Trial · NCT01345669
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
NCT01345669, Phase 3, Terminated, Boehringer Ingelheim; results first posted 2017-10-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT01345669. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01345669
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT01345669
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 617 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Head and Neck Neoplasms
- Interventions
- Placebo, Afatinib
- First posted
- 2011-05-02
- Last updated
- 2017-12-07
- Other registries' IDs
- eudract:2011-000392-14
- Results first posted
- 2017-10-23
- Limitations and caveats
- The trial was stopped prematurely due to futility.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease Free Survival (DFS) | Up to 5 years | 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. |
| Secondary | Disease Free Survival (DFS) Rate at 2 Years | Up to 2 years | Disease Free Survival (DFS) rate at 2 years. Probability of being disease free at 2 years in percentage is provided based on Kaplan-Meier method. |
| Secondary | Percentage of Patient Deaths (Overall Survival (OS)) | Up to 5 years | Overall survival (OS), defined as the time from randomisation until death (regardless of cause). Due to the small event rate in both treatment arms caused by the early termination of the trial, the hazard estimate is not interpretable. Hence presented the total randomized and the percentage of patients died. |
| Secondary | Patients With Improved Health Related Quality of Life (HRQOL) | Up to 5 years | HRQoL questionnaires focused on 3 scales: Pain scale from H\&N35, Swallowing scale from H\&N35 and Global health status/QoL scale from C30. Improvement was defined as a score that improved from baseline by at least 10 points (on the 0-100 point scale) at any time during the study. If a patient had not improved, worsening was defined as a 10-point worsening at any time during the study. Patients who had neither improved nor worsened were considered as stable. Percentages of patients with improvement in HRQoL are presented. |
| Secondary | Time to Deterioration in Health Related Quality of Life (HRQOL) | Up to 5 years | HRQoL questionnaires focused on 3 scales: Pain scale from H\&N35, Swallowing scale from H\&N35 and Global health status/QoL scale from C30. Time to deterioration was defined as the time from randomisation to the first 10-point worsening on the 0-100 point scale. Patients with no deterioration (including those with disease recurrence/SPT) were censored at the last available HRQoL assessment date. Patients with no post-baseline assessments were censored on the day of randomisation. |
| Secondary | Health Related Quality of Life (HRQOL) Scores Over Time | Baseline and 5 years | HRQoL questionnaires focused on 3 scales: Pain scale from H\&N35, Swallowing scale from H\&N35 and Global health status/QoL scale from C30. Scoring of the symptom scales/items followed the European Organisation for Research and Treatment of Cancer (EORTC) scoring manual and a linear transformation of the scores to a 0-100 point scale. Higher values are better. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease Free Survival (DFS) | Up to 5 years | Randomised Set (RS): Included all patients who were randomised, regardless of taking investigational treatment (as randomised) | Months | MEDIAN |
| SECONDARY | Disease Free Survival (DFS) Rate at 2 Years | Up to 2 years | Randomised Set, the number of patients from the randomized set those are disease free (or DFS) at 2 years. | Probability (%) | NUMBER |
| SECONDARY | Percentage of Patient Deaths (Overall Survival (OS)) | Up to 5 years | Randomised Set (RS): Included all patients who were randomised, regardless of taking investigational treatment (as randomised) | Percentage of patients | NUMBER |
| SECONDARY | Patients With Improved Health Related Quality of Life (HRQOL) | Up to 5 years | Randomised Set (RS): Included all patients who were randomised, regardless of taking investigational treatment (as randomised) | Percentage of Patients | NUMBER |
| SECONDARY | Time to Deterioration in Health Related Quality of Life (HRQOL) | Up to 5 years | Randomised Set (RS): Included all patients who were randomised, regardless of taking investigational treatment (as randomised) | Months | MEDIAN |
| SECONDARY | Health Related Quality of Life (HRQOL) Scores Over Time | Baseline and 5 years | Randomised Set (RS): Included all patients who were randomised, regardless of taking investigational treatment (as randomised) | Unit on Scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease Free Survival (DFS) | Afatinib (BIBW 2992) | 43.40 | Inter-Quartile Range 16.82 to NA | Months | |
| Disease Free Survival (DFS) | Placebo | NA | Inter-Quartile Range 16.69 to NA | Months | |
| Disease Free Survival (DFS) Rate at 2 Years | Afatinib (BIBW 2992) | 67.2 | 95% Confidence Interval 61.2 to 72.5 | Probability (%) | |
| Disease Free Survival (DFS) Rate at 2 Years | Placebo | 73.5 | 95% Confidence Interval 66.0 to 79.5 | Probability (%) | |
| Percentage of Patient Deaths (Overall Survival (OS)) | Afatinib (BIBW 2992) | 15.1 | 16.82 to NA | Percentage of patients | |
| Percentage of Patient Deaths (Overall Survival (OS)) | Placebo | 11.2 | 16.69 to NA | Percentage of patients | |
| Patients With Improved Health Related Quality of Life (HRQOL) | Afatinib (BIBW 2992) | Swallowing (Q5-Q8 from QLQ-HN35) | 34.8 | 16.82 to NA | Percentage of Patients |
| Patients With Improved Health Related Quality of Life (HRQOL) | Placebo | Swallowing (Q5-Q8 from QLQ-HN35) | 27.2 | 16.69 to NA | Percentage of Patients |
| Patients With Improved Health Related Quality of Life (HRQOL) | Afatinib (BIBW 2992) | Pain HN35 (Q1-Q4 from QLQ-HN35) | 33.8 | Percentage of Patients | |
| Patients With Improved Health Related Quality of Life (HRQOL) | Placebo | Pain HN35 (Q1-Q4 from QLQ-HN35) | 26.2 | Percentage of Patients |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Afatinib (BIBW 2992) | 411 | |
| Overall Study | STARTED | Placebo | 206 | |
| Overall Study | COMPLETED | Afatinib (BIBW 2992) | 124 | |
| Overall Study | COMPLETED | Placebo | 87 | |
| Overall Study | NOT COMPLETED | Afatinib (BIBW 2992) | 287 | |
| Overall Study | NOT COMPLETED | Placebo | 119 |
Source ClinicalTrials.gov
Adverse events350
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Afatinib (BIBW 2992) | 23 | 411 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 7 | 206 | |
| other | Abdominal pain | Gastrointestinal disorders | Afatinib (BIBW 2992) | 21 | 411 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 6 | 206 | |
| other | Cheilitis | Gastrointestinal disorders | Afatinib (BIBW 2992) | 22 | 411 | |
| other | Cheilitis | Gastrointestinal disorders | Placebo | 1 | 206 | |
| other | Constipation | Gastrointestinal disorders | Afatinib (BIBW 2992) | 33 | 411 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 20 | 206 | |
| other | Diarrhoea | Gastrointestinal disorders | Afatinib (BIBW 2992) | 335 | 411 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 41 | 206 |
1 to 10 of 350Source ClinicalTrials.gov
See all 350 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Afatinib (BIBW 2992) | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Afatinib (BIBW 2992) | 407 | 411 |
| Total, other adverse events | Placebo | 169 | 206 |
| Total, serious adverse events | Afatinib (BIBW 2992) | 80 | 411 |
| Total, serious adverse events | Placebo | 51 | 206 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Afatinib (BIBW 2992) vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01345669
GET https://conductscience.org/api/trials/v1/NCT01345669/results?page=2