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: Clinical Trial Phase 2 study, sponsored by Transgene.
NCT01383148 is a Phase 2 study that was terminated before completion, run by Transgene. The registered enrollment target is 222 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PFS is measured from date of randomization to radiographically documented progression according to RECIST 1.1 or death from any cause (whichever occurs first). Participants alive and without disease progression or lost to follow-up will be censored at the date of their last radiographic assessment.
Interventions
- DRUG placebo
- BIOLOGICAL TG4010
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 222 participants |
| Start Date | 2012-04 |
| Est. Completion | 2016-07 |
| Phase | Phase 2 |
Why NCT01383148 stopped before completion
NCT01383148 is an interventional study that assigns participants to a tested intervention. The registered 222 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% higher).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01383148 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT01383148's enrollment target sits among peer trials
222 274th of 2000 higher than 1,726 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04939610 · 222 participants · Phase 1
A Study of 177Lu-FAP-2286 in Advanced Solid Tumors
- NCT05424783 · 222 participants
MRI And GPS Informing Choices for Prostate Cancer Treatment (MAGIC)
- NCT05568264 · 222 participants · NA
Effects of a Physical Therapy Intervention on Motor Delay in Infants Admitted to a Neonatal Intensive Care Unit
- NCT05605574 · 222 participants · NA
Longitudinal Early Advance Care Planning Discussions and Documentation (LEADD) Program: An Exploratory Study in Adolescents and Young Adults (AYAs) Receiving Hematopoietic Stem Cell Transplant
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia