An Observational Study to Evaluate the Real-World Clinical Management and Outcomes of ALK-Positive Advanced NSCLC Participants Treated With Alectinib
NCT ID: NCT04764188
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
800 participants
OBSERVATIONAL
2021-05-10
2027-05-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 1
Participants starting alectinib treatment after (Arm A) or before (Arm B) study enrollment as first-line treatment will be followed up for up to 4 years.
Alectinib
Participants will receive alectinib in accordance with local clinical practice and local labeling.
Cohort 2
Participants receiving alectinib as second-line treatment after study enrollment will be followed up for up to 2 years.
Alectinib
Participants will receive alectinib in accordance with local clinical practice and local labeling.
Interventions
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Alectinib
Participants will receive alectinib in accordance with local clinical practice and local labeling.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-LaRoche
Locations
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Clinica Adventista Belgrano
Ciudad Autonoma Buenos Aires, , Argentina
Lifehouse
Camperdown, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
GenesisCare North Shore
St Leonards, New South Wales, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Peter MacCallum Cancer Center
East Melbourne, Victoria, Australia
Klinikum Klagenfurt am Wörtersee
Klagenfurt, , Austria
Klinik Penzing
Vienna, , Austria
Krankenhaus Nord - Klinik Floridsdorf
Vienna, , Austria
CHIREC
Auderghem, , Belgium
AZ Sint Lucas (Sint Lucas)
Ghent, , Belgium
Jessa Zkh (Campus Virga Jesse)
Hasselt, , Belgium
AZ Groeninge
Kortrijk, , Belgium
CHU de Liège
Liège, , Belgium
AZ Glorieux- vzw Werken Glorieux
Ronse, , Belgium
Vitaz
Sint-Niklaas, , Belgium
Complex Oncology Center Burgas
Burgas, , Bulgaria
Multiprofile Hospital for Active Treatment Uni Hospital
Panagyurishte, , Bulgaria
DDODIU-Plovdiv, EOOD
Plovdiv, , Bulgaria
MBAL Serdika EOOD
Sofia, , Bulgaria
Acibadem City Clinic Tokuda
Sofia, , Bulgaria
Inst. Nacional Del Torax
Santiago, Santiago Metropolitan, Chile
Centro de Estudios Clínicos SAGA
Santiago, , Chile
Hu Nan Provincial Cancer Hospital
Changsha, , China
Sun Yet-sen University Cancer Center
Guangzhou, , China
Guangzhou Panyu Central Hospital
Guangzhou, , China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, , China
Anhui Chest Hospital
Hefei, , China
Shandong Cancer Hospital
Jinan, , China
Jiangsu Province Hospital
Nanjing, , China
Guangxi Cancer Hospital of Guangxi Medical University
Nanning, , China
Shanxi Provincial Cancer Hospital
Taiyuan, , China
Taizhou Hospital of Zhejiang Province
Taizhou, , China
Tianjin Cancer Hospital
Tianjin, , China
Tianjin Medical University General Hospital
Tianjin, , China
Union Hospital of Tongji Medical College, Dept. of Cancer Center
Wuhan, , China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, , China
Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
Bogota, D.C., , Colombia
Hospital Universitario San Ignacio
Bogotá, , Colombia
Angiografia del Occidente
Cali, , Colombia
Instituto Cancerología Medellin
Medellín, , Colombia
Clinical Hospital Centre Osijek
Osijek, , Croatia
Clinical Hospital Centre Zagreb
Zagreb, , Croatia
Hospital Hermanos Ameijeiras
La Habana, , Cuba
Instituto Nacional de Oncología y Radiología (INOR)
La Habana, , Cuba
Masaryk?v onkologický ústav
Brno, , Czechia
Fakultni nemocnice Olomouc
Olomouc, , Czechia
Thomayerova nemocnice
Praha 4 - Krc, , Czechia
Tampere University Hospital
Tampere, , Finland
Turku University Hospital
Turku, , Finland
Rambam Health Care Campus
Haifa, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Chaim Sheba Medical Center
Ramat Gan, , Israel
Ichilov Sourasky Medical Center
Tel Aviv, , Israel
Presidio Ospedaliero Centrale
Taranto, Apulia, Italy
Grande Ospedale Metropolitano
Reggio Calabria, Calabria, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
Meldola, Emilia-Romagna, Italy
Fondazione Ptv Policlinico Tor Vergata
Rome, Lazio, Italy
Policlinico Universitario "Agostino Gemelli"
Rome, Lazio, Italy
AZ. Ospedaliera San Giovanni - Addolorata
Rome, Lazio, Italy
A.O. Villa Scassi
Genoa, Liguria, Italy
ASST Spedali Civili di Brescia
Brescia, Lombardy, Italy
Asst Di Cremona
Cremona, Lombardy, Italy
A.O.U. Maggiore della Carità
Novara, Piedmont, Italy
Ospedale Oncologico A.Businco
Cagliari, Sardinia, Italy
AO Ospedali Riuniti Villa Sofia-Cervello-Presidio Ospedaliero Cervello
Palermo, Sicily, Italy
Ospedale San Jacopo
Pistoia, Tuscany, Italy
Clinica Oncologica-Ospedali Riuniti Ancona
Torrette, Tuscany, Italy
Ospedale Silvestrini
Perugia, Umbria, Italy
Istituto Oncologico Veneto IRCCS
Padua, Veneto, Italy
Hospital of Lithuanian University of Health Sciences Kaunas Clinics Public Institution
Kaunas, , Lithuania
National Cancer Institute
Vilnius, , Lithuania
Instituto Oncológico Nacional (ION)
Panama City, , Panama
Aliada Centro Oncologico
Lima, , Peru
Oncosalud Sac
Lima, , Peru
Instituto Nacional de Enfermedades Neoplasicas
Lima, , Peru
Hospital de Sao Joao
Porto, , Portugal
CHVNG/E_Unidade 1
Vila Nova de Gaia, , Portugal
Alba Emergency County Hospital
Alba Iulia, , Romania
Emergency University Bucharest Hospital
Bucharest, , Romania
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
Cluj-Napoca, , Romania
Amethyst Cluj
Cluj-Napoca, , Romania
Institutul Regional de Oncologie Iasi
Iași, , Romania
Spitalul Municipal Ploiesti
Ploieşti, , Romania
Centrul de Oncologie Oncohelp
Timișoara, , Romania
Altai Regional Oncological Center
Barnaul, Altayskiy Kray, Russia
Bashkirian Republican Clinical Oncology Dispensary
Ufa, Bashkortostan Republic, Russia
Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky
Krasnoyarsk, Krasnodarskiy Kray, Russia
Chelyabinsk Regional Clinical Oncology Dispensary
Chelyabinsk, Moscow Oblast, Russia
LLC "Oncology scientific centre"
Pesochny, Sankt-Peterburg, Russia
Clinic for Pulmonology, Clinical Center of Serbia
Belgrade, , Serbia
University Hospital Medical Center Bezanijska kosa
Belgrade, , Serbia
Institute for pulmonary diseases of Vojvodina
Kamenitz, , Serbia
Clinical Center Nis
Niš, , Serbia
Adana Baskent University Hospital
Adana, , Turkey (Türkiye)
Gulhane Training and Research Hospital
Ankara, , Turkey (Türkiye)
Ataturk Sanatoryum Egitim Ve Arastirma Hastanesi
Ankara, , Turkey (Türkiye)
Gazi University Medical Faculty, Oncology Hospital
Ankara, , Turkey (Türkiye)
Liv Hospital Ankara
Ankara, , Turkey (Türkiye)
Ankara City Hospital
Ankara, , Turkey (Türkiye)
Antalya Training and Research Hospital
Antalya, , Turkey (Türkiye)
Pamukkale University School Of Medicine
Denizli, , Turkey (Türkiye)
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
Edirne, , Turkey (Türkiye)
Kartal Dr Lutfi Kirdar Sehir Hastanesi
Istanbul, , Turkey (Türkiye)
Medipol University Medical Faculty
Istanbul, , Turkey (Türkiye)
Prof. Dr. Cemil Tascioglu City Hospital
Istanbul, , Turkey (Türkiye)
Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi
Izmir, , Turkey (Türkiye)
Inonu University Medical Faculty of Medicine
Malatya, , Turkey (Türkiye)
Necmettin Erbakan Üniversitesi Meram T?p Fakültesi Yunus Emre
Meram, , Turkey (Türkiye)
Mediclinic Airport Road Hospital
Abu Dhabi, , United Arab Emirates
Mediclinic City Hospital
Dubai, , United Arab Emirates
Sanatorio CASMU
Montevideo, , Uruguay
Hanoi Oncology Hospital
Hanoi, , Vietnam
K hospital
Hanoi, , Vietnam
Hochiminh city oncology hospital
Hochiminh City, , Vietnam
Countries
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Other Identifiers
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MO42122
Identifier Type: -
Identifier Source: org_study_id
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