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New oral drug takes on standard chemo for head and neck cancer

NCT ID NCT01856478

Disease control Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tested whether the oral drug afatinib works better than the standard injected drug methotrexate for people with advanced head and neck cancer that has worsened after platinum chemotherapy. The study enrolled 340 patients and measured how long they lived without the cancer growing (progression-free survival) and whether tumors shrank. The goal was to see if afatinib could offer a more convenient and effective treatment option.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Afatinib (oral drug) and methotrexate (injected drug)
What this could lead to
If afatinib works better than methotrexate, it could offer a new, more convenient oral treatment option for advanced head and neck cancer that has stopped responding to platinum chemotherapy.
What could go wrong
This is a completed Phase 3 trial, so results are known. Afatinib may not be significantly better than methotrexate, and both drugs have side effects. The study only included certain types of head and neck cancer, so findings may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

340 people

The number who actually took part.

Started

Jun 2013

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

head and neck neoplasm Head and Neck Neoplasms head and neck squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Head and neck neoplasms

Contacts and locations

Locations

  • Acharya Tulsi Regional Cancer Treatment & Research Institute

    Bikaner, 334001, India

  • Alexandria Clinical Research Center

    Alexandria, 21131, Egypt

  • Asan Medical Center

    Seoul, 138-736, South Korea

  • B. P .Poddar Hospital & Medical Research Ltd.

    Kolkata, West Bengal, 700053, India

  • Beijing Chao-Yang Hospital

    Beijing, 100020, China

  • Cancer Hospital of Chinese Academy of Medical Science

    Beijing, 100021, China

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032, China

  • Geetanjali Medical College and Hospital

    Jaipur, 313002, India

  • Government Medical College & Hospital

    Nagpur, 440009, India

  • Harbin Medical University Cancer Hospital

    Harbin, 150081, China

  • J K Cancer Institute

    Kanpur, 208005, India

  • Keelung Chang Gung Memorial Lover's Lake Branch

    Keelung, 204, Taiwan

  • King George Medical University

    Lucknow, 226003, India

  • M N J Institute of Oncology and Regional Cancer Centre

    Hyderabad, 500004, India

  • Maharaj Nakom Chiangmai Hospital

    Chiang Mai, 50200, Thailand

  • Mansoura University Faculty of Medicine

    Dakahlia, 35516, Egypt

  • Naresuan University Hospital

    Phitsanulok, 65000, Thailand

  • National Cancer Center

    Goyang, 10408, South Korea

  • National Cancer Institute, Cairo University

    Cairo, 11796, Egypt

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • Navy General Hospital

    Beijing, 100037, China

  • Noble Hospital Pvt Ltd

    Pune, 411013, India

  • Pamela Youde Nethersole Eastern Hospital

    Hong Kong, 999077, Hong Kong

  • Peking Union Medical College Hospital

    Beijing, 100730, China

  • Perpetual Succour Hospital (Cebu)

    Cebu City, 6000, Philippines

  • Prince of Wales Hospital

    Shatin, 999077, Hong Kong

  • Pristine Hospital

    Bengaluru, 560086, India

  • Queen Mary Hospital

    Hong Kong, 999077, Hong Kong

  • Rajiv Gandhi Government General Hospital

    Chennai, 600003, India

  • Renji Hospital Shanghai Jiaotong Univesrity School of Medicine

    Shanghai, 200001, China

  • Ruby Hall Clinic

    Pune, 411001, India

  • Samsung Medical Center

    Seoul, 135-710, South Korea

  • Severance Hospital

    Seoul, 120-752, South Korea

  • Shanghai Changzheng Hospital

    Shanghai, 200003, China

  • Shanghai Ninth People's Hospital

    Shanghai, 200011, China

  • Shanghai Ninth People's Hospital

    Shanghai, 200125, China

  • Shatabdi Hospital, Nashik

    Nashik, 422002, India

  • Sichuan Cancer Hospital

    Chengdu, 610041, China

  • Songklanagarind Hospital

    Songkhla, 90110, Thailand

  • Srinagarind Hospital

    Muang, 40002, Thailand

  • St. Luke's Medical Center

    Quezon City, 1102, Philippines

  • Sujan Surgical Cancer Hospital

    Amravati, 444606, India

  • Sun Yat-Sen University Cancer Center

    Guangzhou, 510060, China

  • Taichung Veterans General Hospital

    Taichung, 407, Taiwan

  • The Catholic University of Korea, Seoul St.Mary's Hospital

    Seoul, 137-701, South Korea

  • The First Affiliated Hospital Of Bengbu Medical College

    Bengbu, 233004, China

  • The First Hospital of Jilin University

    Changchun, 130021, China

  • Tongji Hospital, Tongji University

    Wuhan, 430030, China

  • Tri-Service General Hospital

    Taipei, 11490, Taiwan

  • West China Hospital

    Chengdu, 610042, China

  • Wuhan Union Hospital

    Wuhan, 430022, China

  • Zhejiang Cancer Hospital

    Hangzhou, 310022, China

  • the 81th Hospital of PLA

    Nanjing, 210002, China

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