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

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

This randomised, open-label, phase III study will be performed in patients with R/M head and neck squamous cell carcinoma (HNSCC) who have progressed after platinum-based therapy. The objectives of the trial are to compare the efficacy and safety of afatinib versus methotrexate

Study Overview

• Status: Completed
• Conditions: Head and Neck Neoplasms; Carcinoma, Squamous Cell
• Intervention / Treatment: Drug: Afatinib; Drug: Methotrexate

• Study Type: Interventional
• Enrollment (Actual): 483
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Autonoma de Bs As, Argentina
    • 1200.43.05401 Boehringer Ingelheim Investigational Site
  • Santa Fe, Argentina
    • 1200.43.05402 Boehringer Ingelheim Investigational Site
  • Villa Dominico, Argentina
    • 1200.43.05403 Boehringer Ingelheim Investigational Site
• Austria
  • Leoben, Austria
    • 1200.43.04303 Boehringer Ingelheim Investigational Site
  • Salzburg, Austria
    • 1200.43.04305 Boehringer Ingelheim Investigational Site
  • Wien, Austria
    • 1200.43.04301 Boehringer Ingelheim Investigational Site
• Belgium
  • Bruxelles, Belgium
    • 1200.43.03202 Boehringer Ingelheim Investigational Site
  • Edegem, Belgium
    • 1200.43.03203 Boehringer Ingelheim Investigational Site
  • Gent, Belgium
    • 1200.43.03204 Boehringer Ingelheim Investigational Site
  • Leuven, Belgium
    • 1200.43.03201 Boehringer Ingelheim Investigational Site
• Brazil
  • Barretos, Brazil
    • 1200.43.05504 Boehringer Ingelheim Investigational Site
  • Jau, Brazil
    • 1200.43.05505 Boehringer Ingelheim Investigational Site
  • Passo Fundo, Brazil
    • 1200.43.05507 Boehringer Ingelheim Investigational Site
  • Porto Alegre, Brazil
    • 1200.43.05503 Boehringer Ingelheim Investigational Site
  • Rio de Janeiro, Brazil
    • 1200.43.05502 Boehringer Ingelheim Investigational Site
  • Sao Paulo, Brazil
    • 1200.43.05501 Boehringer Ingelheim Investigational Site
  • Sao Paulo, Brazil
    • 1200.43.05506 Boehringer Ingelheim Investigational Site
• Czechia
  • Olomouc, Czechia
    • 1200.43.04202 Boehringer Ingelheim Investigational Site
  • Prague 2, Czechia
    • 1200.43.04203 Boehringer Ingelheim Investigational Site
  • Prague 8, Czechia
    • 1200.43.04201 Boehringer Ingelheim Investigational Site
• Denmark
  • København Ø, Denmark
    • 1200.43.04501 Boehringer Ingelheim Investigational Site
• France
  • Avignon Cedex 9, France
    • 1200.43.03304 Boehringer Ingelheim Investigational Site
  • Clermont-Ferrand cedex 1, France, 63011
    • 1200.43.03306 Boehringer Ingelheim Investigational Site
  • Dijon Cedex, France
    • 1200.43.03312 Boehringer Ingelheim Investigational Site
  • Lille Cedex, France
    • 1200.43.03303 Boehringer Ingelheim Investigational Site
  • Lyon Cedex, France
    • 1200.43.03301 Boehringer Ingelheim Investigational Site
  • Montpellier cedex 5, France
    • 1200.43.03302 Boehringer Ingelheim Investigational Site
  • Nice cedex 2, France
    • 1200.43.03307 Boehringer Ingelheim Investigational Site
  • Paris Cedex 05, France
    • 1200.43.03314 Boehringer Ingelheim Investigational Site
  • Poitiers, France
    • 1200.43.03305 Boehringer Ingelheim Investigational Site
  • Rouen Cedex 1, France
    • 1200.43.03316 Boehringer Ingelheim Investigational Site
  • Saint Herblain Cedex, France
    • 1200.43.03309 Boehringer Ingelheim Investigational Site
  • Vandoeuvre les Nancy cedex, France
    • 1200.43.03310 Boehringer Ingelheim Investigational Site
  • Villejuif Cedex, France
    • 1200.43.03317 Boehringer Ingelheim Investigational Site
• Germany
  • Aachen, Germany
    • 1200.43.04903 Boehringer Ingelheim Investigational Site
  • Berlin, Germany
    • 1200.43.04902 Boehringer Ingelheim Investigational Site
  • Dresden, Germany
    • 1200.43.04909 Boehringer Ingelheim Investigational Site
  • Essen, Germany
    • 1200.43.04901 Boehringer Ingelheim Investigational Site
  • Hamburg, Germany
    • 1200.43.04905 Boehringer Ingelheim Investigational Site
  • Hannover, Germany
    • 1200.43.04906 Boehringer Ingelheim Investigational Site
  • Jena, Germany
    • 1200.43.04908 Boehringer Ingelheim Investigational Site
  • Leipzig, Germany
    • 1200.43.04904 Boehringer Ingelheim Investigational Site
  • Mannheim, Germany
    • 1200.43.04907 Boehringer Ingelheim Investigational Site
• Greece
  • Haidari, Greece
    • 1200.43.03004 Boehringer Ingelheim Investigational Site
  • Heraklion, Greece
    • 1200.43.03005 Boehringer Ingelheim Investigational Site
  • Thessaloniki, Greece
    • 1200.43.03002 Boehringer Ingelheim Investigational Site
• Israel
  • Haifa, Israel
    • 1200.43.97201 Boehringer Ingelheim Investigational Site
  • Petach Tikva, Israel
    • 1200.43.97203 Boehringer Ingelheim Investigational Site
  • Tel Hashomer, Israel
    • 1200.43.97204 Boehringer Ingelheim Investigational Site
• Italy
  • Aosta, Italy
    • 1200.43.03909 Boehringer Ingelheim Investigational Site
  • Cagliari, Italy
    • 1200.43.03908 Boehringer Ingelheim Investigational Site
  • Confreria (CN), Italy
    • 1200.43.03901 Boehringer Ingelheim Investigational Site
  • Milano, Italy
    • 1200.43.03907 Boehringer Ingelheim Investigational Site
  • Napoli, Italy
    • 1200.43.03903 Boehringer Ingelheim Investigational Site
  • Palermo, Italy
    • 1200.43.03905 Boehringer Ingelheim Investigational Site
  • Savona, Italy
    • 1200.43.03902 Boehringer Ingelheim Investigational Site
  • Taormina (ME), Italy
    • 1200.43.03904 Boehringer Ingelheim Investigational Site
  • Venezia, Italy
    • 1200.43.03906 Boehringer Ingelheim Investigational Site
  • Viterbo, Italy
    • 1200.43.03910 Boehringer Ingelheim Investigational Site
• Japan
  • Aichi, Nagoya, Japan
    • 1200.43.08106 Boehringer Ingelheim Investigational Site
  • Chiba, Kashiwa, Japan
    • 1200.43.08103 Boehringer Ingelheim Investigational Site
  • Ehime, Matsuyama, Japan
    • 1200.43.08108 Boehringer Ingelheim Investigational Site
  • Hyogo, Akashi, Japan
    • 1200.43.08111 Boehringer Ingelheim Investigational Site
  • Hyogo, Kobe, Japan
    • 1200.43.08107 Boehringer Ingelheim Investigational Site
  • Kanagawa, Isehara, Japan
    • 1200.43.08109 Boehringer Ingelheim Investigational Site
  • Miyagi, Natori, Japan
    • 1200.43.08114 Boehringer Ingelheim Investigational Site
  • Osaka, Osaka, Japan
    • 1200.43.08110 Boehringer Ingelheim Investigational Site
  • Shizuoka, Sunto-gun, Japan
    • 1200.43.08105 Boehringer Ingelheim Investigational Site
  • Tochigi, Shimotsuke, Japan
    • 1200.43.08102 Boehringer Ingelheim Investigational Site
  • Tokyo, Koto-ku, Japan
    • 1200.43.08113 Boehringer Ingelheim Investigational Site
  • Tokyo, Meguro-ku, Japan
    • 1200.43.08104 Boehringer Ingelheim Investigational Site
  • Tokyo, Minato-ku, Japan
    • 1200.43.08112 Boehringer Ingelheim Investigational Site
• Mexico
  • Mexico, Mexico
    • 1200.43.05202 Boehringer Ingelheim Investigational Site
• Russian Federation
  • Ivanovo, Russian Federation
    • 1200.43.00704 Boehringer Ingelheim Investigational Site
  • Kurski, Russian Federation
    • 1200.43.00706 Boehringer Ingelheim Investigational Site
  • Moscow, Russian Federation
    • 1200.43.00709 Boehringer Ingelheim Investigational Site
  • Omsk, Russian Federation
    • 1200.43.00703 Boehringer Ingelheim Investigational Site
  • Pyatigorsk, Russian Federation
    • 1200.43.00710 Boehringer Ingelheim Investigational Site
  • St. Petersburg, Russian Federation
    • 1200.43.00707 Boehringer Ingelheim Investigational Site
  • Ufa, Russian Federation
    • 1200.43.00705 Boehringer Ingelheim Investigational Site
• South Africa
  • Cape Town, South Africa
    • 1200.43.02703 Boehringer Ingelheim Investigational Site
  • Kraaifontein, Cape Town, South Africa
    • 1200.43.02704 Boehringer Ingelheim Investigational Site
  • Parktown, Johannesburg, South Africa
    • 1200.43.02701 Boehringer Ingelheim Investigational Site
  • Pretoria, South Africa
    • 1200.43.02702 Boehringer Ingelheim Investigational Site
• Spain
  • Barcelona, Spain
    • 1200.43.03401 Boehringer Ingelheim Investigational Site
  • Barcelona, Spain
    • 1200.43.03404 Boehringer Ingelheim Investigational Site
  • Girona, Spain
    • 1200.43.03405 Boehringer Ingelheim Investigational Site
  • Málaga, Spain
    • 1200.43.03406 Boehringer Ingelheim Investigational Site
  • Salamanca, Spain
    • 1200.43.03402 Boehringer Ingelheim Investigational Site
  • Zaragoza, Spain
    • 1200.43.03403 Boehringer Ingelheim Investigational Site
• Sweden
  • Göteborg, Sweden
    • 1200.43.04602 Boehringer Ingelheim Investigational Site
• Switzerland
  • Basel, Switzerland, 4031
    • 1200.43.04101 Boehringer Ingelheim Investigational Site
  • Bern, Switzerland
    • 1200.43.04102 Boehringer Ingelheim Investigational Site
• United States
  • Illinois
    • Harvey, Illinois, United States
      • 1200.43.00113 Boehringer Ingelheim Investigational Site
    • Peoria, Illinois, United States
      • 1200.43.00106 Boehringer Ingelheim Investigational Site
  • Massachusetts
    • Boston, Massachusetts, United States
      • 1200.43.00110 Boehringer Ingelheim Investigational Site
  • Nebraska
    • Omaha, Nebraska, United States
      • 1200.43.00107 Boehringer Ingelheim Investigational Site
  • New York
    • Stony Brook, New York, United States
      • 1200.43.00105 Boehringer Ingelheim Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States
      • 1200.43.00102 Boehringer Ingelheim Investigational Site
    • Philadelphia, Pennsylvania, United States
      • 1200.43.00103 Boehringer Ingelheim Investigational Site
  • Texas
    • San Antonio, Texas, United States
      • 1200.43.00109 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

1. Histologically or cytologically confirmed R/M HNSCC of the oral cavity, oropharynx, hypopharynx or larynx, not amenable for salvage surgery or radiotherapy
2. Documented progressive disease based on investigator assessment according to Response Evaluation Criteria in Solid Tumours (RECIST) following receipt of at least two cycles of cisplatin or carboplatin administered for R/M disease
3. Measurable disease according to RECIST
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion criteria:

1. Progressive disease within three months of completion of curatively intended treatment for locoregionally advanced or metastatic HNSCC
2. Any other than one previous platinum based systemic regimen given for R/M disease
3. Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules
4. Pregnancy or breast feeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Afatinib (BIBW 2992); Once daily	Drug: Afatinib; Once daily
Active Comparator: Methotrexate; Weekly	Drug: Methotrexate; Weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS) Based on Central Independent Review	PFS was defined as the time from the date of randomisation to disease progression or death, whichever occurred first. The primary analysis of PFS considered PFS events as assessed by central independent review, including all data collected until the study completion date (06 December 2016). The date of disease progression was recorded based on RECIST version 1.1. Unequivocal progression of disease was determined if at least one of the following criteria applied: At least 20% increase in the Sum of Diameters (SoD) of target lesions taking as reference the smallest SoD recorded since the treatment started, together with an absolute increase in the SoD of at least 5 mm; Appearance of one or more new lesions; Unequivocal progression of existing non-target lesions	From randomization until disease progression, death or study completion date (06Dec2016); Up to 60 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Overall survival (OS) was a key secondary endpoint of this trial. OS was defined as the time from randomisation to death (irrespective of the cause of death). Patients for whom there was no evidence of death at the study completion date (06 December 2016) were to be censored on the date that they were last known to be alive.	From randomization until death or study completion date (06Dec2016); Up to 60 months
Objective Response (OR)	OR is defined as the best overall response of complete response (CR) and partial response (PR) according to RECIST version 1.1, CR for target lesions (TL): Disappearance of all target lesions. CR for non-target lesions (NTL): Disappearance of all non-target lesions. All lymph nodes must be non-pathological in size (<10mm short axis). PR for TL: At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. Other factors which add to the overall response of an imaging timepoint as PR are as below:-; CR in TL, but non-CR/Non-Progressive Disease (PD) in NTL leads to PR; CR in TL, but not evaluated NTL leads to PR; PR in TL, but non-PD NTL or not all evaluated NTL leads to PR; All the above scenarios should also satisfy 'No occurrence of new lesions'.	Tumour imaging was to be performed every 6 weeks during the first 24 weeks of treatment, and hereafter every 8 weeks (data cut-off 07May2014); Up to 28 months
Disease Control (DC)	DC is defined as the best overall response of CR, PR, stable disease (SD) and non-CR/non-PD. CR for target lesions (TL): Disappearance of all target lesions. CR for non-target lesions (NTL): Disappearance of all non-target lesions . All lymph nodes must be non-pathological in size (<10mm short axis). PR for TL: At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. Other factors which add to the overall response of an imaging timepoint as PR are as below:-; CR in TL, but non-CR/Non-PD in NTL leads to PR; CR in TL, but not evaluated NTL leads to PR; PR in TL, but non-PD NTL or not all evaluated NTL leads to PR; SD for TL: change in the sum of diameters does not satisfy PR or PD. SD in TL, non-PD in NTL lead to overall response of SD, provided there is no appearance of new lesions.	Tumour imaging was to be performed every 6 weeks during the first 24 weeks of treatment, and hereafter every 8 weeks (data cut-off 07May2014); Up to 28 months
Tumour Shrinkage	Tumour shrinkage, defined as the maximum decrease from baseline in the sum of diameters of the target lesions, as measured by central imaging. The longest diameter of target lesions was recorded, except for lymph nodes, which were measured by their short axis. Negative values indicate a reduction in the sum of target lesion diameters and positive values an increase. Percentage of Participants with Tumour shrinkage as per the categories (>=20% increase, >=0 - <20% increase, >0 - <30% decrease, >=30 - <50% decrease, >=50% decrease) are presented.	Tumour imaging was to be performed every 6 weeks during the first 24 weeks of treatment, and hereafter every 8 weeks (data cut-off 07May2014); Up to 28 months
Health Related Quality of Life (HRQOL)- Change in Pain Scores Over Time	The HRQOL analyses focused on pain, swallowing, and global health status measured by the European Organisation for Research and Treatment of Cancer [EORTC] quality of life questionnaires Core 30 [QLQ-C30], and head and neck cancer specific supplementary module EORTC QLQ-H&N35: Pain scale from H&N35, Swallowing scale from H&N35 and Global health status/QoL scale from C30. Pain scale includes items 31-34 from H&N 35; Swallowing scale includes items 35-38 from H&N35 and Global health status/QoL scale includes items 29-30 from C30. The scores of these scales were averaged from the scores of the component items, transformed and analyzed on 0 - 100 scale. For pain and swallowing scales, higher scores represent worse outcome; for the global health/QoL scale, higher scores represent better outcome. Changes in scores over time were assessed using longitudinal models. The analyses of HRQOL are presented for the 07 May 2014 cut-off date.	From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.
Health Related Quality of Life (HRQOL)- Change in Swallowing Scores Over Time	The HRQOL analyses focused on pain, swallowing, and global health status measured by the European Organisation for Research and Treatment of Cancer [EORTC] quality of life questionnaires Core 30 [QLQ-C30], and head and neck cancer specific supplementary module EORTC QLQ-H&N35: Pain scale from H&N35, Swallowing scale from H&N35 and Global health status/QoL scale from C30. Pain scale includes items 31-34 from H&N 35; Swallowing scale includes items 35-38 from H&N35 and Global health status/QoL scale includes items 29-30 from C30. The scores of these scales were averaged from the scores of the component items, transformed and analyzed on 0 - 100 scale. For pain and swallowing scales, higher scores represent worse outcome; for the global health/QoL scale, higher scores represent better outcome. Changes in scores over time were assessed using longitudinal models. The analyses of HRQOL are presented for the 07 May 2014 cut-off date.	From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.
Health Related Quality of Life (HRQOL)- Change in Global Health Scores Over Time	The HRQOL analyses focused on pain, swallowing, and global health status measured by the European Organisation for Research and Treatment of Cancer [EORTC] quality of life questionnaires Core 30 [QLQ-C30], and head and neck cancer specific supplementary module EORTC QLQ-H&N35: Pain scale from H&N35, Swallowing scale from H&N35 and Global health status/QoL scale from C30. Pain scale includes items 31-34 from H&N 35; Swallowing scale includes items 35-38 from H&N35 and Global health status/QoL scale includes items 29-30 from C30. The scores of these scales were averaged from the scores of the component items, transformed and analyzed on 0 - 100 scale. For pain and swallowing scales, higher scores represent worse outcome; for the global health/QoL scale, higher scores represent better outcome. Changes in scores over time were assessed using longitudinal models. The analyses of HRQOL are presented for the 07 May 2014 cut-off date.	From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.
Status Change in Pain Scale	Distribution of patients with improved, stable or worsened HRQOL: Improvement was defined as a score improved by at least 10 points from baseline (on the 0-100 point scale) at any time during the trial. If a patient had not improved, worsening was defined as a 10-point worsening at any time during the trial. Otherwise, a patient was considered as stable.	From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.
Status Change in Swallowing Scale	Distribution of patients with improved, stable or worsened HRQOL: Improvement was defined as a score improved by at least 10 points from baseline (on the 0-100 point scale) at any time during the trial. If a patient had not improved, worsening was defined as a 10-point worsening at any time during the trial. Otherwise, a patient was considered as stable.	From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.
Status Change in Global Health Status Scale	Distribution of patients with improved, stable or worsened HRQOL: Improvement was defined as a score improved by at least 10 points from baseline (on the 0-100 point scale) at any time during the trial. If a patient had not improved, worsening was defined as a 10-point worsening at any time during the trial. Otherwise, a patient was considered as stable.	From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.
Time to Deterioration in Pain	The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death.	From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.
Time to Deterioration in Swallowing	The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death.	From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.
Time to Deterioration in Global Health Status	The time to deterioration was defined as the time from randomisation to a score decreased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death.	From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

General Publications

• Cohen EEW, Licitra LF, Burtness B, Fayette J, Gauler T, Clement PM, Grau JJ, Del Campo JM, Mailliez A, Haddad RI, Vermorken JB, Tahara M, Guigay J, Geoffrois L, Merlano MC, Dupuis N, Kramer N, Cong XJ, Gibson N, Solca F, Ehrnrooth E, Machiels JH. Biomarkers predict enhanced clinical outcomes with afatinib versus methotrexate in patients with second-line recurrent and/or metastatic head and neck cancer. Ann Oncol. 2017 Oct 1;28(10):2526-2532. doi: 10.1093/annonc/mdx344.
• Clement PM, Gauler T, Machiels JP, Haddad RI, Fayette J, Licitra LF, Tahara M, Cohen EE, Cupissol D, Grau JJ, Guigay J, Caponigro F, de Castro G Jr, de Souza Viana L, Keilholz U, Del Campo JM, Cong XJ, Ehrnrooth E, Vermorken JB; LUX-H&N 1 investigators. Afatinib versus methotrexate in older patients with second-line recurrent and/or metastatic head and neck squamous cell carcinoma: subgroup analysis of the LUX-Head & Neck 1 trial. Ann Oncol. 2016 Aug;27(8):1585-93. doi: 10.1093/annonc/mdw151. Epub 2016 Apr 15.
• Machiels JP, Haddad RI, Fayette J, Licitra LF, Tahara M, Vermorken JB, Clement PM, Gauler T, Cupissol D, Grau JJ, Guigay J, Caponigro F, de Castro G Jr, de Souza Viana L, Keilholz U, Del Campo JM, Cong XJ, Ehrnrooth E, Cohen EE; LUX-H&N 1 investigators. Afatinib versus methotrexate as second-line treatment in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck progressing on or after platinum-based therapy (LUX-Head & Neck 1): an open-label, randomised phase 3 trial. Lancet Oncol. 2015 May;16(5):583-94. doi: 10.1016/S1470-2045(15)70124-5. Epub 2015 Apr 16.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2012
• Primary Completion (Actual): March 15, 2014
• Study Completion (Actual): December 6, 2016

Study Registration Dates

• First Submitted: April 28, 2011
• First Submitted That Met QC Criteria: April 29, 2011
• First Posted (Estimate): May 2, 2011

Study Record Updates

• Last Update Posted (Actual): February 15, 2018
• Last Update Submitted That Met QC Criteria: January 19, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Head and Neck Neoplasms; Carcinoma; Carcinoma, Squamous Cell; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Protein Kinase Inhibitors; Reproductive Control Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Folic Acid Antagonists; Methotrexate; Afatinib
• Other Study ID Numbers: 1200.43; 2011-000391-34 (EudraCT Number: EudraCT)