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NCT00409188 · ClinicalTrials.gov registry record · Phase 3

Cancer Vaccine Study for Unresectable Stage III Non-small Cell Lung Cancer (START)

A Phase 3 study of Non-Small Cell Lung Cancer, sponsored by EMD Serono.

Completed
Registry status
Phase 3
Development phase
1,513
Enrollment target
20
Study locations

NCT00409188 is a Phase 3 study of Non-Small Cell Lung Cancer that has completed, run by EMD Serono. The registered enrollment target is 1,513 participants, above the 656-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (131% higher). The trial reports 20 study locations across 8 states.

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The verdict

NCT00409188, a Phase 3 study of Non-Small Cell Lung Cancer, has completed, sponsored by EMD Serono.

COMPLETED
Registry status
Phase 3
Development phase
1,513 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to determine whether the cancer vaccine tecemotide (L-BLP25) in addition to best supportive care is effective in prolonging the lives of subjects with unresectable stage III non-small cell lung cancer, compared to best supportive care alone. A local ancillary (sub) study in European centers will evaluate the immune response in peripheral blood after tecemotide (L-BLP25) or placebo vaccination.

Conditions Studied

Interventions

  • DRUG Placebo
  • BIOLOGICAL Tecemotide (L-BLP25)
  • DRUG Single low dose cyclophosphamide

Study Locations (20)

California

  • Pacific Cancer Medical Center - Anaheim
  • Glendale Adventist Medical Center - Glendale
  • Norris Cancer Hospital - Los Angeles
  • Cedars-Sinai Outpatient Cancer Center at the Samuel Oschin Comprehensive Cancer Institute - Los Angeles
  • Clinical Trials and Research Associates, Inc. - Montebello
  • Desert Hematology Oncology Medical Group, Inc - Rancho Mirage
  • Stockton Hematology Oncology Medical Group, Inc. - Stockton

Florida

  • Pasco Hernando Oncology Associates P.A - Brooksville
  • University of Miami, Sylvester Comprehensive Cancer Center - Miami
  • Pasco Hernando Oncology Associates, PA - New Port Richey
  • Florida Hospital Memorial System - Ormond Beach

Illinois

  • Southern Illinois Hematology/Oncology - Centralia
  • Rush University Medical Center - Chicago
  • Joliet Oncology-Hematology Associates, Ltd. - Joliet

Louisiana

  • Leonard J. Chabert Medical Center - Houma
  • Hematology and Oncology Specialists, LLC - Metarie

Arkansas

  • Saint Edward Mercy Medical Center - Fort Smith

Colorado

  • University of Colorado Cancer Center - Denver

Kentucky

  • Kentucky Cancer Center - Hazard

Maryland

  • Sinai Hospital of Baltimore - Baltimore

Trial Details

FieldValue
Enrollment Target 1,513 participants
Start Date 2007-01
Est. Completion 2015-04
Phase Phase 3

Sponsor

EMD Serono

71 total trials

What the Registry Record Tells You About NCT00409188

The ClinicalTrials.gov registry entry for NCT00409188 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,513 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 656-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (131% higher). The listed sponsor is EMD Serono, which has 71 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT00409188 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Florida, Illinois.

Frequently Asked Questions

What is clinical trial NCT00409188 about?

NCT00409188 is a clinical study titled "Cancer Vaccine Study for Unresectable Stage III Non-small Cell Lung Cancer (START)". The purpose of this study is to determine whether the cancer vaccine tecemotide (L-BLP25) in addition to best supportive care is effective in prolonging the lives of subjects with unresectable stage III non-small cell lung cancer, compared to best supportive care alone. A local ancillary (sub) stud...

What is the current status of trial NCT00409188?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,513 participants. The study started on 2007-01. Estimated completion is 2015-04.

What conditions does trial NCT00409188 study?

This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.

What interventions are being tested in trial NCT00409188?

The interventions under investigation include: Placebo (DRUG), Tecemotide (L-BLP25) (BIOLOGICAL), Single low dose cyclophosphamide (DRUG).

Who is sponsoring clinical trial NCT00409188?

This trial is sponsored by EMD Serono, which has 71 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00409188 being conducted?

This trial has 20 study locations across Arkansas, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.