Descriptive Observational Study ALK-2016-CPHG

Study Overview
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Brief Summary
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Descriptive Observational Study. Characteristics Of ALK-positive and ROS1-positive Adults Patients Non-Small Cell Lung Cancer (NSCLC) Treated With Crizotinib Within General Hospitals

Detailed Description
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Describe the characteristics of patients treated with crizotinib Describe efficacy, safety, observance and QoL.

Official Title
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CHARACTERISTICS OF ADULT PATIENTS TREATED WITH CRIZOTINIB FOR ADVANCED NON-SMALL-CELL LUNG CANCER (NSCLC) WITH ALK GENE REARRANGEMENT OR ROS1 GENE REARRANGEMENT IN GENERAL HOSPITALS.

Conditions
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NSCLC, Crizotinib, ALK Gene Rearrangement or ROS1 Gene Rearrangement

Participation Criteria
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Eligibility Criteria
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Inclusion criteria Age ≥ 18 years Locally advanced or metastatic NSCLC Patient ALK gene rearrangement or ROS1 gene rearrangement Patient having initiated in the previous 3 months or patient initiating crizotinib treatment regardless of the line of treatment Patient followed up by a physician in a hospital pulmonary medicine department Subject of reproductive age, using an effective method of contraception Patient informed verbally and in writing on the study and having consented to his/her personal data being collected within the scope of the study. Non-inclusion criteria Patient included within the scope of an interventional therapeutic trial Patient not presenting with ALK gene rearrangement or ROS1 gene rearrangement Patient not available for follow-up throughout the duration of the study Patient deemed to be incapable of responding to the study questions for linguistic, cognitive or organisational reasons.

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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographical Characteristics of Participants |  | Baseline up tp Month 18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects using the diagnostic method used to detect ALK (Anaplastic lymphoma kinase) gene rearrangement |  | Baseline | 
| Number of Participants With Clinical Response through Month 18 |  | Month 3, Month 6, Month 9, Month 12, Month 15, Month 18 | 
| Objective Tumor Response |  | Baseline up to month 18 | 
| Progression-Free Survival (PFS) |  | Baseline up to Month 18 | 
| Number of participants with a change from baseline in (QLQ-LC 13) Quality of life Questionnaire for Lung Cancer |  | Baseline through Month 18 | 
| Change from baseline Morisky self-administered questionnaire |  | Baseline through month 18 | 
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerabitly] |  | Time from first dose of study drug though month 18 | 
| Number of subjects using diagnostic method used to detect ROS1 gene rearrangement |  | Baseline | 
| Overall Survival (OS) |  | Baseline , Month 12, Month 18 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-Small Cell Lung Cancer (NSCLC), crizotinib, ALK gene rearrangement or ROS1 gene rearrangement