Study to Evaluate Clinical Real World Outcomes of Lorlatinib After Alectinib in ALK-Positive NSCLC Japanese Patients

Study Overview
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Brief Summary
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To evaluate the clinical real world outcomes of lorlatinib in second/later line setting anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) to TKI sequence sequence treatment after failure of alectinib as a first-line treatment in Japanese ALK positive non-small cell lung cancer (NSCLC).

Detailed Description
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This study is a post-approval, company-sponsored, observational study. This study is a multicenter, non-interventional, retrospective, chart review of patients with ALK+ NSCLC patients treated using lorlatinib as the second/later line therapy in Japan after failure of alectinib treatment as the first line therapy from 20 November 2018. All decisions regarding clinical management and treatment of the participating patients were made by an investigator as part of standard care in real-world clinical setting and were not contingent upon the patient's participation in the study. Data will be collected if available per study site. Patients in this study are those who started treatment with lorlatinib from 1 May 2019 to 31 December, 2020 in clinical practice.

Official Title
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Retrospective, Multicenter, Observational Study to Evaluate Clinical Real World Outcomes of Lorlatinib After Alectinib in ALK-Positive NSCLC Japanese Patients

Conditions
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ALK-positive Non-small-cell Lung Cancer

Intervention / Treatment
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* Drug: Lortlatinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed NSCLC, with any tumor, node and metastasis (TNM) stage. Confirmed ALK gene rearrangement by any validated test. Confirmed the treatment with alectinib in the first line setting as systemic therapy in the medical record. Confirmed the start treatment with lorlatinib as the second/later-line therapy from 1st May 2019 to 31st December 2020. Exclusion Criteria: -Participating on any clinical trials of which final results has not yet been reported during the study period.

Ages Eligible for Study
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Minimum Age: 20 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 |
| --- | --- |
| Japanese patients with ALK+ NSCLC who received lorlatinib<br>lorlatinib as the second-line or later therapy after failure of alectinib treatment as the firstline therapy | Drug: Lortlatinib<br>* as provided in real world practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of patient characteristics at baseline (at the timing of alectinib initiation date) and at lorlatinib initiation date | Age Sex Body mass index (BMI) Eastern Cooperative Oncology Group Performance Status (ECOG PS) NSCLC histopathological subtype Number and site of metastases Complications/medical history (related to history of treatment for ALK+ NSCLC) Smoking history ALK test result (ALK testing method, date of test result/diagnosis and test result) # of treatment regimens administered to the target disease prior to the start of lorlatinib treatment Time-to-treatment failure (TTF) for lorlatinib as the second line and the 3rd/later line | 1 May 2019 to 15 OCT 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Reason for discontinuation of each treatment line therapy | The reasons for discontinuation of each treatment will be categorized as disease progression, adverse events, and others. | 1 May 2019 to 15 OCT 2021 | 
| - Objective response of lorlatinib as the second line and the 3rd/later line | Evaluate Objective Response of lorlatinib as 2nd/3rd or later line in Real World | 1 May 2019 to 15 OCT 2021 | 
| - TTF of alectinib and subsequent therapy except for lorlatinib | Evaluate TTF of alectinib in Real World | 1 May 2019 to 15 OCT 2021 | 
| - Objective response of alectinib | Evaluate Objective Response of alectinib in Real World | 1 May 2019 to 15 OCT 2021 | 
| - Combined TTF | combined TTF will be defined as the sum of alectinib and subsequent therapy including TTF of lorlatinib | 1 May 2019 to 15 OCT 2021 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ALK, Lorlatinib, Alectinib, Real World, retrospective