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LUX-Head & Neck 4: Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy

NCT ID: NCT02131155

Last Updated: 2019-03-01

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-17

Study Completion Date

2016-08-22

Brief Summary

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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.

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LUX-Head&Neck 1: A Phase III Trial of Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic (R/M) Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy

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Detailed Description

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Conditions

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Head and Neck Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Afatinib (BIBW2992)

Once daily

Group Type EXPERIMENTAL

Afatinib

Intervention Type DRUG

Once daily

Placebo

Once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Once daily

Interventions

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Placebo

Once daily

Intervention Type DRUG

Afatinib

Once daily

Intervention Type DRUG

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1200.162.86010 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1200.162.86012 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1200.162.86019 Boehringer Ingelheim Investigational Site

Changchun, , China

Site Status

1200.162.86007 Boehringer Ingelheim Investigational Site

Chengdu, , China

Site Status

1200.162.86017 Boehringer Ingelheim Investigational Site

Fuzhou, , China

Site Status

1200.162.86005 Boehringer Ingelheim Investigational Site

Guangzhou, , China

Site Status

1200.162.86003 Boehringer Ingelheim Investigational Site

Hangzhou, , China

Site Status

1200.162.86013 Boehringer Ingelheim Investigational Site

Jinan, , China

Site Status

1200.162.86014 Boehringer Ingelheim Investigational Site

Nanning, , China

Site Status

1200.162.86001 Boehringer Ingelheim Investigational Site

Shanghai, , China

Site Status

1200.162.86020 Boehringer Ingelheim Investigational Site

Tianjin, , China

Site Status

1200.162.86004 Boehringer Ingelheim Investigational Site

Wuhan, , China

Site Status

1200.162.86018 Boehringer Ingelheim Investigational Site

Wuhan, , China

Site Status

Singapore, , Singapore

Site Status

1200.162.82001 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1200.162.82002 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1200.162.88603 Boehringer Ingelheim Investigational Site

Keelung, , Taiwan

Site Status

Countries

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China Singapore South Korea Taiwan

Other Identifiers

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1200.162

Identifier Type: -

Identifier Source: org_study_id

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