Long Term Safety Observation of Crizotinib in Chinese NSCLC Population

Study Overview
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Brief Summary
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This study is to allow access to crizotinib who were treated in previous Pfizer-sponsored studies in China.

Detailed Description
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This study is a phase 4 study, to continually access Xalkori to Chinese patients who were recruited in previous studies of Crizotinib in China, and only collect the safety data.

Official Title
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AN OPEN-LABEL, SINGLE-ARM STUDY OF THE LONG-TERM SAFETY OF XALKORI (REGISTERED) IN PATIENTS FROM CHINA WITH ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC) HARBORING A TRANSLOCATION OR INVERSION EVENT INVOLVING THE ANAPLASTIC LYMPHOMA KINASE (ALK) OR ROS1 LOCUS WHO HAVE PREVIOUSLY BEEN TREATED ON A STUDY OF XALKORI (REGISTERED)

Conditions
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ALK or ROS1-positive NSCLC

Intervention / Treatment
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* Drug: Crizotinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who were enrolled and treated in Studies A8081005, A8081007, A8081014, A8081029, or A8081063 and are still receiving crizotinib treatment at the time of enrollment into this study. OR Patients randomized to the chemotherapy arm in Studies A8081014 or A8081029 who have experienced investigator assessed disease progression and have not yet crossed over to receive crizotinib treatment. No ongoing NCI CTCAE Grade 3 or intolerable Grade 2 adverse events considered to be related to crizotinib treatment Eastern Cooperative Oncology Group (ECOG) performance status 0-3 Adequate organ function as defined by the following criteria Exclusion Criteria: Use of any anticancer drug subsequent to crizotinib prior to study entry Use of drugs or foods that are known potent Cytochrome P450 (CYP)3A4 inhibitors Use of drugs that are known potent CYP3A4 inducers Concurrent use of drugs that are CYP3A4 substrates with narrow therapeutic indices, associated with life threatening arrhythmias

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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: single arm, open label study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: single arm<br>Crizotinib | Drug: Crizotinib<br>* receive crizotinib orally<br>* Other names: Xalkori;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| long term safety of crizotinib in patients with advanced NSCLC harboring a translocation or inversion of the ALK gene or ROS1 gene locus | All SAEs，all AEs leading to permanent treatment discontinuation, and all grades 3-5 AEs as assessed by CTCAE v4.03 | Baseline up to 7 years | 

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