An Observational Study to Evaluate the Real-World Clinical Management and Outcomes of ALK-Positive Advanced NSCLC Participants Treated With Alectinib
- Registration Number
- NCT04764188
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This study aims to characterize the clinical management and outcomes of participants diagnosed with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) who are being treated with alectinib in real-world clinical practice.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 800
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort 1 Alectinib 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. Cohort 2 Alectinib Participants receiving alectinib as second-line treatment after study enrollment will be followed up for up to 2 years.
- Primary Outcome Measures
Name Time Method Investigator-Confirmed Progression-Free Survival (PFS) According to the Local Standard of Care or per Response Evaluation in Solid Tumors (RECIST) - Cohort 1 From the first administration of alectinib to the date of first documentation of disease progression, or death due to any cause, whichever occurs first (up to 4 years) Reasons for Discontinuation of Next LoT Up to approximately 1 year Duration of Next LoT Up to approximately 1 year Investigator-Confirmed PFS According to the Local Standard of Care or per RECIST - Cohort 2 From the first administration of alectinib to the date of first documentation of disease progression, or death due to any cause, whichever occurs first (up to 2 years) Choice of the Next Line of Treatment (LoT) Post-Alectinib Up to approximately 1 year
- Secondary Outcome Measures
Name Time Method Time to Loss of Clinical Benefit (TTLCB) From the first administration of alectinib to loss of clinical benefit as assessed by the treating physician (up to 4 years for Cohort 1 and 2 years for Cohort 2) Duration of Objective Response (DOR) From first documentation of CR or PR (whichever occurs first) after the first administration of alectinib until death or progressive disease (PD) (up to 4 years for Cohort 1 and 2 years for Cohort 2) Time to Response From the first administration of alectinib to first CR or PR (up to 4 years for Cohort 1 and 2 years for Cohort 2) Overall Survival (OS) From the first administration of alectinib to death from any cause (up to 4 years for Cohort 1 and 2 years for Cohort 2) Objective Response Rate (ORR), Defined as a Complete Response (CR) or Partial Response (PR) From the first administration of alectinib to first CR or PR (up to 4 years for Cohort 1 and Cohort 2) Duration of Disease Control Time from the first administration of alectinib to the first documentation of CR, PR, or stable disease (whichever occurs first), until death or PD (up to 4 years for Cohort 1 and 2 years for Cohort 2) Time to Central Nervous System (CNS) Progression (Cohort 1 Arm A) Time interval from the first administration of alectinib to the date of confirmed CNS metastases in participants with no CNS metastases at baseline (up to 4 years) Disease Control Rate (DCR) At least 12 weeks after the first administration of alectinib (up to 4 years for Cohort 1 and 2 years for Cohort 2) Time to Initiation of Next Line of Treatment (LoT) From the first administration of alectinib to the date of initiation of next LoT or death due to any cause, whichever occurs first (up to 4 years for Cohort 1 and 2 years for Cohort 2) Quality of Life Status Using the EORTC QLQ-LC13 Scores (Cohort 1 Arm A and Cohort 2) At enrollment and every 3 months thereafter (up to 4 years for Cohort 1 and 2 years for Cohort 2) Quality of Life Status Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores At enrollment and every 3 months thereafter (up to 4 years for Cohort 1 and 2 years for Cohort 2)
Trial Locations
- Locations (116)
Clinica Adventista Belgrano
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
Lifehouse
🇦🇺Camperdown, New South Wales, Australia
Liverpool Hospital
🇦🇺Liverpool, New South Wales, Australia
GenesisCare North Shore
🇦🇺St Leonards, New South Wales, Australia
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
🇨🇴Bogota, Colombia
Angiografia del Occidente
🇨🇴Cali, Colombia
Instituto Cancerología Medellin
🇨🇴Medellin, 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
🇮🇱Petach Tikva, Israel
Chaim Sheba Medical Center
🇮🇱Ramat Gan, Israel
Ichilov Sourasky Medical Center
🇮🇱Tel Aviv, Israel
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
🇮🇹Roma, Lazio, Italy
Policlinico Universitario "Agostino Gemelli"
🇮🇹Roma, Lazio, Italy
AZ. Ospedaliera San Giovanni - Addolorata
🇮🇹Roma, Lazio, Italy
A.O. Villa Scassi
🇮🇹Genova, Liguria, Italy
ASST Spedali Civili di Brescia
🇮🇹Brescia, Lombardia, Italy
Asst Di Cremona
🇮🇹Cremona, Lombardia, Italy
A.O.U. Maggiore della Carità
🇮🇹Novara, Piemonte, Italy
Presidio Ospedaliero Centrale
🇮🇹Taranto, Puglia, Italy
Ospedale Oncologico A.Businco
🇮🇹Cagliari, Sardegna, Italy
AO Ospedali Riuniti Villa Sofia-Cervello-Presidio Ospedaliero Cervello
🇮🇹Palermo, Sicilia, Italy
Ospedale San Jacopo
🇮🇹Pistoia, Toscana, Italy
Clinica Oncologica-Ospedali Riuniti Ancona
🇮🇹Torrette, Toscana, Italy
Ospedale Silvestrini
🇮🇹Perugia, Umbria, Italy
University Hospital Medical Center Bezanijska kosa
🇷🇸Belgrade, Serbia
Clinical Center Nis
🇷🇸Nis, Serbia
Institute for pulmonary diseases of Vojvodina
🇷🇸Sremska Kamenica, Serbia
Adana Baskent University Hospital
🇹🇷Adana, Turkey
Gulhane Training and Research Hospital
🇹🇷Ankara, Turkey
Ataturk Sanatoryum Egitim Ve Arastirma Hastanesi
🇹🇷Ankara, Turkey
Gazi University Medical Faculty, Oncology Hospital
🇹🇷Ankara, Turkey
Liv Hospital Ankara
🇹🇷Ankara, Turkey
Ankara City Hospital
🇹🇷Ankara, Turkey
Antalya Training and Research Hospital
🇹🇷Antalya, Turkey
Pamukkale University School Of Medicine
🇹🇷Denizli, Turkey
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
🇹🇷Edirne, Turkey
Kartal Dr Lutfi Kirdar Sehir Hastanesi
🇹🇷Istanbul, Turkey
Medipol University Medical Faculty
🇹🇷Istanbul, Turkey
Prof. Dr. Cemil Tascioglu City Hospital
🇹🇷Istanbul, Turkey
Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi
🇹🇷Izmir, Turkey
Inonu University Medical Faculty of Medicine
🇹🇷Malatya, Turkey
Necmettin Erbakan Üniversitesi Meram T?p Fakültesi Yunus Emre
🇹🇷Meram, Turkey
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
Shanxi Provincial Cancer Hospital
🇨🇳Taiyuan, China
Royal North Shore Hospital
🇦🇺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 am Worthersee, Austria
Klinik Penzing
🇦🇹Wien, Austria
Krankenhaus Nord - Klinik Floridsdorf
🇦🇹Wien, Austria
CHIREC
🇧🇪Auderghem, Belgium
AZ Sint Lucas (Sint Lucas)
🇧🇪Gent, 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
Centro de Estudios Clínicos SAGA
🇨🇱Santiago, Chile
Inst. Nacional Del Torax
🇨🇱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 City, 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
Istituto Oncologico Veneto IRCCS
🇮🇹Padova, 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
Oncosalud Sac
🇵🇪Lima, Peru
Instituto Nacional de Enfermedades Neoplasicas
🇵🇪Lima, Peru
Aliada Centro Oncologico
🇵🇪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
🇷🇴Iasi, Romania
Spitalul Municipal Ploiesti
🇷🇴Ploiesti, Romania
Centrul de Oncologie Oncohelp
🇷🇴Timisoara, Romania
Altai Regional Oncological Center
🇷🇺Barnaul, Altaj, Russian Federation
Bashkirian Republican Clinical Oncology Dispensary
🇷🇺UFA, Baskortostan, Russian Federation
Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky
🇷🇺Krasnoyarsk, Krasnodar, Russian Federation
Chelyabinsk Regional Clinical Oncology Dispensary
🇷🇺Chelyabinsk, Moskovskaja Oblast, Russian Federation
LLC "Oncology scientific centre"
🇷🇺Pesochny, Sankt Petersburg, Russian Federation
Clinic for Pulmonology, Clinical Center of Serbia
🇷🇸Belgrade, Serbia