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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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01345669
First Posted: May 2, 2011
Last Update Posted: October 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
Results First Submitted: August 17, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition: Head and Neck Neoplasms
Interventions: Drug: Placebo
Drug: Afatinib

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This was a randomised, placebo-controlled, double-blind, parallel arms, multinational phase III trial in which patients were randomised 2:1 to Afatinib or Placebo.

Reporting Groups
  Description
Afatinib (BIBW 2992) Patient received Afatinib film-coated tablets with starting dose 40 mg (milligram)/day and escalation to 50 mg/day and/or reduction to 40, 30 or 20 mg/day according to absence or presence of drug-related adverse events (AEs), orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.
Placebo Patient received placebo matching Afatinib film-coated tablets with matching Afatinib dosage regimen, orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.

Participant Flow:   Overall Study
    Afatinib (BIBW 2992)   Placebo
STARTED   411   206 
COMPLETED   124   87 
NOT COMPLETED   287   119 
Primary tumour recurrence                53                32 
Second primary tumour                4                3 
Adverse Event                63                9 
Protocol Violation                3                1 
Lost to Follow-up                1                1 
Withdrawal by Subject                52                13 
Other Reasons                111                60 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomised Set (RS): Included all patients who were randomised, regardless of taking investigational treatment (as randomised)

Reporting Groups
  Description
Afatinib (BIBW 2992) Patient received Afatinib film-coated tablets with starting dose 40 mg (milligram)/day and escalation to 50 mg/day and/or reduction to 40, 30 or 20 mg/day according to absence or presence of drug-related adverse events (AEs), orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.
Placebo Patient received placebo matching Afatinib film-coated tablets with matching Afatinib dosage regimen, orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal.
Total Total of all reporting groups

Baseline Measures
   Afatinib (BIBW 2992)   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 411   206   617 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.3  (8.23)   57.3  (8.64)   58.0  (8.38) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      61  14.8%      28  13.6%      89  14.4% 
Male      350  85.2%      178  86.4%      528  85.6% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Disease Free Survival (DFS)   [ Time Frame: Up to 5 years ]

2.  Secondary:   Disease Free Survival (DFS) Rate at 2 Years   [ Time Frame: Up to 2 years ]

3.  Secondary:   Percentage of Patient Deaths (Overall Survival (OS))   [ Time Frame: Up to 5 years ]

4.  Secondary:   Patients With Improved Health Related Quality of Life (HRQOL)   [ Time Frame: Up to 5 years ]

5.  Secondary:   Time to Deterioration in Health Related Quality of Life (HRQOL)   [ Time Frame: Up to 5 years ]

6.  Secondary:   Health Related Quality of Life (HRQOL) Scores Over Time   [ Time Frame: Baseline and 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The trial was stopped prematurely due to futility.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim, Call Center
Organization: Boehringer Ingelheim
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01345669     History of Changes
Other Study ID Numbers: 1200.131
2011-000392-14 ( EudraCT Number: EudraCT )
First Submitted: April 28, 2011
First Posted: May 2, 2011
Results First Submitted: August 17, 2017
Results First Posted: October 23, 2017
Last Update Posted: October 23, 2017