Study to IDEntify Patients With Advanced/Metastatic Non Small Cell Lung Cancer (NSCLC) and ALK and ROS1 Translocation and to Establish Their Therapeutic Management (IDEALK&ROS)

Study Overview
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Brief Summary
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Prospective observational study to IDEntify patients with advanced/metastatic NSCLC and ALK and ROS1 translocation and to establish their therapeutic management (IDEALK&ROS)

Official Title
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Observational Study to IDEntify Patients With Advanced/Metastatic NSCLC and ALK and ROS1 Translocation and to Establish Their Therapeutic Management (IDEALK&ROS)

Conditions
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Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Crizotinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Advanced or metastatic non-small cell lung cancer Patients who will be screened for anaplastic lymphoma kinase (ALK) rearrangement Age > 18 years For the patients that will be recruited prospectively: Patients must have a signed informed consent document. For the treatment sub-study, patients must also meet the following criteria Confirmed anaplastic lymphoma kinase (ALK)-positive tumour Patients treated with crizotinib under routine clinical practice Patients with a minimum data registered at the medical history For the ROS1 treatment sub-study: Confirmation of NSCLC with ROS1-positive translocation Have been eligible to receive treatment with crizotinib according to routine clinical practice since the market launch of the ROS1 indication in Spain on 8 February 2017 until the opening of the site. Patients should have a predetermined minimum amount of data recorded in their medical records. Exclusion Criteria: Any patient who does not meet any of the inclusion criteria defined in the previous section, depending on the sub-study for which they are included.

Ages Eligible for Study
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Minimum Age: 19 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 |
| --- | --- |
| Routine clinical practice group (NSCLC ALK+, ROS1)<br>Patients diagnosed and treated following routine clinical practice, for their NSCLC ALK+ or ROS1 | Drug: Crizotinib<br>* Treatment with crizotinib following routine clinical practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of ALK-positive NSCLC in Spain | Real incidence of ALK-positive NSCLC in Spain | 2 years | 
| Progression Free Survival [PFS] | Efficacy in terms of PFS of Crizotinib in patients with advanced ALK+ and ROS1 translocation NSCLC | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR (Objective Response Rate)_ALK substudy | Percentage of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short aixs was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. | 2 years | 
| Duration of Response (DR)_ALK substudy | Time in weeks/months from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR [which ever occurred first] that was subsequently confirmed plus 1) divided by 7 (or 30.44 if in months). DR was calculated for the subgroup of participants with a confirmed objective tumor response. DR is usually categorized by the median with its 95% Confidence Interval (CI), range and 25% and 75% percentiles. | 2 years | 
| Duration of treatment_ALK substudy | Period of time with Crizotinib treatment | 2 years | 
| Overall Survival (OS) Rate_ALK substudy | Period from the first day of treatment until death or censored up to the last date on which it was known that the subject was alive. | 2 years | 
| Number of Participants With Adverse Events (AEs) According to Seriousness_ALK substudy | Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Seriousness of an AE was assessed under the criteria of serious adverse event (SAE). An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | 2 years | 
| Clinical characteristics | To describe the clinical characteristics of patients with ROS 1 translocation | 2 years | 
| ORR (Objective Response Rate)_ROS 1 substudy | Percentage of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short aixs was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. | 2 years | 
| Duration of Response (DR)_ROS1 substudy | Time in weeks/months from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR [which ever occurred first] that was subsequently confirmed plus 1) divided by 7 (or 30.44 if in months). DR was calculated for the subgroup of participants with a confirmed objective tumor response. DR is usually categorized by the median with its 95% Confidence Interval (CI), range and 25% and 75% percentiles. | 2 years | 
| Duration of treatment_ROS1 substudy | Period of time with Crizotinib treatment | 2 years | 
| Overall Survival (OS) Rate_Ros1substudy | Period from the first day of treatment until death or censored up to the last date on which it was known that the subject was alive. | 2 years | 
| Number of Participants With Adverse Events (AEs) According to Seriousness_Ros1 substudy | Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Seriousness of an AE was assessed under the criteria of serious adverse event (SAE). An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ALK+, ROS1