Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT04317651
Eligibility Criteria:
Inclusion Criteria:
* 1\. Males and Females aged 18 years with diagnosis of advanced or metastatic NSCLC
* 2\. Former participation in the Italian NPU program between December 2010 - April 2013 or receiving crizotinib according to 648 legislative Decrete from April 2013 to February 2015 and thereafter in clinical practice up to December 31st, 2017.
* 3\. Ascertained compliance to the Crizotinib therapy as prescribed by the relevant physician
* 4\. ALK rearrangement report including details of method and cutoff used for ALK testing
* 5\. Data on prior therapies
* 6\. Data on toxicity
* 7\. Data on crizotinib therapy efficacy including response to the therapy and survival
* 8\. Data on site of metastases
* 9\. Availability of archival tissue (not mandatory)
* 10\. Signed Informed Consent for alive and contactable patients
Exclusion Criteria:
* 1\. Lack of clinical data
* 2\. No evidence of ALK rearrangemement
* 3\. Early death defined as fatal outcome within 30 days since the first crizotinib dose
* 4\. Absence of any radiological assessment
* 5\. No data on crizotinib efficacy including survival
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04317651
Study Brief:
Protocol Section:
NCT04317651