AzTrials
AzTrials

Carcinoma, Non-Small-Cell LungPhase 3NCT03456076

A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer

A Phase 3 study testing Alectnib, Cisplatin and Vinorelbine in people with Carcinoma, Non-Small-Cell Lung, run by Hoffmann-La Roche at 114 sites in 27 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This randomized, active-controlled, multicenter, open-label, Phase III study is designed to investigate the efficacy and safety of alectinib compared with platinum-based in the adjuvant setting. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Alectnib, Cisplatin and Vinorelbine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
257 participants
Where
114 sitesin 27 countries
Study dates
16 Aug 2018to 19 Nov 2031
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

  • Age ≥18 years
  • Complete resection of histologically confirmed Stage IB (tumor ≥ 4 cm) to Stage IIIA (T2-3 N0, T1-3 N1, T1-3 N2, T4 N0-1) NSCLC as per Union Internationale Contre le Cancer / American Joint Committee on Cancer, 7th edition, with negative margins, at 4-12 weeks before enrollment
  • If mediastinoscopy was not performed preoperatively, it is expected that, at a minimum, mediastinal lymph node systematic sampling will have occurred
  • Documented ALK-positive disease according to an FDA-approved and CE-marked test
  • Eligible to receive a platinum-based chemotherapy regimen according to the local labels or guidelines
  • Eastern Cooperative Oncology Group Performance Status of Grade 0 or 1
Show all 10Show fewer
  • Adequate hematologic and renal function
  • For women of childbearing potential: agreement to remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for at least 90 days after the last dose of alectinib or according to local labels or guidelines for chemotherapy
  • For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm for at least 90 days after the last dose of alectinib or according to local labels or guidelines for chemotherapy. Men must refrain from donating sperm during this same period
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

Who cannot join

  • Pregnant or breastfeeding, or intending to become pregnant during the study or within 90 days after the last dose of alectinib or according to local labels or guidelines for chemotherapy
  • Prior adjuvant radiotherapy for NSCLC
  • Prior exposure to systemic anti-cancer therapy and ALK inhibitors
  • Stage IIIA N2 patients that, in the investigator's opinion, should receive post-operative radiotherapy treatment are excluded from the study
  • Known sensitivity to any component of study drug to which the patient may be randomized. This includes, but is not limited to, patients with galactose intolerance, a congenital lactase deficiency or glucose-galactose malabsorption.
  • Malignancies other than NSCLC within 5 years prior to enrollment, except for curatively treated basal cell carcinoma of the skin, early gastrointestinal (GI) cancer by endoscopic resection, in situ carcinoma of the cervix, ductal carcinoma in situ, papillary thyroid cancer, or any cured cancer that is considered to have no impact on disease free survival or overall survival for the current NSCLC
Show all 15Show fewer
  • Any GI disorder that may affect absorption of oral medications, such as malabsorption syndrome or status post-major bowel resection
  • Liver disease characterized by aspartate transaminase and alanine transaminase >= 3 × upper limit of normal or impaired excretory function or synthetic function or other conditions of decompensated liver disease such as coagulopathy, hepatic encephalopathy, hypoalbuminemia, ascites, or bleeding from esophageal varices or active viral or active autoimmune, alcoholic, or other types of acute hepatitis
  • Japanese patients participating in the serial/intensive PK sample collection only: administration of strong/potent CYP450 3A inhibitors or inducers within 14 days prior to the first dose of study treatment and while on treatment with alectinib up to Week 3
  • Any exclusion criteria based on the local labels or guidelines for chemotherapy regimen
  • Patients with symptomatic bradycardia
  • History of organ transplant
  • Known HIV positivity or AIDS-related illness
  • Any clinically significant concomitant disease or condition that could interfere with-or for which the treatment might interfere with the conduct of the study or the absorption of oral medications or that would pose an unacceptable risk to the patients in this study, in the opinion of the Principal Investigator
  • Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the patient before trial entry

Trial locations and contacts

114 sites in 27 countries.

114 sites in 27 countries

Japan18 sites

  • Aichi Cancer Center

    Aichi, 464-8681

  • National Cancer Center Hospital East

    Chiba, 277-8577

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395

  • Hiroshima University Hospital

    Hiroshima, 734-8551

  • National Hospital Organization Hokkaido Cancer Center

    Hokkaido, 003-0804

  • National Hospital Organization Himeji Medical Center

    Hyōgo, 670-8520

  • Kanagawa Cancer Center

    Kanagawa, 241-8515

  • Kumamoto University Hospital

    Kumamoto, 860-8556

  • Kyoto University Hospital

    Kyoto, 606-8507

  • Sendai Kousei Hospital

    Miyagi, 981-0914

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

  • Okayama University Hospital

    Okayama, 700-8558

  • Osaka City General Hospital

    Osaka, 534-0021

  • Shizuoka Cancer Center

    Shizuoka, 411-8777

  • National Cancer Center Hospital

    Tokyo, 104-0045

  • Juntendo University Hospital

    Tokyo, 113-8431

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550

  • Tokyo Medical University Hospital

    Tokyo, 160-0023

Other trials in Japan

China12 sites

  • Beijing Cancer Hospital

    Beijing, 100142

  • Jilin Cancer Hospital

    Changchun, 132013

  • West China Hospital, Sichuan University

    Chengdu, 610041

  • Fujian Medical University Union Hospital

    Fujian, 350001

  • Guangdong General Hospital

    Guangzhou, 510080

  • Zhejiang Cancer Hospital

    Hangzhou, 310022

  • Shandong Cancer Hospital

    Jinan, 250117

  • Shanghai Chest Hospital

    Shanghai, 200030

  • Zhongshan Hospital Fudan University

    Shanghai, 200032

  • Shenzhen People's Hospital

    Shenzhen, 510852

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430023

  • First Affiliated Hospital of Medical College of Xi'an Jiaotong University

    Xi'an, 710061

Other trials in China

South Korea8 sites

  • National Cancer Center

    Gyeonggi-do, 10408

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620

  • Ajou University Medical Center

    Gyeonggi-do, 16499

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • Korea University Guro Hospital

    Seoul, 08308

Other trials in South Korea

Turkey (Türkiye)8 sites

  • Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital

    Adana, 01250

  • Hacettepe Uni Medical Faculty Hospital

    Ankara, 06100

  • Ankara Ataturk Chest Diseases Training and Research Hospital

    Ankara, 06500

  • Istanbul Uni Cerrahpasa Medical Faculty Hospital

    Istanbul, 34300

  • Ege Uni Medical Faculty Hospital

    Izmir, 35100

  • Izmir Suat Seren Chest Diseases and Surgery Research Hospital

    Izmir, 35110

  • Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

    Malatya, 44280

  • Medikal Park Samsun

    Samsun, 55200

Other trials in Turkey (Türkiye)

Russia7 sites

  • GUZ Regional clinical hospital # 1

    Krasnodar, 350086

  • Moscow City Oncology Hospital #62

    Moscovskaya Oblast, Moscow Oblast, 143423

  • FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF

    Moscow, Moscow Oblast, 115478

  • P.A. Gertsen Cancer Research Inst.

    Moscow, Moscow Oblast, 125284

  • Pavlov First Saint Petersburg State Medical University

    Saint Petersburg, Sankt-Peterburg, 197022

  • SPb City Clin Onc Dsp

    Saint Petersburg, Sankt-Peterburg, 197022

  • Scientific Research Oncology Institute named after N.N. Petrov

    Saint Petersburg, Sankt-Peterburg, 197758

Other trials in Russia

Spain6 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital Universitari Germans Trias i Pujol

    Barcelona, 08916

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

Italy5 sites

  • Irccs Istituto Europeo di Oncologia (IEO)

    Milan, Lombardy, 20141

  • Az. Osp. Monaldi

    Naples, Campania, 80131

  • Azienda Ospedaliero-Universitaria San Luigi Gonzaga

    Orbassano, Piedmont, 10043

  • Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia

    Perugia, Umbria, 06156

  • Azienda Ospedaliera San Camillo Forlanini - Unità Operativa Complessa di Pneumologia Oncologica 1

    Rome, Lazio, 00151

Other trials in Italy

Taiwan5 sites

  • Chang Gung Memorial Foundation - Kaohsiung

    Kaohsiung City, 00833

  • China Medical University Hospital

    Taichung, 40447

  • National Taiwan University Hospital

    Taipei, 10002

  • Chang Gung Medical Foundation - Linkou

    Taoyuan, 333

  • Taichung Veterans General Hospital

    Xitun Dist., 40705

Other trials in Taiwan

Ukraine5 sites

  • Chemotherapy SI Dnipropetrovsk MA of MOHU

    Dnipropetrovsk, 49102

  • Medical center of Yuriy Spizhenko LLC

    Kapitanovka Village, KIEV Governorate, 08112

  • Kyiv City Clinical Oncological Center

    Kyiv, 03115

  • RCI Sumy Regional Clinical Oncological Dispensary

    Sumy, 40005

  • Vinnytsia Regional Clinical Oncology Dispensary

    Vinnytsia, 21029

Other trials in Ukraine

France4 sites

  • CHU Angers

    Angers, 49933

  • Hopital Nord AP-HM

    Marseille, 13015

  • Hopital Bichat Claude Bernard

    Paris, 75018

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Germany4 sites

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09116

  • Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH

    Georgsmarienhütte, 49124

  • Thoraxklinik Heidelberg gGmbH

    Heidelberg, 69126

  • Fachklinik für Lungenerkrankungen

    Immenhausen, 34376

Other trials in Germany

Poland4 sites

  • Gdanski Uniwersytet Medyczny

    Gda?sk, 80-214

  • Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II

    Krakow, 31-202

  • Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie

    Olsztyn, 10-357

  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

    Poznan, 60-569

Other trials in Poland

United States3 sites

  • MGH Cancer Center

    Boston, Massachusetts, 02114

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • AHN Cancer Institute ? Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

Other trials in United States

Australia3 sites

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

  • Peter MacCallum Cancer Center

    Melbourne, Victoria, 3000

  • GenesisCare North Shore

    St Leonards, New South Wales, 2065

Other trials in Australia

Belarus3 sites

  • Healthcare Institution ?Gomel Regional Clinical Oncologic Dispensary?

    Homyel, Homyel'skaya Voblasts', 246012

  • Healthcare Institution Grodno University Hospital

    Hrodna, Grodnenskaya, 230030

  • Vitebsk Regional Clinical Oncology Dispensary

    Vitebsk, Vitebsk Oblast, BU-210603

Other trials in Belarus

Greece2 sites

  • Metropolitan Hospital

    Athens, 185 47

  • Theageneio Hospital

    Thessaloniki, 54007

Other trials in Greece

Hungary2 sites

  • Orszagos Onkologiai Intezet

    Budapest, 1122

  • Hetenyi Geza County Hospital

    Szolnok, 5004

Other trials in Hungary

Israel2 sites

  • Rambam Health Care Campus

    Haifa, 3109601

  • Meir Medical Center

    Kfar Saba, 44281

Other trials in Israel

North Macedonia2 sites

  • PHI University Clinic of Radiotherapy and Oncology; Malignant diseases of thorax

    Skopje, 1000

  • Private Health Organization Acibadem Sistina Hospital

    Skopje, 1000

Other trials in North Macedonia

Romania2 sites

  • Prof Dr I Chiricuta Institute of Oncology

    Cluj-Napoca, 400015

  • Oncomed SRL

    Timișoara, 300239

Other trials in Romania

Thailand2 sites

  • Ramathibodi Hospital

    Bangkok, 10400

  • Siriraj Hospital

    Bangkok, 10700

Other trials in Thailand

United Kingdom2 sites

  • Guys Hospital

    London, SE1 9RY

  • Wythenshaw Hospital

    Manchester, M23 9QZ

Other trials in United Kingdom

Austria1 site

  • Krankenhaus Nord - Klinik Floridsdorf

    Vienna, 1210

Other trials in Austria

Bosnia and Herzegovina1 site

  • Clinical center University of Sarajevo

    Sarajevo, 71000

Other trials in Bosnia and Herzegovina

Denmark1 site

  • Odense Universitetshospital, Onkologisk Afdeling R

    Odense C, 5000

Other trials in Denmark

Egypt1 site

  • Kasr Eieny Uni Hospital

    Cairo, 11555

Other trials in Egypt

Kazakhstan1 site

  • Almaty Oncology Center

    Almaty, 050054

Other trials in Kazakhstan

About this study

Official title: A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With Completely Resected Stage IB (Tumors Equal to or Larger Than 4cm) to Stage IIIA Anaplastic Lymphoma Kinase Positive Non-Small Cell Lung Cancer

This randomized, active-controlled, multicenter, open-label, Phase III study is designed to investigate the efficacy and safety of alectinib compared with platinum-based in the adjuvant setting. Participants in the experimental arm will receive alectinib at 600 mg orally twice daily (BID) taken with food for 24 months.

Participants in the control arm will receive one of the protocol specified platinum based chemotherapy regimens for 4 cycles. Following treatment completion, participants will be followed up for their disease until disease recurrence. At the time of disease recurrence, participants will enter a survival follow-up until death, withdrawal of consent or study closure, whichever occurs earlier.

Being tested
Alectnib, Cisplatin, Vinorelbine, Gemcitabine, Pemetrexed
Keywords
NSCLC, alectinib, ALK positive,adjuvant treatment, platinum based chemotherapy, complete resection, Stage IB-IIIA.
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • AlectnibDrug

    Also called RO5424802

    Participants will receive alectinib 600 mg orally BID until completion of treatment period (24 months) or recurrence of disease , unacceptable toxicity, withdrawal of consent or death, whichever occurs first.

  • CisplatinDrug

    Participants will receive Cisplatin 75 milligrams per square meter (mg/m^2) on Day 1 every 21 days IV intravenously (IV) until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first."

  • VinorelbineDrug

    Also called Navelbine

    Participants will receive Vinorelbine 25 mg/m^2 IV on Days 1 and 8 Q21D until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first.

  • GemcitabineDrug

    Also called Gitrabin

    Participants will receive Gemcitabine 1250 mg/m^2 on Days 1 and 8 Q21D IV until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first.

  • PemetrexedDrug

    Also called Alimta®

    Participants will receive 500 mg/m^2 Day 1 Q21D until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first."

  • CarboplatinDrug

    For participants who experience unacceptable toxicity with cisplatin, carboplatin can be used.

Study groups in NCT03456076
Study groupRoleWhat they receive
AlectinibExperimentalNot described
Receives: Drug: Alectnib
Platinum-Based ChemotherapyActive comparatorNot described
Receives: Drug: Cisplatin; Drug: Vinorelbine; Drug: Gemcitabine; Drug: Pemetrexed; Drug: Carboplatin

What is being measured

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

  1. Disease-free Survival (DFS), as Assessed by the Investigator

    DFS, defined as the time from randomization to the first documented recurrence of disease or new primary NSCLC as determined by the investigator through use of an integrated assessment of radiographic data, biopsy sample results (if clinically feasible), and clinical status or death from any cause, whichever occurs first

    Measured: Approximately 58 months

Secondary outcomes (5)

  1. Overall Survival (OS)

    Primary OS analysis at approximately 5 years after FPI and final OS analysis at approximately 8 years after FPI.

    OS, defined as the time from randomization to death from any cause.

    Measured: From the date of randomization until death due to any cause up to approximately 8 years

  2. Percentage of Participants With Adverse Events (AEs)

    An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events.

    Measured: Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles)

  3. AEs Grade 3-5 With a Difference in Incidence Rate of at Least 2% Between Treatment Arms

    An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events.

    Measured: Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles)

  4. Plasma Concentration of Alectinib

    Measured: Predose (2 hours) Week 3 - Week 96

  5. Plasma Concentration of Alectinib Metabolite M4

    Measured: Predose (2 hours) Week 3 - Week 96

Timeline

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

  1. First posted7 Mar 2018
  2. Study start16 Aug 2018
  3. Primary completion26 Jun 2023
  4. Study completion19 Nov 2031 (estimated)

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
257 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03456076
Sponsor's protocol ID
BO40336
Other IDs
2017-004331-37, 2017
Status last verified
Oct 2026
First submitted
6 Mar 2018
Last updated
14 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Publications

  • Dziadziuszko R, Ahn JS, Barlesi F, Solomon BJ, Wu YL, Bondarenko I, Hochmair M, Horinouchi H, Lee DH, Lee JS, Planchard D, Rittmeyer A, Zhong W, Adler L, Archer V, Cardona A, Petric P, Scalori A, Ding B, Mamolo C, Smoljanovic V, Nishio M. Adjuvant alectinib versus chemotherapy in resected ALK-positive non-small-cell lung cancer (ALINA): health-related quality-of-life and safety outcomes from a randomised, open-label, phase 3 trial. Lancet Oncol. 2026 Sep;27(9):1110-1119. doi: 10.1016/S1470-2045(26)00283-4.

    PubMed 42636834

  • Barlesi F, Ahn JS, Solomon BJ, Nishio M, Dziadziuszko R, Lee DH, Lee JS, Zhong W, Horinouchi H, Mao W, Hochmair M, de Marinis F, Migliorino MR, Bondarenko I, Xu T, Bara I, Ding B, Ngiam C, Petric P, Wu YL. Disease characteristics and treatment outcomes in patients with resected early-stage ALK-positive non-small cell lung cancer from the randomized ALINA trial. Lung Cancer. 2026 Jun;216:109385. doi: 10.1016/j.lungcan.2026.109385. Epub 2026 Mar 28.

    PubMed 41996761

  • Wu YL, Dziadziuszko R, Ahn JS, Barlesi F, Nishio M, Lee DH, Lee JS, Zhong W, Horinouchi H, Mao W, Hochmair M, de Marinis F, Migliorino MR, Bondarenko I, Lu S, Wang Q, Lohmann TO, Xu T, Cardona A, Hiles L, Noe J, Solomon BJ. Plain language summary of the ALINA study results: alectinib compared with chemotherapy after surgery in people with ALK-positive non-small cell lung cancer. Future Sci OA. 2025 Dec;11(1):2578145. doi: 10.1080/20565623.2025.2578145. Epub 2025 Nov 11.

    PubMed 41217067

  • Wu YL, Dziadziuszko R, Ahn JS, Barlesi F, Nishio M, Lee DH, Lee JS, Zhong W, Horinouchi H, Mao W, Hochmair M, de Marinis F, Migliorino MR, Bondarenko I, Lu S, Wang Q, Ochi Lohmann T, Xu T, Cardona A, Ruf T, Noe J, Solomon BJ; ALINA Investigators. Alectinib in Resected ALK-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2024 Apr 11;390(14):1265-1276. doi: 10.1056/NEJMoa2310532.

    PubMed 38598794

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Alectnib, Cisplatin and Vinorelbine in people with Carcinoma, Non-Small-Cell Lung, run by Hoffmann-La Roche at 114 sites in 27 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 10 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 114 sites in Japan, China, South Korea, Turkey (Türkiye), Russia and 22 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 26 Aug 2024). 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?

Disease-free Survival (DFS), as Assessed by the Investigator (time frame: Approximately 58 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 NCT03456076, which also lists 4 linked publications.

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 14 Oct 2026.

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