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NCT01345669 · ClinicalTrials.gov registry record · Phase 3
LUX-Head&Neck 2: A Phase III Trial of Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Terminated
- Registry status
- Phase 3
- Development phase
- 617
- Enrollment target
NCT01345669: Clinical Trial Phase 3 study, sponsored by Boehringer Ingelheim.
NCT01345669 is a Phase 3 study that was terminated before completion, run by Boehringer Ingelheim. The registered enrollment target is 617 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01345669, a Phase 3 study, was terminated before completion, sponsored by Boehringer Ingelheim.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 617 participants
- Enrollment target
Study Summary
This randomised, double-blind phase III trial will be performed in patients with head and neck squamous cell carcinoma (HNSCC). The objectives of the trial are to compare the efficacy and safety of afatinib (BIBW 2992) with placebo as adjuvant therapy to patients who have received definitive chemo-radiotherapy.
Primary Outcome
Disease Free Survival defined as the time from randomisation until documented tumour recurrence/ second primary tumour (SPT) or death from any cause, whichever occurred first.
Interventions
- DRUG Placebo
- DRUG Afatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 617 participants |
| Start Date | 2011-10-17 |
| Est. Completion | 2016-09-12 |
| Phase | Phase 3 |
Why NCT01345669 stopped before completion
NCT01345669 is an interventional study that assigns participants to a tested intervention. The registered 617 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01345669 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01345669 about?
NCT01345669 is a clinical study titled "LUX-Head&Neck 2: A Phase III Trial of Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy". This randomised, double-blind phase III trial will be performed in patients with head and neck squamous cell carcinoma (HNSCC). The objectives of the trial are to compare the efficacy and safety of afatinib (BIBW 2992) with placebo as adjuvant therapy to patients who have received definitive chemo-r...
What is the current status of trial NCT01345669?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 617 participants. The study started on 2011-10-17. Estimated completion is 2016-09-12.
What interventions are being tested in trial NCT01345669?
The interventions under investigation include: Placebo (DRUG), Afatinib (DRUG).
Who is sponsoring clinical trial NCT01345669?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01345669's enrollment target sits among peer trials
617 592nd of 2000 higher than 1,408 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
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