Description of Clinical Anatomical Features and Long Term Follow-up for Patients With ALK Rearrangements

Study Overview
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Brief Summary
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Description of clinical and anatomical features and long-term follow-up for patients with ALK rearrangement and treated by crizotinib

Detailed Description
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Several French studies on crizotinib have been conducted in recent years. These are not only patients treated in the PROFILE 1005 and 1007 clinical studies but also patients who have been treated with crizotinib in the named patient ATU followed by the cohort ATU (Expended Access Cohort). Under the ATU program and according to ATU regulations, a limited set of data is collected and furthermore the follow up is stopped as soon as the ATU program closes. Thus it is not possible to have access to long term data and post progression data. Our project is to collect data from the patients from the ATU program (named patient and cohort) and if possible patients treated after the marketing of crizotinib, before, during and after crizotinib therapy. Centers selected for this observational study will be those of the IFCT network that took part in the ATU program. This will allow an accurate analysis of crizotinib therapy under real life conditions. It should be emphasized that this information is generally neither available from clinical trials nor from ATU programs.

Official Title
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Description of Clinical Anatomical Features and Long Term Follow-up for Patients With ALK Rearrangements

Conditions
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Non-small Cell Lung Cancer, Anaplastic Lymphoma Kinase Gene Mutation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must have locally advanced or metastatic NSCLC (Stage IIIb or Stage IV by AJCC 7th.) with positive ALK determined by IHC and/or FISH. Patient who received crizotinib on an expanded access basis (compassionate use) (ATU) due to their inability to meet eligibility criteria for on-going recruiting trials, inability to participate in other clinical trials (e.g., poor performance status, lack of geographic proximity), or because other medical interventions are not considered appropriate or acceptable Patient who received marketed crizotinib as a result of the standard care of metastatic NSCLC (Stage IIIb or Stage IV by AJCC 7th.) with positive ALK will also be eligible. Patient was able to swallow capsules and had no surgical or anatomical condition that precluded the patient from swallowing and absorbing oral medications on an ongoing basis. Patient has taken at least 1 week of treatment Exclusion Criteria: Patient included in a crizotinib clinical trial Patient with known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.

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 |
| --- | --- |
| patients ALK + who received crizotinib<br>patients with ALK rearrangement who started treatment with crizotinib (250 mg twice a day) between the 18/11/2010 and the 31/12/2013 (will include patients from the ATU programs and patients treated after the marketing of crizotinib) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | overall survival post-progression on crizotinib | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rare and severe complications of crizotinib therapy | Incidence of rare and severe complications of crizotinib therapy: hepatotoxicity, interstitial pneumonitis, diastolic heart failure | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-squamous non-small cell lung cancer, crizotinib, real-world study, IFCT