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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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NSCLC

Intervention / Treatment
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* Drug: Alectinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Participants starting alectinib treatment before (Arm A) or after (Arm B) study enrollment as first-line treatment will be followed up for up to 4 years. | Drug: Alectinib<br>* Participants will receive alectinib in accordance with local clinical practice and local labeling.<br>|
| Cohort 2<br>Participants receiving alectinib as second-line treatment after study enrollment will be followed up for up to 2 years. NOTE: Enrollment to this cohort has been ended. | Drug: Alectinib<br>* Participants will receive alectinib in accordance with local clinical practice and local labeling.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 | 
| Duration of Next LoT |  | Up to approximately 1 year | 
| Reasons for Discontinuation of Next LoT |  | Up to approximately 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ALK-positive NSCLC