Head and Neck NeoplasmsPhase 3NCT02131155
LUX-Head & Neck 4: Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy
A Phase 3 study testing Afatinib in people with Head and Neck Neoplasms, run by Boehringer Ingelheim at 17 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- Afatinib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 17 sitesin 4 countries
- Study dates
- 17 Jul 2014to 22 Aug 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- Cancer of nasopharynx, sinuses, and/or salivary glands
- Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules, EGFR-targeted antibodies, and/or any investigational agents for HNSCC
- Known pre-existing Interstitial Lung Disease (ILD)
- Any past or present history of areca/betel-nut chewing or its derivatives for a cumulative duration of more than 3 months
Trial locations and contacts
17 sites in 4 countries.
17 sites in 4 countries
China13 sites
1200.162.86010 Boehringer Ingelheim Investigational Site
Beijing
1200.162.86012 Boehringer Ingelheim Investigational Site
Beijing
1200.162.86019 Boehringer Ingelheim Investigational Site
Changchun
1200.162.86007 Boehringer Ingelheim Investigational Site
Chengdu
1200.162.86017 Boehringer Ingelheim Investigational Site
Fuzhou
1200.162.86005 Boehringer Ingelheim Investigational Site
Guangzhou
1200.162.86003 Boehringer Ingelheim Investigational Site
Hangzhou
1200.162.86013 Boehringer Ingelheim Investigational Site
Jinan
1200.162.86014 Boehringer Ingelheim Investigational Site
Nanning
1200.162.86001 Boehringer Ingelheim Investigational Site
Shanghai
1200.162.86020 Boehringer Ingelheim Investigational Site
Tianjin
1200.162.86004 Boehringer Ingelheim Investigational Site
Wuhan
1200.162.86018 Boehringer Ingelheim Investigational Site
Wuhan
South Korea2 sites
1200.162.82001 Boehringer Ingelheim Investigational Site
Seoul
1200.162.82002 Boehringer Ingelheim Investigational Site
Seoul
About this study
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
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.
- Conditions
- Head and Neck Neoplasms
- Being tested
- Placebo, Afatinib
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Once daily
AfatinibDrug
Once daily
| Study group | Role | What they receive |
|---|---|---|
| Afatinib (BIBW2992) | Experimental | Once daily Receives: Drug: Afatinib |
| Placebo | Placebo comparator | Once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival (DFS)
DFS, defined as the number of days from the date of randomisation to the date of tumour recurrence/ Second Primary Tumours (SPT) or death from any cause, whichever occurred first.
For patients with known date of tumour recurrence/SPT (or death), the event date was the date of tumour recurrence/SPT or the date of death, whichever came first, i.e.
DFS [day] = minimum (date of tumour recurrence/SPT, date of death) - date of randomisation +1.
For patients known to be alive and without tumour recurrence/SPT by the end of trial or follow-up visit, they were censored at the date of last imaging when the patient was known to be disease-free and alive:
DFS (censored) [days] = date of last imaging when the patient was known to be diseasefree and alive - date of randomisation + 1. The Kaplan-Meier (KM) method was to be used to estimate the median DFS for each treatment group. 95% confidence interval (CI) was to be constructed using the Greenwood variance estimate.
Measured: up to 4 years
Secondary outcomes (3)
Disease Free Survival (DFS) Rate at 2 Years
Disease Free Survival (DFS) rate at 2 years is presented
Measured: up to 2 years
Overall Survival (OS)
OS was defined as time from the date of randomisation until death.
For patients with known date of death (regardless of the cause of death):
OS [days] = date of death - date of randomisation +1
For patients known to be alive by the end of trial:
OS (censored) [days] = the last date when the patient was known to be alive - date of randomisation +1 OS was to be analysed similarly to DFS.
Measured: up to 4 years
Health Related Quality of Life (HRQOL)
The main analysis of HRQOL questionnaires was to focus on the change in score from baseline in the following scales measured on the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and EORTC QLQ-H\&N35:
- Global Health Status/ Quality of Life (QOL) Scale
- Pain Scale
- Swallowing Scale
Measured: up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study start17 Jul 2014
- Primary completion22 Aug 2016
- Study completion22 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131155
- Sponsor's protocol ID
- 1200.162
- Status last verified
- Oct 2018
- First submitted
- 5 May 2014
- Last updated
- 1 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02131155
- Acronym / sponsor ID
- 1200.162
- Conditions
- Head and Neck Neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2014 (actual)
- Primary completion
- 22 Aug 2016 (actual)
- Study completion
- 22 Aug 2016 (actual)
- First posted
- 6 May 2014 (estimated)
- Results
- Posted 1 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Afatinib (BIBW2992) | Experimental | Drug: AfatinibOnce daily |
| Placebo | Placebo comparator | Drug: PlaceboOnce daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
- Cancer of nasopharynx, sinuses, and/or salivary glands
- Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules, EGFR-targeted antibodies, and/or any investigational agents for HNSCC
- Known pre-existing Interstitial Lung Disease (ILD)
- Any past or present history of areca/betel-nut chewing or its derivatives for a cumulative duration of more than 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboOnce daily | Drug | Placebo |
| AfatinibOnce daily | Drug | Afatinib (BIBW2992) |
Primary outcome
Disease Free Survival (DFS)
Time frame: up to 4 years
DFS, defined as the number of days from the date of randomisation to the date of tumour recurrence/ Second Primary Tumours (SPT) or death from any cause, whichever occurred first. For patients with known date of tumour recurrence/SPT (or death), the event date was the date of tumour recurrence/SPT or the date of death, whichever came first, i.e. DFS [day] = minimum (date of tumour recurrence/SPT, date of death) - date of randomisation +1. For patients known to be alive and without tumour recurrence/SPT by the end of trial or follow-up visit, they were censored at the date of last imaging when the patient was known to be disease-free and alive: DFS (censored) [days] = date of last imaging when the patient was known to be diseasefree and alive - date of randomisation + 1. The Kaplan-Meier (KM) method was to be used to estimate the median DFS for each treatment group. 95% confidence interval (CI) was to be constructed using the Greenwood variance estimate.
3 secondary outcomes
Disease Free Survival (DFS) Rate at 2 Years
Time frame: up to 2 years
Overall Survival (OS)
Time frame: up to 4 years
Health Related Quality of Life (HRQOL)
Time frame: up to 4 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
17 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Afatinib in people with Head and Neck Neoplasms, run by Boehringer Ingelheim at 17 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in China, South Korea, Singapore, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Free Survival (DFS) (time frame: up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2019.