Special Drug Use-results Surveillance of Tabrecta Tablets

Study Overview
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Brief Summary
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This study is an uncontrolled, primary data collection-based observational study to be conducted as a central registration system, multicenter special drug-use results surveillance. As an all-case study, this study will collect all patients treated with Tabrecta in a specified post-marketing period. The observation period of each patient is up to 1 year (52 weeks)

Official Title
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Special Drug Use-results Surveillance of Tabrecta Tablets (MET Exon 14 Skipping Mutation-positive Unresectable Advanced/Recurrent Non-small Cell Lung Cancer)

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Tabrecta tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients receiving Tabrecta for MET exon 14 skipping mutation-positive unresectable advanced/recurrent NSCLC during a specified post-marketing period Exclusion Criteria: -

Ages Eligible for Study
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Maximum Age: 99 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 |
| --- | --- |
| Tabrecta tablets<br>Patients administered Tabrecta by prescription | Drug: Tabrecta tablets<br>* There is no treatment allocation. Patients administered Tabrecta by prescription that have started before inclusion of the patient into the study will be enrolled.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse reactions | An adverse reaction is defined as an adverse event that is suspected by the investigator to be causally related to Tabrecta or whose causality is not recorded. | 1 year | 
| Response rate | A response rate is defined as a proportion of patients whose best overall response is CR or PR as assessed by the RECIST version 1.1(Eisenhauer et al. 2009). Patients assessed as not evaluable (NE) will be handled as non-responders, and included in the denominator for the calculation of response rates. | 1 year | 
| Overall survival rate | The Kaplan-Meier method will be used to estimate the survival curve. Overall survival is defined as the duration from the start date of Tabrecta administration to death of any cause. For patients surviving to the end, OS will be censored at the end date of the observation period. | 1 year | 
| Progression-free survival (PFS) | the Kaplan-Meier method will be used to estimate the PFS curve according to RECIST version 1.1 (Eisenhauer et al. 2009). PFS is defined as the duration from the start date of Tabrecta administration to the date of the date of the first PD observed or death of any cause, whichever comes first. For patients without these events, PFS will be censored at the end date of the observation period. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, non-small cell lung cancer, MET exon 14 skipping mutation-positive