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

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Primary Purpose

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Placebo

Afatinib

About this trial

This is an interventional treatment trial for Head and Neck Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Afatinib (BIBW2992)

Placebo

Arm Description

Once daily

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Disease Free Survival (DFS) Rate at 2 Years

Disease Free Survival (DFS) rate at 2 years is presented

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.

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

Full Information

NCT ID

NCT02131155

First Posted

May 5, 2014

Last Updated

October 29, 2018

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT02131155

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Terminated

Study Start Date

July 17, 2014 (Actual)

Primary Completion Date

August 22, 2016 (Actual)

Study Completion Date

August 22, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Afatinib (BIBW2992)

Arm Type

Experimental

Arm Description

Once daily

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Once daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Once daily

Intervention Type

Drug

Intervention Name(s)

Afatinib

Intervention Description

Once daily

Primary Outcome Measure Information:

Title

Disease Free Survival (DFS)

Description

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.

Time Frame

up to 4 years

Secondary Outcome Measure Information:

Title

Disease Free Survival (DFS) Rate at 2 Years

Description

Disease Free Survival (DFS) rate at 2 years is presented

Time Frame

up to 2 years

Title

Overall Survival (OS)

Description

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.

Time Frame

up to 4 years

Title

Health Related Quality of Life (HRQOL)

Description

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

Time Frame

up to 4 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boehringer Ingelheim

Organizational Affiliation

Boehringer Ingelheim

Official's Role

Study Chair

Facility Information:

Facility Name

1200.162.86010 Boehringer Ingelheim Investigational Site

City

Beijing

Country

China

Facility Name

1200.162.86012 Boehringer Ingelheim Investigational Site

City

Beijing

Country

China

Facility Name

1200.162.86019 Boehringer Ingelheim Investigational Site

City

Changchun

Country

China

Facility Name

1200.162.86007 Boehringer Ingelheim Investigational Site

City

Chengdu

Country

China

Facility Name

1200.162.86017 Boehringer Ingelheim Investigational Site

City

Fuzhou

Country

China

Facility Name

1200.162.86005 Boehringer Ingelheim Investigational Site

City

Guangzhou

Country

China

Facility Name

1200.162.86003 Boehringer Ingelheim Investigational Site

City

Hangzhou

Country

China

Facility Name

1200.162.86013 Boehringer Ingelheim Investigational Site

City

Jinan

Country

China

Facility Name

1200.162.86014 Boehringer Ingelheim Investigational Site

City

Nanning

Country

China

Facility Name

1200.162.86001 Boehringer Ingelheim Investigational Site

City

Shanghai

Country

China

Facility Name

1200.162.86020 Boehringer Ingelheim Investigational Site

City

Tianjin

Country

China

Facility Name

1200.162.86004 Boehringer Ingelheim Investigational Site

City

Wuhan

Country

China

Facility Name

1200.162.86018 Boehringer Ingelheim Investigational Site

City

Wuhan

Country

China

Facility Name

1200.162.82001 Boehringer Ingelheim Investigational Site

City

Seoul

Country

Korea, Republic of

Facility Name

1200.162.82002 Boehringer Ingelheim Investigational Site

City

Seoul

Country

Korea, Republic of

City

Singapore

Country

Singapore

Facility Name

1200.162.88603 Boehringer Ingelheim Investigational Site

City

Keelung City

Country

Taiwan

12. IPD Sharing Statement

Links:

URL

http://trials.boehringer-ingelheim.com/

Description

Related Info

Head and Neck Neoplasms

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial