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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| ClinicalTrials.gov Identifier: NCT01345669 |
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Recruitment Status :
Terminated
First Posted : May 2, 2011
Results First Posted : October 23, 2017
Last Update Posted : December 7, 2017
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Sponsor:
Boehringer Ingelheim
Information provided by (Responsible Party):
Boehringer Ingelheim
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| 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 |
| Enrollment | 617 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details | 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. |
| Arm/Group Title | Afatinib (BIBW 2992) | Placebo |
|---|---|---|
 Arm/Group Description |
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. | 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. |
| Period Title: Overall Study | ||
| Started | 411 | 206 |
| Completed | 124 | 87 |
| Not Completed | 287 | 119 |
| Reason Not Completed | ||
| 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
| Arm/Group Title | Afatinib (BIBW 2992) | Placebo | Total | |
|---|---|---|---|---|
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Arm/Group Description |
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. | 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 of all reporting groups | |
| Overall Number of Baseline Participants | 411 | 206 | 617 | |
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Baseline Analysis Population Description |
Randomised Set (RS): Included all patients who were randomised, regardless of taking investigational treatment (as randomised)
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 411 participants | 206 participants | 617 participants | |
| 58.3 (8.23) | 57.3 (8.64) | 58.0 (8.38) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 411 participants | 206 participants | 617 participants | |
| Female |
61 14.8%
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28 13.6%
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89 14.4%
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| Male |
350 85.2%
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178 86.4%
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528 85.6%
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Outcome Measures
Adverse Events
Limitations and Caveats
The trial was stopped prematurely due to futility.
More Information
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.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Results Point of Contact
| Name/Title: | Boehringer Ingelheim, Call Center |
| Organization: | Boehringer Ingelheim |
| Phone: | 1-800-243-0127 |
| EMail: | 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 |
| 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: | December 7, 2017 |