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

N/AActive Not RecruitingNCT04764188

Hoffmann-La Roche800 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

800

Conditions

NSCLC

Interventions

AlectinibDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Investigator-Confirmed Progression-Free Survival (PFS) According to the Local Standard of Care or per Response Evaluation in Solid Tumors (RECIST) - Cohort 1

Time frame: 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)

Investigator-Confirmed PFS According to the Local Standard of Care or per RECIST - Cohort 2

Time frame: 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

Time frame: Up to approximately 1 year

Duration of Next LoT

Time frame: Up to approximately 1 year

Reasons for Discontinuation of Next LoT

Time frame: Up to approximately 1 year

Secondary Outcomes

Time to Loss of Clinical Benefit (TTLCB)

Time frame: 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)

Overall Survival (OS)

Time frame: 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)

Time frame: From the first administration of alectinib to first CR or PR (up to 4 years for Cohort 1 and Cohort 2)

Data from ClinicalTrials.gov

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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

...and 106 more locations