A randomised, open-label, phase III study to check the efficacy and safety of oral afatinib versus intravenous methotrexate in patients with recurrent and/or metastatic head and neck squamous cell carcinoma (Cancer) who have progressed after platinum-based therapy like cisplatin or carboplatin.

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/08/004896
• Date of registration: 20-08-2014
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim India Pvt Ltd
• Public title: A randomised, open-label, phase III study to check the efficacy and safety of oral afatinib versus intravenous methotrexate in patients with recurrent and/or metastatic head and neck squamous cell carcinoma (Cancer) who have progressed after platinum-based therapy like cisplatin or carboplatin.
• Scientific title: A randomised, open-label, phase III study to evaluate the efficacy and safety of oral afatinib (BIBW 2992) versus intravenous methotrexate in patients with recurrent and/or metastatic head and neck squamous cell carcinoma who have progressed after platinum-based therapy - LUX-Head & Neck 3
• Date of first enrolment: 25-09-2014
• Target sample size: 300
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=8666
• Study type: Interventional
• Study design: Randomized, Parallel Group, Active Controlled Trial; Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Centralized Blinding and masking:Open Label
• Phase: Phase 3

Countries of recruitment

China, Egypt, Hong Kong, India, Philippines, Republic of Korea, Taiwan

Contacts

• Name: Dr Partha Gokhale
• Affiliation: Boehringer Ingelheim India Pvt Ltd

• Name: Mr Sachin S Sadekar
• Affiliation: Boehringer Ingelheim India Pvt Ltd

Key inclusion & exclusion criteria

Inclusion criteria: Histologically or cytologically confirmed squamour cell carcinoma of the roal cavity, oropharynx, hypopharynx or larynx, which has recurred/metastasised and is not amenable for salvage surgery or radiotherapy

Documented porgressive deisase based on investigator assessment according to RECIST, following receipt of cisplatin and or carboplatin based regimen administered for recurrent and or metastatic disease independent of whether patient progressed during or after platinumbased therapy.

Measurable disease according to RECIST 1.1

ECOG performance status 1 or 1 at visit 2.
Exclusion criteria: • Progressive disease within three months of completion of curatively intended

treatment for locoregionally advanced HNSCC or for metastatic HNSCC.

• Primary tumour site nasopharynx (of any histology), sinuses, and/or salivary

glands

• Any other than one previous platinum-based systemic regimen given for recurrent

and/or metastatic disease. Re-challenge with the first line regimen after a

temporary break is considered a second line regimen only in case of progression

within the break.

• Prior treatment with EGFR-targeted small molecules.

• Unresolved chronic toxicity, other than hearing loss, tinnitus or dry mouth,

CTCAE grade 2 from previous anti-cancer therapy or unresolved skin toxicities

CTCAE grade 1 and/or diarrhoea CTCAE grade 1 caused by prior treatment

with EGFR targeted antibodies.

• Any past or present history of areca/betel-nut chewing or its derivatives for a

cumulative duration of more than 3 months

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Metastatic/Recurrent Head and Neck Squamous Cell Carcinoma.

Intervention(s)

Intervention1: BIBW 2992: Dose: Starting dose 40 mg daily, escalation to 50 mg/day and/or reduction to 40, 30 then 20
mg according to absence or presence of drug related adverse events.

Mode of administration: Oral

Duration: Treatment continued till disease progression or patients tolerate the treatment.
Control Intervention1: Methotrexate: Methotrexate dose: 40 mg/m2/ week with an option to escalate to 50 mg/m2/ week and/or to reduce to 40,
30 then 20 mg/m2/ week according to drug related adverse events.

Mode of Administration: Intravenous bolus injection

Duration: Treatment continued till disease progression or patients tolerate the treatment.

Primary Outcome(s)

Progression free survival (PFS) based on RECIST version 1.1Timepoint: At screening (within 21 days prior to start of treatment (Visit 2) is

accepted if compliant with central imaging requirements)

â?? Every 6 weeks after Visit 2

â?? Every 8 weeks after treatment week 24.

Secondary Outcome(s)

Overall survival (OS)

Timepoint: Every 4 weeks after last Follow-up visit

Objective response based on RECIST version 1.1Timepoint: At screening (within 21 days prior to start of treatment (Visit 2) is

accepted if compliant with central imaging requirements)

â?? Every 6 weeks after Visit 2

â?? Every 8 weeks after treatment week 24.

Health related quality of life (HRQOL)Timepoint: Every 8 weeks while on treatment

Secondary ID(s)

CT/40/13-DCG(I)

1200.161 Version 1.0 dated 07-Feb-2013

Source(s) of Monetary Support

Sponsor

Ethics review

Status: Approved
Approval date: 01/11/2013
Contact:

Amravati Ethics Committee

Status: Approved
Approval date: 17/12/2013
Contact:

Institutional Ethics Committee, Government Medical College, Nagpur

Status: Approved
Approval date: 17/12/2013
Contact:

Institutional Ethics Committee, Meenakshi Mission Hospital and Research Centre

Status: Approved
Approval date: 20/12/2013
Contact:

Institutional Ethics committee,Deenanath Mangeshkar Hospital and Research Centre

Status: Approved
Approval date: 01/03/2014
Contact:

Ethical Committee, B P Poddar Hospital and Medical Research Ltd

Status: Approved
Approval date: 08/03/2014
Contact:

Institutional Ethics Committee, S.P. Medical College & Associated Group of Hospitals

Status: Approved
Approval date: 03/04/2014
Contact:

Institutional Ethics Committee, MNJ Institute of Oncology & Regional Cancer Centre

Status: Approved
Approval date: 05/04/2014
Contact:

Shatabdi Hospital Ethics Committee

Status: Approved
Approval date: 09/04/2014
Contact:

Institutional Ethics Committee, King Georges Medical University

Status: Approved
Approval date: 26/08/2014
Contact:

Institutional Ethics Committee, Mysore Medical College and Research Institute

Status: Approved
Approval date: 16/06/2015
Contact:

Human Research Ethics Committee of Geetanjali University

Status: Not Approved
Approval date:
Contact:

Institutional Ethics Committee - Pristine Hospital and Research Centre Pvt Ltd

Status: Not Approved
Approval date:
Contact:

Institutional Ethics Committee - Rajiv Gandhi Government General Hospital

Status: Not Approved
Approval date:
Contact:

J K Cancer Institute Ethics Committee

Status: Not Approved
Approval date:
Contact:

Poona Medical Research Foundation

Status: Not Approved
Approval date:
Contact:

SEAROC Ethics Committee