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LUX-Head&Neck 3: Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy

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ClinicalTrials.gov Identifier: NCT01856478
Recruitment Status : Active, not recruiting
First Posted : May 17, 2013
Last Update Posted : March 2, 2018
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
This randomized, open-label, phase III study will be performed in patients with recurrent and/or metastatic head and neck cancer which has progressed after platinum-based therapy. The objectives of this trial are to compare the efficacy and safety of afatinib versus methotrexate.

Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Drug: methotrexate Drug: afatinib Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : May 23, 2013
Estimated Primary Completion Date : July 2, 2018
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: afatinib
oral intake, once daily
Drug: afatinib
oral intake, once daily
Active Comparator: methotrexate
intravenous bolus injection, once weekly
Drug: methotrexate
intravenous bolus injection, once weekly

Primary Outcome Measures :
  1. progression free survival (PFS), defined as the time from the date of randomization to the date of progression evaluated according to RECIST 1.1 or to the date of death, whichever occurs first [ Time Frame: up to 2 years ]

Secondary Outcome Measures :
  1. Overall survival (OS), defined as the time from the date of randomization to the date of death (regardless of the cause of death) [ Time Frame: up to 3 years ]
  2. Objective response defined as complete response (CR) or partial response (PR) determined by RECIST 1.1 according to the best response to study medication [ Time Frame: up to 2 years ]
  3. Health related quality of life (HRQOL) will be assessed based on patient-reported questionaires [ Time Frame: up to 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, which has recurred/metastasised and is not amenable for salvage surgery or radiotherapy.
  • Documented progressive disease based on investigator assessment according to RECIST, following receipt of a cisplatin and/or carboplatin and/or Nedaplatin based regimen administered for recurrent and/or metastatic disease independent of whether patient progressed during or after platinum based therapy.
  • Measurable disease according to RECIST (version 1.1).
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at Visit 2.
  • Male and female patients age is 18 years or older
  • Signed and dated written informed consent that is in compliance with ICH-GCP and local law.

Exclusion criteria:

  • Progressive disease within three months after completion of curatively intended treatment for locoregionally advanced or for metastatic head and neck squamous cell cancer (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, with the exception of immunotherapy used either before or after platinum based treatment. Re-challenge with the platinum based regimen after a temporary break is considered an additional line regimen only in case of progression within the break.
  • Prior treatment with EGFR-targeted small molecules.
  • Treatment with any investigational drug less than four weeks or anti-cancer therapy less than three weeks prior to randomization (except palliative radiotherapy to bones to alleviate pain).
  • 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.
  • Previous tumour bleeding CTCAE grade =3.
  • Requirement for treatment with any of the prohibited concomitant medications.
  • Major surgical or planned procedure less than four weeks prior to randomization (isolated biopsies are not considered as major surgical procedures).
  • Any other malignancy unless free of disease for at least five years except for:

    • Other HNSCC of a location as described in inclusion criterion number 1
    • Appropriately treated superficial basal cell skin cancer
    • Surgically cured cervical cancer in situ
    • For Korea: endoscopically cured superficial esophageal and/or gastric cancer is allowed
  • Known lesion or signs of brain metastasis.
  • Known pre-existing interstitial lung disease (ILD).
  • Clinically relevant cardiovascular abnormalities, as judged by the investigator, such as, but not limited to, uncontrolled hypertension, congestive heart failure NYHA classification =III, unstable angina, myocardial infarction within six months prior to randomization, or poorly controlled arrhythmia.
  • Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom in the opinion of the investigator, e.g. Crohn's disease, malabsorption or CTCAE grade >1 diarrhoea of any aetiology at randomization.
  • Known HIV, active hepatitis B, active hepatitis C, and/or other known severe infections, including but not limited to tuberculosis, as judged by the investigator.
  • Other significant disease that in the investigator's opinion would exclude the subject from the trial.
  • Screening laboratory values:

    • Absolute neutrophil count (ANC) <1.5x10^9/l
    • Platelet count <75x10^9/l
    • Total bilirubin >1.5 times the upper limit of normal (ULN)
    • Aspartate amino transferase (AST) or alanine amino transferase (ALT) >3 times the ULN (if related to liver metastases >5 times the ULN)
    • Calculated creatinine clearance <50 ml/min (as evidenced by using the Cockcroft-Gault formula).
  • Women of child-bearing potential and men who are able to father a child, unwilling to be abstinent or to use adequate contraception during the trial and for at least six months after end of treatment. Adequate methods of contraception and definition of child-bearing potential.
  • Pregnancy or breast feeding.
  • Known or suspected hypersensitivity to any of the study medications or their excipients.
  • Patients unable to comply with the protocol, in the opinion of the investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01856478

  Hide Study Locations
Beijing Chao-Yang Hospital
Beijing, China, 100020
Cancer Hospital of Chinese Academy of Medical Science
Beijing, China, 100021
Navy General Hospital
Beijing, China, 100037
Peking Union Medical College Hospital
Beijing, China, 100730
Affiliated toumor hospital of bengbu medical college
Bengbu, China, 233004
First Hospital of Jilin University
Changchun, China, 130021
West China Hospital
Chengdu, China, 610042
The Second People's Hospital of Sichuan
Chengdu, China
Sun Yat-Sen University Cancer Center
Guangzhou, China, 510060
The Third Affiliated Hospital of Harbin Medical University
Haerbin, China, 150081
Zhejiang Cancer Hospital
Hangzhou, China, 310022
the 81th Hospital of PLA
Nanjing, China, 210002
Renji Hospital of Shanghai Second Medical University
Shanghai, China, 200001
Shanghai Changzheng Hospital
Shanghai, China, 200003
Shanghai Ninth People's Hospital
Shanghai, China, 200011
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Shanghai Ninth People's Hospital
Shanghai, China, 200125
Wuhan Union Hospital
Wuhan, China, 430022
Tongji Hospital
Wuhan, China, 430030
Alexandria University Hospital
Alexandria, Egypt, 21131
National Cancer Institute, Cairo University
Cairo, Egypt, 11796
Mansoura University Faculty of Medicine
Dakahlia, Egypt, 324
Hong Kong
Pamela Youde Nethersole Eastern Hospital
Hong Kong, Hong Kong
Queen Mary Hospital
Hongkong, Hong Kong
Prince of Wales Hospital
Shatin, Hong Kong
Sujan Surgical Cancer Hospital
Amravati, India, 444606
Pristine Hospital
Bengaluru, India, 560086
Acharya Tulsi Regional Cancer Treatment & Research Institute
Bikaner, India, 334001
Rajiv Gandhi Government General Hospital
Chennai, India, 600003
M N J Institute of Oncology and Regional Cancer Centre
Hyderabad, India, 500004
Geetanjali Medical College and Hospital
Jaipur, India, 313002
J K Cancer Institute
Kanpur, India, 208005
B. P .Poddar Hospital & Medical Research Ltd.
Kolkata, West Bengal, India, 700053
King George Medical University
Lucknow, India, 226003
Government Medical College & Hospital
Nagpur, India, 440009
Shatabdi Hospital, Nashik
Nasik, India, 422002
Ruby Hall Clinic
Pune, India, 411001
Noble Hospital Pvt Ltd
Pune, India, 411013
Korea, Republic of
National Cancer Center
Goyang, Korea, Republic of, 410-769
Severance Hospital
Seoul, Korea, Republic of, 120-752
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
The Catholic University of Korea, Seoul St.Mary's Hospital
Seoul, Korea, Republic of, 137-701
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Perpetual Succour Hospital (Cebu)
Cebu City, Philippines, 6000
St. Luke's Medical Center
Quezon City, Philippines, 1102
Keelung Chang Gung Memorial Lover's Lake Branch
Keelung City, Taiwan, 204
Taichung Veterans General Hospital
Taichung, Taiwan, 407
National Taiwan University Hospital
Taipei, Taiwan, 100
Tri-Service General Hospital
Taipei, Taiwan, 11490
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, Thailand, 50200
Srinagarind Hospital
Muang, Thailand, 40002
Naresuan University Hospital
Phitsanulok, Thailand, 65000
Songklanagarind Hospital
Songkla, Thailand, 90110
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01856478     History of Changes
Other Study ID Numbers: 1200.161
First Posted: May 17, 2013    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors