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An Observational Study to Evaluate the Real-World Clinical Management and Outcomes of ALK-Positive Advanced NSCLC Participants Treated With Alectinib
- Non-Small Cell Lung Cancer
Trial Status:
Recruiting
This trial runs in
Cities
- Abu Dhabi
- Ankara
- Barnaul
- Bedford Park
- Beograd
- Bogotá
- Camperdown
- chang-sha-shi
- Chelyabinsk
- Gent
- guang-zhou-shi
- Haifa
- hang-zhou-shi
- Havana
- he-fei-shi
- İstanbul
- Jinan
- Kaunas
- Klagenfurt am Wörthersee
- Krasnoyarsk
- La Habana
- Liverpool
- Lombardy
- Lucca
- Montevideo
- nan-jing-shi
- nan-ning-shi
- Niš
- Padua
- Palermo
- Panamá
- Perugia
- Petah Tikva
- Porto
- Ramat Gan
- Reggio Calabria
- Roma
- Rome
- Saint Petersburg
- Sremska Kamenica
- tai-zhou-shi
- Taiyuan
- Tampere
- Taranto
- Tel Aviv-Yafo
- tian-jin-shi
- Turku
- Tuscany
- Ufa
- Vila Nova de Gaia
- Vilnius
- Wien
- Wuhan
- Xuzhou
- دبي
Trial Identifier:
NCT04764188 MO42122
Trial 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.
Hoffmann-La Roche
Sponsor
NCT04764188 , MO42122
Trial Identifier
Alectinib
Treatments
NSCLC
Condition
Official Title
A Multicenter Non-Interventional Cohort Study to Evaluate the Real-World Clinical Management and Outcomes of Patients Diagnosed With ALK-Positive Advanced NSCLC Treated With Alectinib (ReAlec)
Eligibility Criteria
All
Gender
≥18 Years
Age
No
Healthy Volunteers
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
For the latest version of this information please go to www.forpatients.roche.com