Safety And Efficacy Of Crizotinib (Regulatory Post Marketing Commitment Plan)

Study Overview
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Brief Summary
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The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

Detailed Description
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All the patients whom an investigator prescribes Crizotinib (XALKORI) should be registered.

Official Title
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SPECIAL INVESTIGATION OF XALKORI FOR NSCLC (REGULATORY POST MARKETING COMMITMENT PLAN)

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Crizotinib (Xalkori)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All the patients whom an investigator prescribes XALKORI. (Patients need to be administered Crizotinib (XALKORI) in order to be enrolled in this all cases surveillance.) Exclusion Criteria: Patients not administered XALKORI in spite of enrolled.

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 |
| --- | --- |
| Crizotinib (Xalkori)<br> | Drug: Crizotinib (Xalkori)<br>* XALKORI® Capsule 200 mg／XALKORI® Capsule 250 mg This surveillance is all cases surveillance based on Japanese regulation. Frequency and duration are according to Package Insert as follows.  The recommended dose schedule of crizotinib is 250 mg taken orally twice daily. Dosing interruption and/or dose reduction may be required based on patients' clinical status. <br>* Other names: XALKORI® Capsule 200 mg／XALKORI® Capsule 250 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Drug Reactions | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to XALKORI Capsules in a participant who received XALKORI Capsules. A serious ADR was a ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to XALKORI Capsules was assessed by the physician. | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) at 52 Weeks | Clinical effectiveness of XALKORI Capsules was assessed as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or indeterminate by the physician, based on Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1. Overall effectiveness of XALKORI Capsules was determined by the physician based on the best response. Clinical effectiveness rate was ORR, defined as the percentage of subjects achieving CR or PR with best response. The ORR was presented along with the corresponding exact 2-sided 95% confidence interval (CI). | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, All cases surveillance in Japan, ALK-positive unresectable advanced and/or recurrent non-small cell lung cancer