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Head and Neck NeoplasmsPhase 3NCT01856478

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

A Phase 3 study testing Methotrexate and Afatinib in people with Head and Neck Neoplasms, run by Boehringer Ingelheim at 53 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Neoplasms
What is being tested?
Methotrexate and Afatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
340 participants
Where
53 sitesin 8 countries
Study dates
7 Jun 2013to 2 Oct 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

53 sites in 8 countries.

53 sites in 8 countries

China19 sites

  • Beijing Chao-Yang Hospital

    Beijing, 100020

  • Cancer Hospital of Chinese Academy of Medical Science

    Beijing, 100021

  • Navy General Hospital

    Beijing, 100037

  • Peking Union Medical College Hospital

    Beijing, 100730

  • The First Affiliated Hospital Of Bengbu Medical College

    Bengbu, 233004

  • The First Hospital of Jilin University

    Changchun, 130021

  • Sichuan Cancer Hospital

    Chengdu, 610041

  • West China Hospital

    Chengdu, 610042

  • Sun Yat-Sen University Cancer Center

    Guangzhou, 510060

  • Zhejiang Cancer Hospital

    Hangzhou, 310022

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

  • the 81th Hospital of PLA

    Nanjing, 210002

  • Renji Hospital Shanghai Jiaotong Univesrity School of Medicine

    Shanghai, 200001

  • Shanghai Changzheng Hospital

    Shanghai, 200003

  • Shanghai Ninth People's Hospital

    Shanghai, 200011

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

  • Shanghai Ninth People's Hospital

    Shanghai, 200125

  • Wuhan Union Hospital

    Wuhan, 430022

  • Tongji Hospital, Tongji University

    Wuhan, 430030

Other trials in China

India13 sites

  • Sujan Surgical Cancer Hospital

    Amravati, 444606

  • Pristine Hospital

    Bengaluru, 560086

  • Acharya Tulsi Regional Cancer Treatment & Research Institute

    Bikaner, 334001

  • Rajiv Gandhi Government General Hospital

    Chennai, 600003

  • M N J Institute of Oncology and Regional Cancer Centre

    Hyderabad, 500004

  • Geetanjali Medical College and Hospital

    Jaipur, 313002

  • J K Cancer Institute

    Kanpur, 208005

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

    Kolkata, West Bengal, 700053

  • King George Medical University

    Lucknow, 226003

  • Government Medical College & Hospital

    Nagpur, 440009

  • Shatabdi Hospital, Nashik

    Nashik, 422002

  • Ruby Hall Clinic

    Pune, 411001

  • Noble Hospital Pvt Ltd

    Pune, 411013

Other trials in India

South Korea5 sites

  • National Cancer Center

    Goyang, 10408

  • Severance Hospital

    Seoul, 120-752

  • Samsung Medical Center

    Seoul, 135-710

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

    Seoul, 137-701

  • Asan Medical Center

    Seoul, 138-736

Other trials in South Korea

Taiwan4 sites

  • Keelung Chang Gung Memorial Lover's Lake Branch

    Keelung, 204

  • Taichung Veterans General Hospital

    Taichung, 407

  • National Taiwan University Hospital

    Taipei, 100

  • Tri-Service General Hospital

    Taipei, 11490

Other trials in Taiwan

Thailand4 sites

  • Maharaj Nakom Chiangmai Hospital

    Chiang Mai, 50200

  • Srinagarind Hospital

    Muang, 40002

  • Naresuan University Hospital

    Phitsanulok, 65000

  • Songklanagarind Hospital

    Songkhla, 90110

Other trials in Thailand

Egypt3 sites

  • Alexandria Clinical Research Center

    Alexandria, 21131

  • National Cancer Institute, Cairo University

    Cairo, 11796

  • Mansoura University Faculty of Medicine

    Dakahlia, 35516

Other trials in Egypt

Hong Kong3 sites

  • Pamela Youde Nethersole Eastern Hospital

    Hong Kong, 999077

  • Queen Mary Hospital

    Hong Kong, 999077

  • Prince of Wales Hospital

    Shatin, 999077

Other trials in Hong Kong

Philippines2 sites

  • Perpetual Succour Hospital (Cebu)

    Cebu City, 6000

  • St. Luke's Medical Center

    Quezon City, 1102

Other trials in Philippines

About this study

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.

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.

Being tested
Methotrexate, Afatinib
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MethotrexateDrug

    intravenous bolus injection once weekly

  • AfatinibDrug

    oral intake of one film-coated tablet once daily

Study groups in NCT01856478
Study groupRoleWhat they receive
Afatinib 40 mgExperimentalPatients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who progressed after being treated with platinum-based therapy took, orally, once daily one film-coated tablet of afatinib. Patients started with a 40 milligrams (mg) dose which could be escalated to 50 mg and/or reduced to 40 mg, 30 mg, or 20 mg, according to the absence of presence of drug-related adverse events (AEs).
Receives: Drug: Afatinib
Methotrexate 40 mgActive comparatorPatients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who progressed after being treated with platinum-based therapy received once weekly an intravenous bolus injection of methotrexate. Patients started with a 40 milligrams (mg) per square meter of body surface area (m^2) dose which could be escalated to 50 mg/m^2 and/or reduced to 40 mg/m^2, 30 mg/m^2, or 20 mg/m^2, according to the absence of presence of drug-related adverse events (AEs).
Receives: Drug: Methotrexate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    Progression-free survival (PFS) was defined as the time from the date of randomization to the date of disease progression (PD) evaluated according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 (v1.1). or to the date of death from any cause, whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. PFS parameters were calculated based on Kaplan-Meier curves generated for each group.

    Measured: From randomization until disease progression, death, or primary completion date, whichever occurs first. Up to 35 months.

Secondary outcomes (12)

  1. Objective Response (OR)

    Objective response (OR) defined as the number of patients with best overall response of complete response (CR) or partial response (PR), according to RECIST 1.1. Complete response (CR) is defined as the disappearance of all target lesions and partial response (PR) is defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference. Patients who did not show CR or PR were considered non-responders, irrespective of protocol violations or missing data.

    Measured: From randomization until earliest of disease progression, death, or interim cut-off date (11-Apr-2019). Up to 35 months.

  2. Overall Survival (OS)

    Overall survival (OS) defined as the time from the date of randomization to the date of death, regardless of its cause. OS parameters were calculated based on Kaplan-Meier curves generated for each group.

    Measured: From randomization until death. Up to 6 years.

  3. Time to Deterioration in Global Health Status

    Time to deterioration in global health status was defined as the time from randomization to the first decrease of 10 points on the global health/quality of life (QoL) scale. Patients with no deterioration (including those with disease progression) were censored at the last available health-related quality of life (HRQoL) assessment. The global health status (global health/QoL scale) was evaluated using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30), a 30-item instrument designed to measure quality of life in cancer patients. It is composed of the overall health rating and the quality of life rating. The scale ranges from 0 to 100, where a higher score represents better global health status and quality of life.

    Measured: From randomization until the earliest of deterioration, death, discontinuation with death within 4 weeks, or primary analysis date. Up to 30 months.

  4. Time to Deterioration in Pain Symptoms

    Time to deterioration in pain symptoms was defined as the time from randomization to the first decrease of 10 points on the pain scale. Patients with no deterioration (including those with disease progression) were censored at their last available health-related quality of life (HRQoL) assessment. The pain scale was evaluated using the pain module of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Head and Neck Cancer (EORTC QLQ-H\&N35), which is designed to measure quality of life in head and neck cancer patients. It is composed of 4 questions, inquiring about pain in the mouth, pain in the jaw, soreness in the mouth, and a painful throat. The scale ranges from 0 to 100, where a higher score represents a higher symptom burden.

    Measured: From randomization until the earliest of deterioration, death, discontinuation with death within 4 weeks, or primary analysis date. Up to 19 months.

  5. Time to Deterioration in Swallowing

    Time to deterioration in swallowing was defined as the time from randomization to the first decrease of 10 points on the swallowing scale. Patients with no deterioration (including those with disease progression) were censored at their last available health-related quality of life (HRQoL) assessment. The swallowing scale was evaluated using the swallowing module of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Head and Neck Cancer (EORTC QLQ-H\&N35), which is designed to measure swallowing difficulties in head and neck cancer patients. It is composed of 4 questions, inquiring about problems swallowing liquids, pureed food, solid food, and choking when swallowing. The scale ranges from 0 to 100, where a higher score represents greater difficulty in swallowing.

    Measured: From randomization until the earliest of deterioration, death, discontinuation with death within 4 weeks, or primary analysis date. Up to 19 months.

  6. Change in Global Health Status Over Time

    Change in global health status over time was defined as the mean global health/QoL scale score up to the median follow-up time, describing the average global health status derived from the cumulative change over time, measured by the EORTC QLQ-C30. The EORTC QLQ-C30 is a 30-item questionnaire measuring quality of life in cancer patients (0 to 100, higher scores indicate better health/QoL).

    A mixed-effects growth curve model with a piecewise linear profile adjusted for baseline ECOG performance score and prior EGFR-targeted antibody use in R/M HNSCC was used. The change over time was calculated by dividing the area under the estimated growth curve (AUC) up to the median follow-up time by the median follow-up time.

    Timeframe: The model included measures at baseline and at the following timepoints, if available: Week 6, 12, 18, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, individual end of treatment (EOT; up to 36 months), and individual follow-up visit (EOT + 4 weeks, up to 37 months).

    Measured: Mean change over time is reported up to 12 weeks. Detailed time frame in the endpoint description.

  7. Change in Pain Scale Score Over Time

    Change in pain scale score over time was defined as the mean pain scale score up to the median follow-up time, describing the average pain score derived from the cumulative change over time, measured by the EORTC QLQ-H\&N35 pain module. The EORTC QLQ-H\&N35 pain module is a 4-question tool measuring pain in the mouth, jaw, throat, and soreness in the mouth (0 to 100, higher score = greater pain). A longitudinal mixed-effects growth curve model with a piecewise linear profile adjusted for baseline ECOG performance score and prior EGFR-targeted antibody use in R/M HNSCC was used. The change over time was calculated by dividing the area under the estimated growth curve (AUC) up to median follow-up time by the median follow-up time.

    Timeframe: The model included measures at baseline and at, if available: Week 6, 12, 18, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, individual end of treatment (EOT; up to 36 months), and individual follow-up visit (EOT + 4 weeks, up to 37 months).

    Measured: Mean change over time is reported up to 12 weeks. Detailed time frame in the endpoint description.

  8. Change in Swallowing Scale Scores Over Time

    Change in swallowing scale score over time was defined as the mean swallowing scale score up to the median follow-up time, describing the average swallowing score derived from the cumulative change over time. It was assessed by EORTC QLQ-H\&N35 swallowing module, a 4-question tool measuring problems swallowing liquids, pureed food, solid food, and choking when swallowing (0 to 100, higher score = greater difficulty swallowing). A longitudinal mixed-effects growth curve model with a piecewise linear profile adjusted for baseline ECOG and prior EGFR-targeted antibody use in R/M HNSCC was used. The change over time was calculated by dividing the area under the estimated growth curve (AUC) up to median follow-up time by the median follow-up time.

    Timeframe: the model included measures at baseline and at, if available: Week 6, 12, 18, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, individual end of treatment (EOT; up to 36 months), and individual follow-up visit (EOT + 4 weeks, up to 37 months)

    Measured: Mean change over time is reported up to 12 weeks. Detailed time frame in the endpoint description.

  9. Number of Participants With Improvement in Pain Scale Score

    The number of participants with an improvement in pain scale scores is reported. Improvement was defined as a score that increases by at least 10 points (on a 0-100 point scale) from baseline at any time during the study. If a patient did not show improvement, worsening was defined as a 10-point decrease at any time during the study. Patients who neither improve nor worsen were considered stable. The pain scale was assessed using the pain module of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Head and Neck Cancer (EORTC QLQ-H\&N 35). This questionnaire is designed to measure the quality of life in patients with head and neck cancer. It consists of four questions that inquire about pain in the mouth, pain in the jaw, soreness in the mouth, and a painful throat. The scale ranges from 0 to 100, where a higher score indicates a greater symptom burden.

    Measured: Up to 37 months.

  10. Number of Participants With Improvement in Swallowing Scale Score

    The number of participants with an improvement in swallowing scale scores is reported. Improvement was defined as a score that increases by at least 10 points (on a 0-100 point scale) from baseline at any time during the study. If a patient did not show improvement, worsening was defined as a 10-point decrease at any time during the study. Patients who neither improve nor worsen were considered stable. The swallowing scale was assessed using the swallowing module of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Head and Neck Cancer (EORTC QLQ-H\&N 35). This questionnaire is designed to measure swallowing difficulties in patients with head and neck cancer. It consists of four questions that inquire about problems swallowing liquids, pureed food, solid food, and choking when swallowing. The scale ranges from 0 to 100, where a higher score indicates greater difficulty in swallowing.

    Measured: Up to 37 months.

  11. Number of Participants With Improvement in Overall Health Rate of the Global Health Status

    The number of participants with an improvement in the overall health rate of global health status is reported. Improvement was defined as a score that increases by at least 10 points (on a 0-100 point scale) from baseline at any time during the study. If a patient did not show improvement, worsening was defined as a 10-point decrease at any time during the study. Patients who neither improve nor worsen were considered stable. The global health status (global health/QoL scale) was assessed using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30), a 30-item instrument designed to measure quality of life in all cancer patients. It consists of the overall health rating and the quality of life rating. The scale ranges from 0 to 100, where a higher score indicates better global health status and quality of life.

    Measured: Up to 37 months.

  12. Number of Participants With Improvement in Quality of Life Rate of the Global Health Status

    The number of participants with an improvement in the quality of life rating of global health status is reported. Improvement was defined as a score that increases by at least 10 points (on a 0-100 point scale) from baseline at any time during the study. If a patient did not show improvement, worsening was defined as a 10-point decrease at any time during the study. Patients who neither improve nor worsen were considered stable. The global health status (global health/QoL scale) was assessed using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30), a 30-item instrument designed to measure quality of life in all cancer patients. It consists of the overall health rating and the quality of life rating. The scale ranges from 0 to 100, where a higher score indicates better global health status and quality of life.

    Measured: Up to 37 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2013 (estimated)
  2. Study start7 Jun 2013
  3. Primary completion22 Aug 2018
  4. Study completion2 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
340 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01856478
Sponsor's protocol ID
1200.161
Other IDs
1200-0161
Status last verified
Jan 2026
First submitted
15 May 2013
Last updated
12 Jan 2026
Individual data sharing
Yes: Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

Publications

  • Guo Y, Ahn MJ, Chan A, Wang CH, Kang JH, Kim SB, Bello M, Arora RS, Zhang Q, He X, Li P, Dechaphunkul A, Kumar V, Kamble K, Li W, Kandil A, Cohen EEW, Geng Y, Zografos E, Tang PZ. Afatinib versus methotrexate as second-line treatment in Asian patients with recurrent or metastatic squamous cell carcinoma of the head and neck progressing on or after platinum-based therapy (LUX-Head & Neck 3): an open-label, randomised phase III trial. Ann Oncol. 2019 Nov 1;30(11):1831-1839. doi: 10.1093/annonc/mdz388.

    PubMed 31501887

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Methotrexate and Afatinib in people with Head and Neck Neoplasms, run by Boehringer Ingelheim at 53 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in China, India, South Korea, Taiwan, Thailand and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: From randomization until disease progression, death, or primary completion date, whichever occurs first. Up to 35 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01856478, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.

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