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COMPLETED Phase 3

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

NCT00409188 · View on ClinicalTrials.gov ↗

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

6 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00409188

The ClinicalTrials.gov registry entry for NCT00409188 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,513 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EMD Serono, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00409188 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00409188?

The interventions under investigation include: Placebo (DRUG), Tecemotide (L-BLP25) (BIOLOGICAL), Single low dose cyclophosphamide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00409188?

This trial is sponsored by EMD Serono, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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