(rh recombinant endostatin) plus Docetaxel

7.5mg/m2, IV( in the vein) on day1-14 of each 21-28 day cycle. Number of cycles: until progression or unacceptable toxicity develops.

DRUG

Placebo plus Docetaxel

Placebo plus Docetaxel

Sponsors & Collaborators

  • Simcere Pharmaceutical Co., Ltd

    lead OTHER

Principal Investigators

  • Kai LI, professor · Cancer Hospital of Tianjin Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-10-31
Completion
2010-10-31

Countries

  • China

Study Locations

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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 NCT00813332 on ClinicalTrials.gov