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NCT01345682 · ClinicalTrials.gov registry record · Phase 3
LUX-Head&Neck 1: A Phase III Trial of Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic (R/M) Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 483
- Enrollment target
NCT01345682: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT01345682 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 483 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01345682, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 483 participants
- Enrollment target
Study Summary
This randomised, open-label, phase III study will be performed in patients with R/M head and neck squamous cell carcinoma (HNSCC) who have progressed after platinum-based therapy. The objectives of the trial are to compare the efficacy and safety of afatinib versus methotrexate
Primary Outcome
PFS was defined as the time from the date of randomisation to disease progression or death, whichever occurred first. The primary analysis of PFS considered PFS events as assessed by central independent review, including all data collected until the study completion date (06 December 2016). The date of disease progression was recorded based on RECIST version 1.1. Unequivocal progression of disease was determined if at least one of the following criteria applied: * At least 20% increase in the
Interventions
- DRUG Afatinib
- DRUG Methotrexate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 483 participants |
| Start Date | 2012-01-05 |
| Est. Completion | 2016-12-06 |
| Phase | Phase 3 |
What the finished NCT01345682 record still lists
NCT01345682 is an interventional study that assigns participants to a tested intervention. The registered 483 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 (37% lower).
The record links to 0 conditions, and to 2 interventions - of which Afatinib is the first listed.
NCT01345682 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01345682 about?
NCT01345682 is a clinical study titled "LUX-Head&Neck 1: A Phase III Trial of Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic (R/M) Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy". This randomised, open-label, phase III study will be performed in patients with R/M head and neck squamous cell carcinoma (HNSCC) who have progressed after platinum-based therapy. The objectives of the trial are to compare the efficacy and safety of afatinib versus methotrexate
What is the current status of trial NCT01345682?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 483 participants. The study started on 2012-01-05. Estimated completion is 2016-12-06.
What interventions are being tested in trial NCT01345682?
The interventions under investigation include: Afatinib (DRUG), Methotrexate (DRUG).
Who is sponsoring clinical trial NCT01345682?
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 NCT01345682's enrollment target sits among peer trials
483 792nd of 2000 higher than 1,209 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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