Safety and effectiveness of LORLAtinib as a FIRST-line treatment in an ALK-positive Advanced Non-Small Cell Lung Cancer Spanish population. (LORLA-FIRST).

ENCePP Code of conduct

N/A

Data sources

• Data source(s), other:
  The investigators will collect the data of the patients included in an electronic data collection form (e-CRF) designed specifically for this study and developed by the CRO in charge at the beginning of the study. ; The data will be stored in an access database protected by password and only accessible to authorized personnel. ; Descriptive and survival analyses will be performed to evaluate the study objectives, using the Kaplan-Meier method and the Cox model. ; The AEs will be summarized by presenting the frequency distribution and percentage of these in the total number of patients and will be coded according to the CTCAE v6.0.; Brain MRI will be collected at baseline and in case of CNS toxicity. ; Images will be anonymized and centrally analyzed to assess Fazekas scale, morphometric and radiomic features that will be correlated with CNS toxicity.; Baseline CT scan will be collected to determine the body composition. ; Images will be anonymized and centrally analyzed to assess radiomic features that will be correlated with CNS toxicity. ; Baseline body CT scan and brain MRI and first tumor assessment will be collected to determine body composition and to compare radiomic characteristics in patients who developed CNS AEs with those who did not.
• Data sources (types):
  Electronic healthcare records (EHR)

  Non-interventional study

  Other
• Data sources (types), other:
  Patient Reported Outcome (PRO)

Use of a Common Data Model (CDM)

• CDM mapping:
  No

Data quality specifications

• Check conformance:
  No
• Check completeness:
  No
• Check stability:
  No
• Check logical consistency:
  Unknown

Data characterisation

• Data characterisation conducted:
  No