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Tecemotide Following Concurrent Chemo-radiotherapy for Non-small Cell Lung Cancer

NCT02049151 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2017-08-23

Study results available
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Summary

This is a multi-center, double-blind, placebo-controlled, randomized, Phase 3 trial in subjects with unresectable stage III non-small cell lung cancer (NSCLC) who have demonstrated either stable disease or objective response following primary concurrent chemo-radiotherapy (CRT), comparing overall survival (OS) time in subjects treated with tecemotide versus subjects treated with tecemotide-matching placebo.

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

Tecemotide

Tecemotide injection will be administered once weekly subcutaneously at a dose of 806 microgram up to Week 8 and from Week 14, every 6 weeks until end-of-trial, or until NSCLC progression.

DRUG

Placebo

Matching placebo injection will be administered once weekly subcutaneously up to Week 8 and from Week 14, every 6 weeks until end-of-trial, or until NSCLC progression.

DRUG

Cyclophosphamide (CPA)

CPA injection will be administered as a single intravenous infusion at a dose of 300 milligram per square meter (mg/m\^2) (to a maximum of 600 mg) 3 days before the first injection of tecemotide.

DRUG

Saline (sodium chloride)

Matching placebo (saline) injection will be administered as a single intravenous (0.9 percent \[%\] sodium chloride) infusion 3 days before the first injection of tecemotide-matching placebo.

Sponsors & Collaborators

Principal Investigators

  • Medical Responsible · Merck KGaA, Darmstadt, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States
  • Germany

Study Locations

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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 NCT02049151 on ClinicalTrials.gov