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Cisplatin and Gemcitabine With or Without Bevacizumab in EGFR Wild-type Non-Small Cell Lung Cancer

NCT01623102 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2013-02-12

No results posted yet for this study

Summary

Advanced non-small-cell lung cancer (NSCLC) patients without epidermal growth factor receptor (EGFR) mutations show a poor prognosis. Gemcitabine combined with cisplatin chemotherapy is an effective treatment measures for EGFR mutation-negative NSCLC patients, but the prognosis remains poor. Chemotherapy combined with targeted monoclonal antibody treatment may be better treatment options in these patients. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Bevacizumab blocks the ability of tumors to grow new blood vessels and spread. It is not yet known whether cisplatin and gemcitabine is more effective when given alone or with bevacizumab. This randomized trial studies how well giving cisplatin and gemcitabine alone or in combination with Bevacizumab (Avastin) works in treating patients with stage IIIB/IV non-squamous NSCLC without EGFR mutations.

Conditions

Interventions

DRUG

cisplatin and gemcitabine combination with Bevacizumab

Patients receive gemcitabine and cisplatin chemotherapy combined with Bevacizumab every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Gemcitabine 1250mg/m2 d1, d8, cisplatin 75mg/m2 d1, Bevacizumab 7.5 mg / kg every 21 days.

DRUG

Gemcitabine combined with cisplatin chemotherapy

Patients receive gemcitabine combined with cisplatin chemotherapy every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Gemcitabine 1250mg/m2 d1, d8, + cisplatin 75mg/m2 d1.

Sponsors & Collaborators

  • Sichuan Cancer Hospital and Research Institute

    lead OTHER

Principal Investigators

  • juan li, MD · Sichuan Cancer Hospital and Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2014-08-31
Completion
2014-12-31

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 NCT01623102 on ClinicalTrials.gov