Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01383148 · ClinicalTrials.gov registry record · Phase 2
Phase IIB/III Of TG4010 Immunotherapy In Patients With Stage IV Non-Small Cell Lung Cancer
A Phase 2 study, sponsored by Transgene.
- Terminated
- Registry status
- Phase 2
- Development phase
- 222
- Enrollment target
NCT01383148 is a Phase 2 study that was terminated before completion, run by Transgene. The registered enrollment target is 222 participants.
The verdict
NCT01383148, a Phase 2 study, was terminated before completion, sponsored by Transgene.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 222 participants
- Enrollment target
Study Summary
This is a Phase IIb/III randomized, double-blind, placebo-controlled study to compare the efficacy and safety of first-line therapy combined with TG4010 or placebo in stage IV non-small cell lung cancer (NSCLC). TG4010 is a suspension of recombinant Modified Vaccinia virus strain Ankara (MVA strain) carrying coding sequences for human MUC1 antigen and human interleukin-2 (IL2). TG4010 has been developed for use as an immunotherapy in cancer patients whose tumors express the MUC1 antigen. TG4010 is intended to induce a MUC1-specific cellular immune response and to produce a non-specific activation of several components of the immune system.
Interventions
- DRUG placebo
- BIOLOGICAL TG4010
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 222 participants |
| Start Date | 2012-04 |
| Est. Completion | 2016-07 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01383148
The ClinicalTrials.gov registry entry for NCT01383148 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 222 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Transgene, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01383148 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01383148 about?
NCT01383148 is a clinical study titled "Phase IIB/III Of TG4010 Immunotherapy In Patients With Stage IV Non-Small Cell Lung Cancer". This is a Phase IIb/III randomized, double-blind, placebo-controlled study to compare the efficacy and safety of first-line therapy combined with TG4010 or placebo in stage IV non-small cell lung cancer (NSCLC). TG4010 is a suspension of recombinant Modified Vaccinia virus strain Ankara (MVA strain...
What is the current status of trial NCT01383148?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 222 participants. The study started on 2012-04. Estimated completion is 2016-07.
What interventions are being tested in trial NCT01383148?
The interventions under investigation include: placebo (DRUG), TG4010 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01383148?
This trial is sponsored by Transgene, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
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.