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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

Primary Purpose

Head and Neck Neoplasms

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Afatinib
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  1. Histologically or cytologically confirmed loco-regionally advanced head and neck squamous cell carcinoma (HNSCC), stage III to IVb
  2. Unresected tumour prior to chemo-radiotherapy (CRT)
  3. Concomitant CRT completed prior to randomisation
  4. After concomitant platinum-based CRT, no evidence of disease (NED) on clinical and radiographic examinations
  5. Eastern cooperative oncology group (ECOG) performance status 0 or 1

Exclusion criteria:

  1. Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules, EGFR-targeted antibodies, and/or any investigational agents for HNSCC
  2. Patients with smoking history of less than or equal to 10 pack years and with primary tumour site of base of tongue and/or tonsil
  3. Any other malignancy (except for simultaneous HNSCC primaries, appropriately treated superficial basal cell skin cancer and surgically cured cervical cancer in situ) unless free of disease for at least five years
  4. Known pre-existing Interstitial Lung Disease (ILD)
  5. Pregnancy or breast feeding

Sites / Locations

  • 1200.131.00171 Boehringer Ingelheim Investigational Site
  • 1200.131.00181 Boehringer Ingelheim Investigational Site
  • 1200.131.00177 Boehringer Ingelheim Investigational Site
  • 1200.131.00185 Boehringer Ingelheim Investigational Site
  • 1200.131.00173 Boehringer Ingelheim Investigational Site
  • 1200.131.00176 Boehringer Ingelheim Investigational Site
  • 1200.131.00182 Boehringer Ingelheim Investigational Site
  • 1200.131.00175 Boehringer Ingelheim Investigational Site
  • 1200.131.00179 Boehringer Ingelheim Investigational Site
  • 1200.131.00188 Boehringer Ingelheim Investigational Site
  • 1200.131.10200 Boehringer Ingelheim Investigational Site
  • 1200.131.00172 Boehringer Ingelheim Investigational Site
  • 1200.131.00184 Boehringer Ingelheim Investigational Site
  • 1200.131.00198 Boehringer Ingelheim Investigational Site
  • 1200.131.00183 Boehringer Ingelheim Investigational Site
  • 1200.131.05451 Boehringer Ingelheim Investigational Site
  • 1200.131.05457 Boehringer Ingelheim Investigational Site
  • 1200.131.05458 Boehringer Ingelheim Investigational Site
  • 1200.131.05452 Boehringer Ingelheim Investigational Site
  • 1200.131.05453 Boehringer Ingelheim Investigational Site
  • 1200.131.06151 Boehringer Ingelheim Investigational Site
  • 1200.131.04353 Boehringer Ingelheim Investigational Site
  • 1200.131.04357 Boehringer Ingelheim Investigational Site
  • 1200.131.04355 Boehringer Ingelheim Investigational Site
  • 1200.131.04351 Boehringer Ingelheim Investigational Site
  • 1200.131.04359 Boehringer Ingelheim Investigational Site
  • 1200.131.03259 Boehringer Ingelheim Investigational Site
  • 1200.131.03256 Boehringer Ingelheim Investigational Site
  • 1200.131.03255 Boehringer Ingelheim Investigational Site
  • 1200.131.03253 Boehringer Ingelheim Investigational Site
  • 1200.131.03252 Boehringer Ingelheim Investigational Site
  • 1200.131.03254 Boehringer Ingelheim Investigational Site
  • 1200.131.03258 Boehringer Ingelheim Investigational Site
  • 1200.131.05554 Boehringer Ingelheim Investigational Site
  • 1200.131.05555 Boehringer Ingelheim Investigational Site
  • 1200.131.05557 Boehringer Ingelheim Investigational Site
  • 1200.131.05553 Boehringer Ingelheim Investigational Site
  • 1200.131.05551 Boehringer Ingelheim Investigational Site
  • 1200.131.05556 Boehringer Ingelheim Investigational Site
  • 1200.131.00152 Boehringer Ingelheim Investigational Site
  • 1200.131.00157 Boehringer Ingelheim Investigational Site
  • 1200.131.00151 Boehringer Ingelheim Investigational Site
  • 1200.131.00153 Boehringer Ingelheim Investigational Site
  • 1200.131.00154 Boehringer Ingelheim Investigational Site
  • 1200.131.00155 Boehringer Ingelheim Investigational Site
  • 1200.131.05652 Boehringer Ingelheim Investigational Site
  • 1200.131.05651 Boehringer Ingelheim Investigational Site
  • 1200.131.04254 Boehringer Ingelheim Investigational Site
  • 1200.131.04253 Boehringer Ingelheim Investigational Site
  • 1200.131.04251 Boehringer Ingelheim Investigational Site
  • 1200.131.04551 Boehringer Ingelheim Investigational Site
  • 1200.131.2052 Boehringer Ingelheim Investigational Site
  • 1200.131.35851 Boehringer Ingelheim Investigational Site
  • 1200.131.03353 Boehringer Ingelheim Investigational Site
  • 1200.131.03362 Boehringer Ingelheim Investigational Site
  • 1200.131.03359 Boehringer Ingelheim Investigational Site
  • 1200.131.03365 Boehringer Ingelheim Investigational Site
  • 1200.131.03355 Boehringer Ingelheim Investigational Site
  • 1200.131.03367 Boehringer Ingelheim Investigational Site
  • 1200.131.03370 Boehringer Ingelheim Investigational Site
  • 1200.131.03354 Boehringer Ingelheim Investigational Site
  • 1200.131.03369 Boehringer Ingelheim Investigational Site
  • 1200.131.03366 Boehringer Ingelheim Investigational Site
  • 1200.131.03356 Boehringer Ingelheim Investigational Site
  • 1200.131.03357 Boehringer Ingelheim Investigational Site
  • 1200.131.04954 Boehringer Ingelheim Investigational Site
  • 1200.131.04961 Boehringer Ingelheim Investigational Site
  • 1200.131.04953 Boehringer Ingelheim Investigational Site
  • 1200.131.04956 Boehringer Ingelheim Investigational Site
  • 1200.131.04959 Boehringer Ingelheim Investigational Site
  • 1200.131.04951 Boehringer Ingelheim Investigational Site
  • 1200.131.04957 Boehringer Ingelheim Investigational Site
  • 1200.131.04964 Boehringer Ingelheim Investigational Site
  • 1200.131.04963 Boehringer Ingelheim Investigational Site
  • 1200.131.04962 Boehringer Ingelheim Investigational Site
  • 1200.131.03054 Boehringer Ingelheim Investigational Site
  • 1200.131.03052 Boehringer Ingelheim Investigational Site
  • 1200.131.03651 Boehringer Ingelheim Investigational Site
  • 1200.131.03652 Boehringer Ingelheim Investigational Site
  • 1200.131.03656 Boehringer Ingelheim Investigational Site
  • 1200.131.03654 Boehringer Ingelheim Investigational Site
  • 1200.131.03655 Boehringer Ingelheim Investigational Site
  • 1200.131.09178 Boehringer Ingelheim Investigational Site
  • 1200.131.09165 Boehringer Ingelheim Investigational Site
  • 1200.131.09152 Boehringer Ingelheim Investigational Site
  • 1200.131.09163 Boehringer Ingelheim Investigational Site
  • 1200.131.09173 Boehringer Ingelheim Investigational Site
  • 1200.131.09179 Boehringer Ingelheim Investigational Site
  • 1200.131.09170 Boehringer Ingelheim Investigational Site
  • 1200.131.09180 Boehringer Ingelheim Investigational Site
  • 1200.131.09172 Boehringer Ingelheim Investigational Site
  • 1200.131.09176 Boehringer Ingelheim Investigational Site
  • 1200.131.09162 Boehringer Ingelheim Investigational Site
  • 1200.131.09175 Boehringer Ingelheim Investigational Site
  • 1200.131.09151 Boehringer Ingelheim Investigational Site
  • 1200.131.09164 Boehringer Ingelheim Investigational Site
  • 1200.131.09159 Boehringer Ingelheim Investigational Site
  • 1200.131.97251 Boehringer Ingelheim Investigational Site
  • 1200.131.97253 Boehringer Ingelheim Investigational Site
  • 1200.131.03957 Boehringer Ingelheim Investigational Site
  • 1200.131.03951 Boehringer Ingelheim Investigational Site
  • 1200.131.03955 Boehringer Ingelheim Investigational Site
  • 1200.131.03960 Boehringer Ingelheim Investigational Site
  • 1200.131.08156 Boehringer Ingelheim Investigational Site
  • 1200.131.08153 Boehringer Ingelheim Investigational Site
  • 1200.131.08151 Boehringer Ingelheim Investigational Site
  • 1200.131.08161 Boehringer Ingelheim Investigational Site
  • 1200.131.08157 Boehringer Ingelheim Investigational Site
  • 1200.131.08159 Boehringer Ingelheim Investigational Site
  • 1200.131.08164 Boehringer Ingelheim Investigational Site
  • 1200.131.08160 Boehringer Ingelheim Investigational Site
  • 1200.131.08155 Boehringer Ingelheim Investigational Site
  • 1200.131.08152 Boehringer Ingelheim Investigational Site
  • 1200.131.08163 Boehringer Ingelheim Investigational Site
  • 1200.131.08154 Boehringer Ingelheim Investigational Site
  • 1200.131.05252 Boehringer Ingelheim Investigational Site
  • 1200.131.03152 Boehringer Ingelheim Investigational Site
  • 1200.131.03153 Boehringer Ingelheim Investigational Site
  • 1200.131.03151 Boehringer Ingelheim Investigational Site
  • 1200.131.35155 Boehringer Ingelheim Investigational Site
  • 1200.131.35154 Boehringer Ingelheim Investigational Site
  • 1200.131.35153 Boehringer Ingelheim Investigational Site
  • 1200.131.35151 Boehringer Ingelheim Investigational Site
  • 1200.131.35152 Boehringer Ingelheim Investigational Site
  • 1200.131.00759 Boehringer Ingelheim Investigational Site
  • 1200.131.00753 Boehringer Ingelheim Investigational Site
  • 1200.131.00760 Boehringer Ingelheim Investigational Site
  • 1200.131.00761 Boehringer Ingelheim Investigational Site
  • 1200.131.00763 Boehringer Ingelheim Investigational Site
  • 1200.131.00755 Boehringer Ingelheim Investigational Site
  • 1200.131.00762 Boehringer Ingelheim Investigational Site
  • 1200.131.03451 Boehringer Ingelheim Investigational Site
  • 1200.131.03454 Boehringer Ingelheim Investigational Site
  • 1200.131.03463 Boehringer Ingelheim Investigational Site
  • 1200.131.03452 Boehringer Ingelheim Investigational Site
  • 1200.131.03459 Boehringer Ingelheim Investigational Site
  • 1200.131.03457 Boehringer Ingelheim Investigational Site
  • 1200.131.03464 Boehringer Ingelheim Investigational Site
  • 1200.131.03465 Boehringer Ingelheim Investigational Site
  • 1200.131.03456 Boehringer Ingelheim Investigational Site
  • 1200.131.03462 Boehringer Ingelheim Investigational Site
  • 1200.131.03455 Boehringer Ingelheim Investigational Site
  • 1200.131.03460 Boehringer Ingelheim Investigational Site
  • 1200.131.03466 Boehringer Ingelheim Investigational Site
  • 1200.131.03458 Boehringer Ingelheim Investigational Site
  • 1200.131.03461 Boehringer Ingelheim Investigational Site
  • 1200.131.04652 Boehringer Ingelheim Investigational Site
  • 1200.131.04651 Boehringer Ingelheim Investigational Site
  • 1200.131.04151 Boehringer Ingelheim Investigational Site
  • 1200.131.04152 Boehringer Ingelheim Investigational Site
  • 1200.131.03854 Boehringer Ingelheim Investigational Site
  • 1200.131.03851 Boehringer Ingelheim Investigational Site
  • 1200.131.04456 Boehringer Ingelheim Investigational Site
  • 1200.131.04455 Boehringer Ingelheim Investigational Site
  • 1200.131.04459 Boehringer Ingelheim Investigational Site
  • 1200.131.04460 Boehringer Ingelheim Investigational Site
  • 1200.131.04453 Boehringer Ingelheim Investigational Site
  • 1200.131.04451 Boehringer Ingelheim Investigational Site
  • 1200.131.04452 Boehringer Ingelheim Investigational Site
  • 1200.131.04454 Boehringer Ingelheim Investigational Site
  • 1200.131.04458 Boehringer Ingelheim Investigational Site
  • 1200.131.04457 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Afatinib (BIBW 2992)

Placebo

Arm Description

Once daily

Once daily

Outcomes

Primary Outcome Measures

Disease Free Survival (DFS)
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 Outcome Measures

Disease Free Survival (DFS) Rate at 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.
Percentage of Patient Deaths (Overall Survival (OS))
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.
Patients With Improved Health Related Quality of Life (HRQOL)
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.
Time to Deterioration in Health Related Quality of Life (HRQOL)
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.
Health Related Quality of Life (HRQOL) Scores Over Time
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.

Full Information

First Posted
April 28, 2011
Last Updated
November 3, 2017
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT01345669
Brief 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
Official Title
A Randomised, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Afatinib (BIBW 2992) as Adjuvant Therapy After Chemo-radiotherapy in Primary Unresected Patients With Stage III, IVa, or IVb Loco-regionally Advanced Head and Neck Squamous Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Study Start Date
October 17, 2011 (Actual)
Primary Completion Date
September 12, 2016 (Actual)
Study Completion Date
September 12, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
617 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Afatinib (BIBW 2992)
Arm Type
Experimental
Arm Description
Once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Once daily
Intervention Type
Drug
Intervention Name(s)
Afatinib
Intervention Description
Once daily
Primary Outcome Measure Information:
Title
Disease Free Survival (DFS)
Description
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.
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Disease Free Survival (DFS) Rate at 2 Years
Description
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.
Time Frame
Up to 2 years
Title
Percentage of Patient Deaths (Overall Survival (OS))
Description
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.
Time Frame
Up to 5 years
Title
Patients With Improved Health Related Quality of Life (HRQOL)
Description
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.
Time Frame
Up to 5 years
Title
Time to Deterioration in Health Related Quality of Life (HRQOL)
Description
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.
Time Frame
Up to 5 years
Title
Health Related Quality of Life (HRQOL) Scores Over Time
Description
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.
Time Frame
Baseline and 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Histologically or cytologically confirmed loco-regionally advanced head and neck squamous cell carcinoma (HNSCC), stage III to IVb Unresected tumour prior to chemo-radiotherapy (CRT) Concomitant CRT completed prior to randomisation After concomitant platinum-based CRT, no evidence of disease (NED) on clinical and radiographic examinations Eastern cooperative oncology group (ECOG) performance status 0 or 1 Exclusion criteria: Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules, EGFR-targeted antibodies, and/or any investigational agents for HNSCC Patients with smoking history of less than or equal to 10 pack years and with primary tumour site of base of tongue and/or tonsil Any other malignancy (except for simultaneous HNSCC primaries, appropriately treated superficial basal cell skin cancer and surgically cured cervical cancer in situ) unless free of disease for at least five years Known pre-existing Interstitial Lung Disease (ILD) Pregnancy or breast feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1200.131.00171 Boehringer Ingelheim Investigational Site
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
1200.131.00181 Boehringer Ingelheim Investigational Site
City
Orange
State/Province
California
Country
United States
Facility Name
1200.131.00177 Boehringer Ingelheim Investigational Site
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
1200.131.00185 Boehringer Ingelheim Investigational Site
City
New Haven
State/Province
Connecticut
Country
United States
Facility Name
1200.131.00173 Boehringer Ingelheim Investigational Site
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
1200.131.00176 Boehringer Ingelheim Investigational Site
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
1200.131.00182 Boehringer Ingelheim Investigational Site
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
1200.131.00175 Boehringer Ingelheim Investigational Site
City
Lebanon
State/Province
New Hampshire
Country
United States
Facility Name
1200.131.00179 Boehringer Ingelheim Investigational Site
City
Stony Brook
State/Province
New York
Country
United States
Facility Name
1200.131.00188 Boehringer Ingelheim Investigational Site
City
The Bronx
State/Province
New York
Country
United States
Facility Name
1200.131.10200 Boehringer Ingelheim Investigational Site
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
1200.131.00172 Boehringer Ingelheim Investigational Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
1200.131.00184 Boehringer Ingelheim Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
1200.131.00198 Boehringer Ingelheim Investigational Site
City
Spokane Valley
State/Province
Washington
Country
United States
Facility Name
1200.131.00183 Boehringer Ingelheim Investigational Site
City
Wenatchee
State/Province
Washington
Country
United States
Facility Name
1200.131.05451 Boehringer Ingelheim Investigational Site
City
Ciudad Autonoma de Bs As
Country
Argentina
Facility Name
1200.131.05457 Boehringer Ingelheim Investigational Site
City
Cordoba
Country
Argentina
Facility Name
1200.131.05458 Boehringer Ingelheim Investigational Site
City
San Miguel de Tucuman
Country
Argentina
Facility Name
1200.131.05452 Boehringer Ingelheim Investigational Site
City
Santa Fe
Country
Argentina
Facility Name
1200.131.05453 Boehringer Ingelheim Investigational Site
City
Villa Dominico
Country
Argentina
Facility Name
1200.131.06151 Boehringer Ingelheim Investigational Site
City
Wooloongabba
State/Province
Queensland
Country
Australia
Facility Name
1200.131.04353 Boehringer Ingelheim Investigational Site
City
Leoben
Country
Austria
Facility Name
1200.131.04357 Boehringer Ingelheim Investigational Site
City
Linz
Country
Austria
Facility Name
1200.131.04355 Boehringer Ingelheim Investigational Site
City
Salzburg
Country
Austria
Facility Name
1200.131.04351 Boehringer Ingelheim Investigational Site
City
Wien
Country
Austria
Facility Name
1200.131.04359 Boehringer Ingelheim Investigational Site
City
Wien
Country
Austria
Facility Name
1200.131.03259 Boehringer Ingelheim Investigational Site
City
Brussel
Country
Belgium
Facility Name
1200.131.03256 Boehringer Ingelheim Investigational Site
City
Charleroi
Country
Belgium
Facility Name
1200.131.03255 Boehringer Ingelheim Investigational Site
City
Hasselt
Country
Belgium
Facility Name
1200.131.03253 Boehringer Ingelheim Investigational Site
City
Kortrijk
Country
Belgium
Facility Name
1200.131.03252 Boehringer Ingelheim Investigational Site
City
Liège
Country
Belgium
Facility Name
1200.131.03254 Boehringer Ingelheim Investigational Site
City
Liège
Country
Belgium
Facility Name
1200.131.03258 Boehringer Ingelheim Investigational Site
City
Namur
Country
Belgium
Facility Name
1200.131.05554 Boehringer Ingelheim Investigational Site
City
Barretos
Country
Brazil
Facility Name
1200.131.05555 Boehringer Ingelheim Investigational Site
City
Jau
Country
Brazil
Facility Name
1200.131.05557 Boehringer Ingelheim Investigational Site
City
Passo Fundo
Country
Brazil
Facility Name
1200.131.05553 Boehringer Ingelheim Investigational Site
City
Porto Alegre
Country
Brazil
Facility Name
1200.131.05551 Boehringer Ingelheim Investigational Site
City
Sao Paulo
Country
Brazil
Facility Name
1200.131.05556 Boehringer Ingelheim Investigational Site
City
Sao Paulo
Country
Brazil
Facility Name
1200.131.00152 Boehringer Ingelheim Investigational Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
1200.131.00157 Boehringer Ingelheim Investigational Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
1200.131.00151 Boehringer Ingelheim Investigational Site
City
Windsor
State/Province
Ontario
Country
Canada
Facility Name
1200.131.00153 Boehringer Ingelheim Investigational Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
1200.131.00154 Boehringer Ingelheim Investigational Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
1200.131.00155 Boehringer Ingelheim Investigational Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
1200.131.05652 Boehringer Ingelheim Investigational Site
City
Vina De Mar
Country
Chile
Facility Name
1200.131.05651 Boehringer Ingelheim Investigational Site
City
Vina del Mar
Country
Chile
Facility Name
1200.131.04254 Boehringer Ingelheim Investigational Site
City
Brno
Country
Czechia
Facility Name
1200.131.04253 Boehringer Ingelheim Investigational Site
City
Praha 5
Country
Czechia
Facility Name
1200.131.04251 Boehringer Ingelheim Investigational Site
City
Praha 8
Country
Czechia
Facility Name
1200.131.04551 Boehringer Ingelheim Investigational Site
City
København Ø
Country
Denmark
Facility Name
1200.131.2052 Boehringer Ingelheim Investigational Site
City
Alexandria
Country
Egypt
Facility Name
1200.131.35851 Boehringer Ingelheim Investigational Site
City
Turku
Country
Finland
Facility Name
1200.131.03353 Boehringer Ingelheim Investigational Site
City
Le Havre
Country
France
Facility Name
1200.131.03362 Boehringer Ingelheim Investigational Site
City
Marseille Cedex 5
Country
France
Facility Name
1200.131.03359 Boehringer Ingelheim Investigational Site
City
Nice cedex 2
Country
France
Facility Name
1200.131.03365 Boehringer Ingelheim Investigational Site
City
Orléans Cedex 2
Country
France
Facility Name
1200.131.03355 Boehringer Ingelheim Investigational Site
City
Pierre-Bénite
Country
France
Facility Name
1200.131.03367 Boehringer Ingelheim Investigational Site
City
Rouen
Country
France
Facility Name
1200.131.03370 Boehringer Ingelheim Investigational Site
City
Saint Cloud
Country
France
Facility Name
1200.131.03354 Boehringer Ingelheim Investigational Site
City
Saint Herblain Cedex
Country
France
Facility Name
1200.131.03369 Boehringer Ingelheim Investigational Site
City
Saint Priest en Jarez
Country
France
Facility Name
1200.131.03366 Boehringer Ingelheim Investigational Site
City
Salouel
Country
France
Facility Name
1200.131.03356 Boehringer Ingelheim Investigational Site
City
Tours
Country
France
Facility Name
1200.131.03357 Boehringer Ingelheim Investigational Site
City
Villejuif Cedex
Country
France
Facility Name
1200.131.04954 Boehringer Ingelheim Investigational Site
City
Essen
Country
Germany
Facility Name
1200.131.04961 Boehringer Ingelheim Investigational Site
City
Freiburg
Country
Germany
Facility Name
1200.131.04953 Boehringer Ingelheim Investigational Site
City
Hannover
Country
Germany
Facility Name
1200.131.04956 Boehringer Ingelheim Investigational Site
City
Jena
Country
Germany
Facility Name
1200.131.04959 Boehringer Ingelheim Investigational Site
City
Kaiserslautern
Country
Germany
Facility Name
1200.131.04951 Boehringer Ingelheim Investigational Site
City
Leipzig
Country
Germany
Facility Name
1200.131.04957 Boehringer Ingelheim Investigational Site
City
Rostock
Country
Germany
Facility Name
1200.131.04964 Boehringer Ingelheim Investigational Site
City
Trier
Country
Germany
Facility Name
1200.131.04963 Boehringer Ingelheim Investigational Site
City
Ulm
Country
Germany
Facility Name
1200.131.04962 Boehringer Ingelheim Investigational Site
City
Villingen-Schwenningen
Country
Germany
Facility Name
1200.131.03054 Boehringer Ingelheim Investigational Site
City
Chaidari
Country
Greece
Facility Name
1200.131.03052 Boehringer Ingelheim Investigational Site
City
Thessaloniki
Country
Greece
Facility Name
1200.131.03651 Boehringer Ingelheim Investigational Site
City
Budapest
Country
Hungary
Facility Name
1200.131.03652 Boehringer Ingelheim Investigational Site
City
Budapest
Country
Hungary
Facility Name
1200.131.03656 Boehringer Ingelheim Investigational Site
City
Budpest
Country
Hungary
Facility Name
1200.131.03654 Boehringer Ingelheim Investigational Site
City
Debrecen
Country
Hungary
Facility Name
1200.131.03655 Boehringer Ingelheim Investigational Site
City
Kecskemet
Country
Hungary
Facility Name
1200.131.09178 Boehringer Ingelheim Investigational Site
City
Ahmadabad
Country
India
Facility Name
1200.131.09165 Boehringer Ingelheim Investigational Site
City
Bangalore
Country
India
Facility Name
1200.131.09152 Boehringer Ingelheim Investigational Site
City
Bikaner
Country
India
Facility Name
1200.131.09163 Boehringer Ingelheim Investigational Site
City
Chennai
Country
India
Facility Name
1200.131.09173 Boehringer Ingelheim Investigational Site
City
Chennai
Country
India
Facility Name
1200.131.09179 Boehringer Ingelheim Investigational Site
City
Delhi
Country
India
Facility Name
1200.131.09170 Boehringer Ingelheim Investigational Site
City
Gurgaon
Country
India
Facility Name
1200.131.09180 Boehringer Ingelheim Investigational Site
City
Hyderabad
Country
India
Facility Name
1200.131.09172 Boehringer Ingelheim Investigational Site
City
Jaipur
Country
India
Facility Name
1200.131.09176 Boehringer Ingelheim Investigational Site
City
Karamsad,Anand, Gujarat
Country
India
Facility Name
1200.131.09162 Boehringer Ingelheim Investigational Site
City
Madurai, Tamil Nadu
Country
India
Facility Name
1200.131.09175 Boehringer Ingelheim Investigational Site
City
Mazagaon, Mumbai
Country
India
Facility Name
1200.131.09151 Boehringer Ingelheim Investigational Site
City
New Delhi
Country
India
Facility Name
1200.131.09164 Boehringer Ingelheim Investigational Site
City
Pune
Country
India
Facility Name
1200.131.09159 Boehringer Ingelheim Investigational Site
City
Vishakapatnam
Country
India
Facility Name
1200.131.97251 Boehringer Ingelheim Investigational Site
City
Haifa
Country
Israel
Facility Name
1200.131.97253 Boehringer Ingelheim Investigational Site
City
Petach Tikva
Country
Israel
Facility Name
1200.131.03957 Boehringer Ingelheim Investigational Site
City
Confreria (CN)
Country
Italy
Facility Name
1200.131.03951 Boehringer Ingelheim Investigational Site
City
Milano
Country
Italy
Facility Name
1200.131.03955 Boehringer Ingelheim Investigational Site
City
Milano
Country
Italy
Facility Name
1200.131.03960 Boehringer Ingelheim Investigational Site
City
Milano
Country
Italy
Facility Name
1200.131.08156 Boehringer Ingelheim Investigational Site
City
Aichi, Nagoya
Country
Japan
Facility Name
1200.131.08153 Boehringer Ingelheim Investigational Site
City
Chiba, Kashiwa
Country
Japan
Facility Name
1200.131.08151 Boehringer Ingelheim Investigational Site
City
Hokkaido, Sapporo
Country
Japan
Facility Name
1200.131.08161 Boehringer Ingelheim Investigational Site
City
Hyogo, Akashi
Country
Japan
Facility Name
1200.131.08157 Boehringer Ingelheim Investigational Site
City
Hyogo, Kobe
Country
Japan
Facility Name
1200.131.08159 Boehringer Ingelheim Investigational Site
City
Kanagawa, Isehara
Country
Japan
Facility Name
1200.131.08164 Boehringer Ingelheim Investigational Site
City
Miyagi, Natori
Country
Japan
Facility Name
1200.131.08160 Boehringer Ingelheim Investigational Site
City
Osaka, Osaka
Country
Japan
Facility Name
1200.131.08155 Boehringer Ingelheim Investigational Site
City
Shizuoka, Sunto-gun
Country
Japan
Facility Name
1200.131.08152 Boehringer Ingelheim Investigational Site
City
Tochigi, Shimotsuke
Country
Japan
Facility Name
1200.131.08163 Boehringer Ingelheim Investigational Site
City
Tokyo, Koto-ku
Country
Japan
Facility Name
1200.131.08154 Boehringer Ingelheim Investigational Site
City
Tokyo, Meguro-ku
Country
Japan
Facility Name
1200.131.05252 Boehringer Ingelheim Investigational Site
City
Mexico
Country
Mexico
Facility Name
1200.131.03152 Boehringer Ingelheim Investigational Site
City
Amsterdam
Country
Netherlands
Facility Name
1200.131.03153 Boehringer Ingelheim Investigational Site
City
Leiden
Country
Netherlands
Facility Name
1200.131.03151 Boehringer Ingelheim Investigational Site
City
Rotterdam
Country
Netherlands
Facility Name
1200.131.35155 Boehringer Ingelheim Investigational Site
City
Almada
Country
Portugal
Facility Name
1200.131.35154 Boehringer Ingelheim Investigational Site
City
Coimbra
Country
Portugal
Facility Name
1200.131.35153 Boehringer Ingelheim Investigational Site
City
Lisboa
Country
Portugal
Facility Name
1200.131.35151 Boehringer Ingelheim Investigational Site
City
Porto
Country
Portugal
Facility Name
1200.131.35152 Boehringer Ingelheim Investigational Site
City
Évora
Country
Portugal
Facility Name
1200.131.00759 Boehringer Ingelheim Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
1200.131.00753 Boehringer Ingelheim Investigational Site
City
Omsk
Country
Russian Federation
Facility Name
1200.131.00760 Boehringer Ingelheim Investigational Site
City
Pyatigorsk
Country
Russian Federation
Facility Name
1200.131.00761 Boehringer Ingelheim Investigational Site
City
Pyatigorsk
Country
Russian Federation
Facility Name
1200.131.00763 Boehringer Ingelheim Investigational Site
City
St. Petersburg
Country
Russian Federation
Facility Name
1200.131.00755 Boehringer Ingelheim Investigational Site
City
Ufa
Country
Russian Federation
Facility Name
1200.131.00762 Boehringer Ingelheim Investigational Site
City
Ufa
Country
Russian Federation
Facility Name
1200.131.03451 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
1200.131.03454 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
1200.131.03463 Boehringer Ingelheim Investigational Site
City
Girona
Country
Spain
Facility Name
1200.131.03452 Boehringer Ingelheim Investigational Site
City
Hospitalet de Llobregat
Country
Spain
Facility Name
1200.131.03459 Boehringer Ingelheim Investigational Site
City
Lugo
Country
Spain
Facility Name
1200.131.03457 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
1200.131.03464 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
1200.131.03465 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
1200.131.03456 Boehringer Ingelheim Investigational Site
City
Málaga
Country
Spain
Facility Name
1200.131.03462 Boehringer Ingelheim Investigational Site
City
Málaga
Country
Spain
Facility Name
1200.131.03455 Boehringer Ingelheim Investigational Site
City
Pamplona
Country
Spain
Facility Name
1200.131.03460 Boehringer Ingelheim Investigational Site
City
Pozuelo De Alarcón, Madrid
Country
Spain
Facility Name
1200.131.03466 Boehringer Ingelheim Investigational Site
City
Sevilla
Country
Spain
Facility Name
1200.131.03458 Boehringer Ingelheim Investigational Site
City
Zaragoza
Country
Spain
Facility Name
1200.131.03461 Boehringer Ingelheim Investigational Site
City
Ávila
Country
Spain
Facility Name
1200.131.04652 Boehringer Ingelheim Investigational Site
City
Göteborg
Country
Sweden
Facility Name
1200.131.04651 Boehringer Ingelheim Investigational Site
City
Stockholm
Country
Sweden
Facility Name
1200.131.04151 Boehringer Ingelheim Investigational Site
City
Basel
Country
Switzerland
Facility Name
1200.131.04152 Boehringer Ingelheim Investigational Site
City
Bern
Country
Switzerland
Facility Name
1200.131.03854 Boehringer Ingelheim Investigational Site
City
Kharkiv
Country
Ukraine
Facility Name
1200.131.03851 Boehringer Ingelheim Investigational Site
City
Kiev
Country
Ukraine
Facility Name
1200.131.04456 Boehringer Ingelheim Investigational Site
City
Denbighshire
Country
United Kingdom
Facility Name
1200.131.04455 Boehringer Ingelheim Investigational Site
City
Edinburgh
Country
United Kingdom
Facility Name
1200.131.04459 Boehringer Ingelheim Investigational Site
City
Exeter
Country
United Kingdom
Facility Name
1200.131.04460 Boehringer Ingelheim Investigational Site
City
Glasgow
Country
United Kingdom
Facility Name
1200.131.04453 Boehringer Ingelheim Investigational Site
City
Leicester
Country
United Kingdom
Facility Name
1200.131.04451 Boehringer Ingelheim Investigational Site
City
London
Country
United Kingdom
Facility Name
1200.131.04452 Boehringer Ingelheim Investigational Site
City
Manchester
Country
United Kingdom
Facility Name
1200.131.04454 Boehringer Ingelheim Investigational Site
City
Sheffield
Country
United Kingdom
Facility Name
1200.131.04458 Boehringer Ingelheim Investigational Site
City
Sutton
Country
United Kingdom
Facility Name
1200.131.04457 Boehringer Ingelheim Investigational Site
City
Whitchurch, Cardiff
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
31194247
Citation
Burtness B, Haddad R, Dinis J, Trigo J, Yokota T, de Souza Viana L, Romanov I, Vermorken J, Bourhis J, Tahara M, Martins Segalla JG, Psyrri A, Vasilevskaya I, Nangia CS, Chaves-Conde M, Kiyota N, Homma A, Holeckova P, Del Campo JM, Asarawala N, Nicolau UR, Rauch D, Even C, Wang B, Gibson N, Ehrnrooth E, Harrington K, Cohen EEW; LUX-Head & Neck 2 investigators. Afatinib vs Placebo as Adjuvant Therapy After Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck: A Randomized Clinical Trial. JAMA Oncol. 2019 Aug 1;5(8):1170-1180. doi: 10.1001/jamaoncol.2019.1146.
Results Reference
derived
PubMed Identifier
25432788
Citation
Burtness B, Bourhis JP, Vermorken JB, Harrington KJ, Cohen EE. Afatinib versus placebo as adjuvant therapy after chemoradiation in a double-blind, phase III study (LUX-Head & Neck 2) in patients with primary unresected, clinically intermediate-to-high-risk head and neck cancer: study protocol for a randomized controlled trial. Trials. 2014 Nov 29;15:469. doi: 10.1186/1745-6215-15-469.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com
Description
Related Info

Learn more about this trial

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

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