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Trial of an RNActive®-Derived Cancer Vaccine in Stage IIIB/IV Non Small Cell Lung Cancer (NSCLC)

NCT00923312 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2018-03-20

No results posted yet for this study

Summary

This is a phase I/IIa open, uncontrolled, international, prospective clinical trial, in an out-patient setting, in patients with stage IIIB/IV NSCLC.

The phase I part of the study consists of a dose escalation phase, in which the recommended dose (RD) for the phase IIa part of the study will be established based on the incidence of dose-limiting toxicities (DLT). In the phase IIa part of the study, additional patients will be included at the RD, to confirm the safety and explore the activity of that dose.

This study will take place in Switzerland (2 sites) and Germany (11 sites).

Conditions

  • Non Small Cell Lung Cancer

Interventions

BIOLOGICAL

CV9201

CV9201 is a vaccine consisting of five drug product components. Treatment will be administered on 5 timepoints.

Sponsors & Collaborators

  • CureVac

    lead INDUSTRY

Principal Investigators

  • Alexander Knuth, Prof. Dr. · Universitätsspital Zürich

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2012-02-29
Completion
2014-05-31

Countries

  • Germany
  • Switzerland

Study Locations

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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 NCT00923312 on ClinicalTrials.gov