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Cancer Immunotherapy GSK1572932A as Adjuvant Therapy for Patients With Tumor-antigen-positive Non-Small Cell Lung Cancer

NCT00455572 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2017-05-15

No results posted yet for this study

Summary

The purpose of this clinical trial is to find out how successfully non-small-cell lung cancer patients are able to give an immune response to injections of the immunotherapeutic product GSK1572932A, and to find out more about the safety of this treatment. A course of eight injections will be administered over 21 weeks; including screening for suitability and all tests, the duration of the study for a patient will be 30-35 weeks. During this period various tests will be performed, including physical examinations and blood tests. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

  • Lung Cancer, Non-Small Cell

Interventions

BIOLOGICAL

Immunotherapeutic GSK1572932A

Intramuscular injection, 8 doses

DRUG

Cisplatin (CDDP)

Four cycles with doses based on patient's body surface area, intravenous administration

DRUG

Vinorelbine

Four cycles with doses based on patient's body surface area , intravenous administration

PROCEDURE

Radiotherapy

Regimen will be based upon the site's own standard procedures

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-11
Primary Completion
2013-08-04
Completion
2013-08-08

Countries

  • Belgium
  • Canada
  • France
  • Germany
  • Italy
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT00455572 on ClinicalTrials.gov