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Real-World study tracks Alectinib's performance in advanced lung cancer

NCT ID NCT04764188

Knowledge-focused 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 10, 2026 · Updated 1 time

Summary

This study follows about 800 people with ALK-positive advanced non-small cell lung cancer who are taking the drug alectinib as part of their routine care. Researchers want to see how long the cancer stays under control and how patients are managed in real-world clinics, not just in controlled trials. The goal is to gather practical information that can help doctors make better treatment decisions.

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.

Participants

About 800 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2021

Expected to finish

May 2027

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.

Who is studied

Eligible participants will be identified in real-world clinical settings.

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 * Confirmed diagnosis of advanced NSCLC (stage IIIB, IIIC, IVA, or IVB) on or after the date of local approval for alectinib as first-line treatment and/or second-line treatment for ALK-positive advanced NSCLC and planned to receive treatment as per routine for at least one cycle (28 days) while on study * ALK-positive as confirmed by immunohistochemistry (IHC), fluorescent in situ hybridization (FISH), next generation sequencing (NGS), or other non-specified sequencing methods, documented prior to receiving treatment with an ALK inhibitor * Cohort 1: Currently receiving, or planned to receive, treatment for ALK-positive advanced NSCLC with alectinib as first-line treatment * Cohort 2: Planned to receive treatment for ALK-positive advanced NSCLC with alectinib as second-line treatment * Able to be followed-up by participating site * Participants with advanced NSCLC who have CNS metastases are eligible for inclusion Exclusion Criteria * Participants not receiving alectinib for the treatment of ALK-positive advanced NSCLC according to standard of care and in line with local product information * Participants not receiving the Roche studied medicinal product * Participants who have received or are currently receiving alectinib as an investigational study drug in a clinical trial for the treatment of advanced NSCLC

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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.

NSCLC

Contacts and locations

Locations

  • A.O. Villa Scassi

    Genoa, Liguria, 16149, Italy

  • A.O.U. Maggiore della Carità

    Novara, Piedmont, 28100, Italy

  • AO Ospedali Riuniti Villa Sofia-Cervello-Presidio Ospedaliero Cervello

    Palermo, Sicily, 90146, Italy

  • ASST Spedali Civili di Brescia

    Brescia, Lombardy, 25123, Italy

  • AZ Glorieux- vzw Werken Glorieux

    Ronse, 9600, Belgium

  • AZ Groeninge

    Kortrijk, 8500, Belgium

  • AZ Sint Lucas (Sint Lucas)

    Ghent, 9000, Belgium

  • AZ. Ospedaliera San Giovanni - Addolorata

    Rome, Lazio, 00184, Italy

  • Acibadem City Clinic Tokuda

    Sofia, Bulgaria

  • Adana Baskent University Hospital

    Adana, 01120, Turkey (Türkiye)

  • Alba Emergency County Hospital

    Alba Iulia, 510077, Romania

  • Aliada Centro Oncologico

    Lima, 15036, Peru

  • Altai Regional Oncological Center

    Barnaul, Altayskiy Kray, 656049, Russia

  • Amethyst Cluj

    Cluj-Napoca, Romania

  • Angiografia del Occidente

    Cali, 760045, Colombia

  • Anhui Chest Hospital

    Hefei, China

  • Ankara City Hospital

    Ankara, 06800, Turkey (Türkiye)

  • Antalya Training and Research Hospital

    Antalya, 07100, Turkey (Türkiye)

  • Asst Di Cremona

    Cremona, Lombardy, 26100, Italy

  • Ataturk Sanatoryum Egitim Ve Arastirma Hastanesi

    Ankara, 06280, Turkey (Türkiye)

  • Bashkirian Republican Clinical Oncology Dispensary

    Ufa, Bashkortostan Republic, 450054, Russia

  • CHIREC

    Auderghem, 1160, Belgium

  • CHU de Liège

    Liège, 4000, Belgium

  • CHVNG/E_Unidade 1

    Vila Nova de Gaia, 4434-502, Portugal

  • Centro de Estudios Clínicos SAGA

    Santiago, 7500653, Chile

  • Centrul de Oncologie Oncohelp

    Timișoara, 300239, Romania

  • Chaim Sheba Medical Center

    Ramat Gan, 5262100, Israel

  • Chelyabinsk Regional Clinical Oncology Dispensary

    Chelyabinsk, Moscow Oblast, 454087, Russia

  • Clinic for Pulmonology, Clinical Center of Serbia

    Belgrade, 11000, Serbia

  • Clinica Adventista Belgrano

    Ciudad Autonoma Buenos Aires, C1430EGF, Argentina

  • Clinica Oncologica-Ospedali Riuniti Ancona

    Torrette, Tuscany, 60020, Italy

  • Clinical Center Nis

    Niš, 18 000, Serbia

  • Clinical Hospital Centre Osijek

    Osijek, 31000, Croatia

  • Clinical Hospital Centre Zagreb

    Zagreb, 10000, Croatia

  • Complex Oncology Center Burgas

    Burgas, Bulgaria

  • DDODIU-Plovdiv, EOOD

    Plovdiv, 4004, Bulgaria

  • Emergency University Bucharest Hospital

    Bucharest, 050098, Romania

  • Fakultni nemocnice Olomouc

    Olomouc, 775 20, Czechia

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042, Australia

  • Fondazione Ptv Policlinico Tor Vergata

    Rome, Lazio, 00133, Italy

  • Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo

    Bogota, D.C., 110131, Colombia

  • Gazi University Medical Faculty, Oncology Hospital

    Ankara, 06500, Turkey (Türkiye)

  • GenesisCare North Shore

    St Leonards, New South Wales, 2065, Australia

  • Grande Ospedale Metropolitano

    Reggio Calabria, Calabria, 89133, Italy

  • Guangxi Cancer Hospital of Guangxi Medical University

    Nanning, 530021, China

  • Guangzhou Panyu Central Hospital

    Guangzhou, China

  • Gulhane Training and Research Hospital

    Ankara, 06010, Turkey (Türkiye)

  • Hanoi Oncology Hospital

    Hanoi, 100000, Vietnam

  • Hochiminh city oncology hospital

    Hochiminh City, 700000, Vietnam

  • Hospital Hermanos Ameijeiras

    La Habana, 10300, Cuba

  • Hospital Universitario San Ignacio

    Bogotá, 000472, Colombia

  • Hospital de Sao Joao

    Porto, 4200, Portugal

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics Public Institution

    Kaunas, 50009, Lithuania

  • Hu Nan Provincial Cancer Hospital

    Changsha, 410006, China

  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola

    Meldola, Emilia-Romagna, 47014, Italy

  • Ichilov Sourasky Medical Center

    Tel Aviv, 6423906, Israel

  • Inonu University Medical Faculty of Medicine

    Malatya, 44280, Turkey (Türkiye)

  • Inst. Nacional Del Torax

    Santiago, Santiago Metropolitan, 7500691, Chile

  • Institute for pulmonary diseases of Vojvodina

    Kamenitz, 21204, Serbia

  • Instituto Cancerología Medellin

    Medellín, 050024, Colombia

  • Instituto Nacional de Enfermedades Neoplasicas

    Lima, Lima 34, Peru

  • Instituto Nacional de Oncología y Radiología (INOR)

    La Habana, 10400, Cuba

  • Instituto Oncológico Nacional (ION)

    Panama City, 0816-04433, Panama

  • Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca

    Cluj-Napoca, 400015, Romania

  • Institutul Regional de Oncologie Iasi

    Iași, 700483, Romania

  • Istituto Oncologico Veneto IRCCS

    Padova, Veneto, 35128, Italy

  • Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi

    Izmir, 35110, Turkey (Türkiye)

  • Jessa Zkh (Campus Virga Jesse)

    Hasselt, 3500, Belgium

  • Jiangsu Province Hospital

    Nanjing, 210036, China

  • K hospital

    Hanoi, 100000, Vietnam

  • Kartal Dr Lutfi Kirdar Sehir Hastanesi

    Istanbul, 34000, Turkey (Türkiye)

  • Klinik Penzing

    Vienna, 1140, Austria

  • Klinikum Klagenfurt am Wörtersee

    Klagenfurt, 9020, Austria

  • Krankenhaus Nord - Klinik Floridsdorf

    Vienna, 1210, Austria

  • Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky

    Krasnoyarsk, Krasnodarskiy Kray, 660133, Russia

  • Lifehouse

    Camperdown, New South Wales, 2050, Australia

  • Liv Hospital Ankara

    Ankara, 06680, Turkey (Türkiye)

  • Liverpool Hospital

    Liverpool, New South Wales, 2170, Australia

  • MBAL Serdika EOOD

    Sofia, 1632, Bulgaria

  • Masaryk?v onkologický ústav

    Brno, 656 53, Czechia

  • Medical Clinic "AB Medical group"

    Saint Petersburg, Sankt-Peterburg, 196006, Russia

  • Mediclinic Airport Road Hospital

    Abu Dhabi, United Arab Emirates

  • Mediclinic City Hospital

    Dubai, 31500, United Arab Emirates

  • Medipol University Medical Faculty

    Istanbul, 34214, Turkey (Türkiye)

  • Multiprofile Hospital for Active Treatment Uni Hospital

    Panagyurishte, 4500, Bulgaria

  • National Cancer Institute

    Vilnius, LT-08660, Lithuania

  • Necmettin Erbakan Üniversitesi Meram T?p Fakültesi Yunus Emre

    Meram, 42080, Turkey (Türkiye)

  • Oncosalud Sac

    Lima, 41, Peru

  • Ospedale Oncologico A.Businco

    Cagliari, Sardinia, 09121, Italy

  • Ospedale San Jacopo

    Pistoia, Tuscany, 51100, Italy

  • Ospedale Silvestrini

    Perugia, Umbria, 06122, Italy

  • Pamukkale University School Of Medicine

    Denizli, 20070, Turkey (Türkiye)

  • Peter MacCallum Cancer Center

    East Melbourne, Victoria, 3002, Australia

  • Policlinico Universitario "Agostino Gemelli"

    Rome, Lazio, 00168, Italy

  • Presidio Ospedaliero Centrale

    Taranto, Apulia, 74121, Italy

  • Prof. Dr. Cemil Tascioglu City Hospital

    Istanbul, 34384, Turkey (Türkiye)

  • Rabin Medical Center

    Petah Tikva, 4941492, Israel

  • Rambam Health Care Campus

    Haifa, 3109601, Israel

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065000, Australia

  • Sanatorio CASMU

    Montevideo, Uruguay

  • Shandong Cancer Hospital

    Jinan, 250117, China

  • Shanxi Provincial Cancer Hospital

    Taiyuan, 030013, China

  • Spitalul Municipal Ploiesti

    Ploieşti, 100337, Romania

  • Sun Yet-sen University Cancer Center

    Guangzhou, 510060, China

  • Taizhou Hospital of Zhejiang Province

    Taizhou, China

  • Tampere University Hospital

    Tampere, 33520, Finland

  • The Affiliated Hospital of Xuzhou Medical College

    Xuzhou, 221004, China

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, 310009, China

  • Thomayerova nemocnice

    Praha 4 - Krc, 140 59, Czechia

  • Tianjin Cancer Hospital

    Tianjin, 300060, China

  • Tianjin Medical University General Hospital

    Tianjin, China

  • Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

    Edirne, 22030, Turkey (Türkiye)

  • Turku University Hospital

    Turku, 20521, Finland

  • Union Hospital of Tongji Medical College, Dept. of Cancer Center

    Wuhan, 430023, China

  • University Hospital Medical Center Bezanijska kosa

    Belgrade, 11080, Serbia

  • Vitaz

    Sint-Niklaas, 9100, Belgium

More trials for these conditions

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