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

NCT02131155 | Terminated Phase 3 Results

• 1 other identifier: 1200.162
• Study Type: interventional
• Target: 36
• Locations: 4 countries
• Sites: 17

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.

Conditions

Head and Neck Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 4 years

Secondary Outcomes (3)

• Disease Free Survival (DFS) Rate at 2 Years

  up to 2 years

• Overall Survival (OS)

  up to 4 years

• Health Related Quality of Life (HRQOL)

  up to 4 years

Study Arms (2)

Afatinib (BIBW2992)

EXPERIMENTAL

Once daily

Drug: Afatinib

Placebo

PLACEBO COMPARATOR

Once daily

Drug: Placebo

Interventions

Placebo DRUG

Once daily

Placebo

Afatinib DRUG

Once daily

Afatinib (BIBW2992)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (17)

1200.162.86010 Boehringer Ingelheim Investigational Site

Beijing, China

Location

1200.162.86012 Boehringer Ingelheim Investigational Site

Beijing, China

Location

1200.162.86019 Boehringer Ingelheim Investigational Site

Changchun, China

Location

1200.162.86007 Boehringer Ingelheim Investigational Site

Chengdu, China

Location

1200.162.86017 Boehringer Ingelheim Investigational Site

Fuzhou, China

Location

1200.162.86005 Boehringer Ingelheim Investigational Site

Guangzhou, China

Location

1200.162.86003 Boehringer Ingelheim Investigational Site

Hangzhou, China

Location

1200.162.86013 Boehringer Ingelheim Investigational Site

Jinan, China

Location

1200.162.86014 Boehringer Ingelheim Investigational Site

Nanning, China

Location

1200.162.86001 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

1200.162.86020 Boehringer Ingelheim Investigational Site

Tianjin, China

Location

1200.162.86004 Boehringer Ingelheim Investigational Site

Wuhan, China

Location

1200.162.86018 Boehringer Ingelheim Investigational Site

Wuhan, China

Location

Unknown Facility

Singapore, Singapore

Location

1200.162.82001 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1200.162.82002 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1200.162.88603 Boehringer Ingelheim Investigational Site

Keelung, Taiwan

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Afatinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

The study was early terminated by the sponsor along with the global companion trial 1200.131 (NCT01345669), following the recommendation from the external Data Monitoring Committee (DMC) due to futility of 1200.131, but not due to safety concern.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2014
• First Posted: May 6, 2014
• Study Start: July 17, 2014
• Primary Completion: August 22, 2016
• Study Completion: August 22, 2016
• Last Updated: March 1, 2019
• Results First Posted: March 1, 2019

Record last verified: 2018-10

Locations

TW (1); KR (2); CN (13); SG (1)