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Targeted pill may outshine chemo after lung cancer surgery

NCT ID NCT03456076

Disease control Sponsor: Hoffmann-La Roche 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 16, 2026 · Updated 2 times

Summary

This study compares a targeted drug (alectinib) taken as a pill for 2 years against standard chemotherapy after surgery for a specific type of lung cancer (ALK-positive). About 257 adults with stage IB to IIIA lung cancer that was fully removed will participate. The goal is to see if alectinib is better at preventing the cancer from coming back.

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

257 people

The number who actually took part.

Started

Aug 2018

Expected to finish

Nov 2031

An estimate. End dates often move.

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.

Key Inclusion Criteria * 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 * 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 Key Exclusion Criteria * 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 * 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

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

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

Carcinoma, non-small-cell lung

Contacts and locations

Locations

  • AHN Cancer Institute ? Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212, United States

  • Aichi Cancer Center

    Aichi, 464-8681, Japan

  • Ajou University Medical Center

    Gyeonggi-do, 16499, South Korea

  • Almaty Oncology Center

    Almaty, 050054, Kazakhstan

  • Ankara Ataturk Chest Diseases Training and Research Hospital

    Ankara, 06500, Turkey (Türkiye)

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Az. Osp. Monaldi

    Naples, Campania, 80131, Italy

  • Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia

    Perugia, Umbria, 06156, Italy

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

    Rome, Lazio, 00151, Italy

  • Azienda Ospedaliero-Universitaria San Luigi Gonzaga

    Orbassano, Piedmont, 10043, Italy

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

    Adana, 01250, Turkey (Türkiye)

  • Beijing Cancer Hospital

    Beijing, 100142, China

  • CHU Angers

    Angers, 49933, France

  • Chang Gung Medical Foundation - Linkou

    Taoyuan, 333, Taiwan

  • Chang Gung Memorial Foundation - Kaohsiung

    Kaohsiung City, 00833, Taiwan

  • Chemotherapy SI Dnipropetrovsk MA of MOHU

    Dnipropetrovsk, 49102, Ukraine

  • China Medical University Hospital

    Taichung, 40447, Taiwan

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128, South Korea

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050, Australia

  • Clinical center University of Sarajevo

    Sarajevo, 71000, Bosnia and Herzegovina

  • Ege Uni Medical Faculty Hospital

    Izmir, 35100, Turkey (Türkiye)

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

    Moscow, Moscow Oblast, 115478, Russia

  • Fachklinik für Lungenerkrankungen

    Immenhausen, 34376, Germany

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

    Xi'an, 710061, China

  • Fujian Medical University Union Hospital

    Fujian, 350001, China

  • GUZ Regional clinical hospital # 1

    Krasnodar, 350086, Russia

  • Gachon University Gil Medical Center

    Incheon, 21565, South Korea

  • Gdanski Uniwersytet Medyczny

    Gda?sk, 80-214, Poland

  • GenesisCare North Shore

    St Leonards, New South Wales, 2065, Australia

  • Guangdong General Hospital

    Guangzhou, 510080, China

  • Guys Hospital

    London, SE1 9RY, United Kingdom

  • Hacettepe Uni Medical Faculty Hospital

    Ankara, 06100, Turkey (Türkiye)

  • Healthcare Institution ?Gomel Regional Clinical Oncologic Dispensary?

    Homyel, Homyel'skaya Voblasts', 246012, Belarus

  • Healthcare Institution Grodno University Hospital

    Hrodna, Grodnenskaya, 230030, Belarus

  • Hetenyi Geza County Hospital

    Szolnok, 5004, Hungary

  • Hiroshima University Hospital

    Hiroshima, 734-8551, Japan

  • Hopital Bichat Claude Bernard

    Paris, 75018, France

  • Hopital Nord AP-HM

    Marseille, 13015, France

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Universitari Germans Trias i Pujol

    Barcelona, 08916, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041, Spain

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

    Malatya, 44280, Turkey (Türkiye)

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Irccs Istituto Europeo di Oncologia (IEO)

    Milan, Lombardy, 20141, Italy

  • Istanbul Uni Cerrahpasa Medical Faculty Hospital

    Istanbul, 34300, Turkey (Türkiye)

  • Izmir Suat Seren Chest Diseases and Surgery Research Hospital

    Izmir, 35110, Turkey (Türkiye)

  • Jilin Cancer Hospital

    Changchun, 132013, China

  • Juntendo University Hospital

    Tokyo, 113-8431, Japan

  • Kanagawa Cancer Center

    Kanagawa, 241-8515, Japan

  • Kasr Eieny Uni Hospital

    Cairo, 11555, Egypt

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09116, Germany

  • Korea University Guro Hospital

    Seoul, 08308, South Korea

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

    Krakow, 31-202, Poland

  • Krankenhaus Nord - Klinik Floridsdorf

    Vienna, 1210, Austria

  • Kumamoto University Hospital

    Kumamoto, 860-8556, Japan

  • Kyiv City Clinical Oncological Center

    Kyiv, 03115, Ukraine

  • Kyoto University Hospital

    Kyoto, 606-8507, Japan

  • MGH Cancer Center

    Boston, Massachusetts, 02114, United States

  • Medical center of Yuriy Spizhenko LLC

    Kapitanovka Village, KIEV Governorate, 08112, Ukraine

  • Medikal Park Samsun

    Samsun, 55200, Turkey (Türkiye)

  • Meir Medical Center

    Kfar Saba, 44281, Israel

  • Metropolitan Hospital

    Athens, 185 47, Greece

  • Moscow City Oncology Hospital #62

    Moscovskaya Oblast, Moscow Oblast, 143423, Russia

  • National Cancer Center

    Gyeonggi-do, 10408, South Korea

  • National Cancer Center Hospital

    Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    Chiba, 277-8577, Japan

  • National Hospital Organization Himeji Medical Center

    Hyōgo, 670-8520, Japan

  • National Hospital Organization Hokkaido Cancer Center

    Hokkaido, 003-0804, Japan

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395, Japan

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH

    Georgsmarienhütte, 49124, Germany

  • Niigata Cancer Center Hospital

    Niigata, 951-8566, Japan

  • Odense Universitetshospital, Onkologisk Afdeling R

    Odense C, 5000, Denmark

  • Okayama University Hospital

    Okayama, 700-8558, Japan

  • Oncomed SRL

    Timișoara, 300239, Romania

  • Orszagos Onkologiai Intezet

    Budapest, 1122, Hungary

  • Osaka City General Hospital

    Osaka, 534-0021, Japan

  • P.A. Gertsen Cancer Research Inst.

    Moscow, Moscow Oblast, 125284, Russia

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

    Skopje, 1000, North Macedonia

  • Pavlov First Saint Petersburg State Medical University

    Saint Petersburg, Sankt-Peterburg, 197022, Russia

  • Peter MacCallum Cancer Center

    Melbourne, Victoria, 3000, Australia

  • Private Health Organization Acibadem Sistina Hospital

    Skopje, 1000, North Macedonia

  • Prof Dr I Chiricuta Institute of Oncology

    Cluj-Napoca, 400015, Romania

  • RCI Sumy Regional Clinical Oncological Dispensary

    Sumy, 40005, Ukraine

  • Ramathibodi Hospital

    Bangkok, 10400, Thailand

  • Rambam Health Care Campus

    Haifa, 3109601, Israel

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • SPb City Clin Onc Dsp

    Saint Petersburg, Sankt-Peterburg, 197022, Russia

  • Samsung Medical Center

    Seoul, 06351, South Korea

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

    Saint Petersburg, Sankt-Peterburg, 197758, Russia

  • Sendai Kousei Hospital

    Miyagi, 981-0914, Japan

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620, South Korea

  • Shandong Cancer Hospital

    Jinan, 250117, China

  • Shanghai Chest Hospital

    Shanghai, 200030, China

  • Shenzhen People's Hospital

    Shenzhen, 510852, China

  • Shizuoka Cancer Center

    Shizuoka, 411-8777, Japan

  • Siriraj Hospital

    Bangkok, 10700, Thailand

  • Taichung Veterans General Hospital

    Xitun Dist., 40705, Taiwan

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550, Japan

  • Theageneio Hospital

    Thessaloniki, 54007, Greece

  • Thoraxklinik Heidelberg gGmbH

    Heidelberg, 69126, Germany

  • Tokyo Medical University Hospital

    Tokyo, 160-0023, Japan

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

    Wuhan, 430023, China

  • Vinnytsia Regional Clinical Oncology Dispensary

    Vinnytsia, 21029, Ukraine

  • Vitebsk Regional Clinical Oncology Dispensary

    Vitebsk, Vitebsk Oblast, BU-210603, Belarus

  • Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie

    Olsztyn, 10-357, Poland

  • West China Hospital, Sichuan University

    Chengdu, 610041, China

  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

    Poznan, 60-569, Poland

  • Wythenshaw Hospital

    Manchester, M23 9QZ, United Kingdom

  • Zhejiang Cancer Hospital

    Hangzhou, 310022, China

  • Zhongshan Hospital Fudan University

    Shanghai, 200032, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.