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Clinical Trials in China / NCT04764188
Active, not recruiting Observational

An Observational Study to Evaluate the Real-World Clinical Management and Outcomes of ALK-Positive Advanced NSCLC Participants Treated With Alectinib

NCT04764188 · tracked via the Priya Life Science China tracker
Sponsor
Hoffmann-La Roche
Phase
Observational
Started
2021-05-10
Last updated
2026-07-10

Condition(s) studied

NSCLC

Investigational drug(s) / intervention(s)

Alectinib →

Alectinib: Participants will receive alectinib in accordance with local clinical practice and local labeling.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (116)

FacilityCityRegionStatus
Clinica Adventista Belgrano Ciudad Autonoma Buenos Aires Argentina
Lifehouse Camperdown New South Wales
Liverpool Hospital Liverpool New South Wales
Royal North Shore Hospital St Leonards New South Wales
GenesisCare North Shore St Leonards New South Wales
Flinders Medical Centre Bedford Park South Australia
Peter MacCallum Cancer Center East Melbourne Victoria
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
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

+ 76 more sites — see the full list on the official registry below.

More Hoffmann-La Roche trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04764188 on ClinicalTrials.gov ↗ ← All trials in China