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

NCT04764188

Active Not RecruitingN/A

Sponsor: Hoffmann-La Roche

Conditions: NSCLC

Interventions: Alectinib

Countries: Argentina, Australia, Austria, Belgium, Bulgaria, Chile, China, Colombia

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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
Locations (116)
  • Ciudad Autonoma Buenos Aires, Argentina
  • Camperdown, New South Wales, Australia
  • Liverpool, New South Wales, Australia
  • St Leonards, New South Wales, Australia
  • St Leonards, New South Wales, Australia
  • Bedford Park, South Australia, Australia
  • East Melbourne, Victoria, Australia
  • Klagenfurt, Austria
  • Vienna, Austria
  • Vienna, Austria
  • Auderghem, Belgium
  • Ghent, Belgium
  • Hasselt, Belgium
  • Kortrijk, Belgium
  • Liège, Belgium
  • Ronse, Belgium
  • Sint-Niklaas, Belgium
  • Burgas, Bulgaria
  • Panagyurishte, Bulgaria
  • Plovdiv, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Santiago, Santiago Metropolitan, Chile
  • Santiago, Chile
  • Changsha, China
  • Guangzhou, China
  • Guangzhou, China
  • Hangzhou, China
  • Hefei, China
  • Jinan, China
  • + 86 more on CT.gov