About this trial
According to an analysis by Memorial Sloan Kettering Cancer Center patients who receive a target therapy having an oncogenic driver mutation live longer than those who do not receive it. In addition to that, therapies guided by analysis on mutations identified in ct-DNA had a favorable impact, allowing longer survival. All this suggests that the presence of a therapeutically targetable oncogene (oncogene addicted) allows target therapy, resulting in a longer life expectancy. The main objective of this study is to evaluate the frequency of patients with oncogene addiction in a consecutive series of patients with NSCLC afferent to the CRO. Oncogene addiction is defined as being carriers of one of the mutations among EGFR, ALK, RET, KRAS, BRAF, Her2, ROS1, MET or other mutations that become therapeutic targets under investigation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
First visit or first admission to CRO occurred in the period from September 2023 to September 2028
Diagnosis of NSCLC any stage
Disqualifiers
None
Trial population
The population consists of patients with NSCLC who are afferent to the CRO. All patients who give their consent to participate in the study.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
To evaluate the frequency of patients with oncogene addiction in a consecutive series of patients afferent to the CRO with NSCLC.
Frequency of patients carriers of one of the mutations among EGFR, ALK, RET, KRAS, BRAF, Her2, ROS1, MET
Secondary outcomes
Frequency of mutations according to tumor histotype (squamous and nonsquamous)
Frequency of selected mutations according to tumor histotype (squamous and nonsquamous)
Evaluate trend of mutations over time
Frequency of patient carrying one target mutation in each study year
Compare PFS in new patients with and without oncogene addiction
Difference in PFS probability between patients with and without oncogene addiction (carrier of a targetable mutation). PFS will be defined as the time between enrollment in the study (first visit) and progression or death from any cause, whichever happens first, or the end of the study
Compare OS in new patients with and without oncogene addiction
Difference in OS probability between patients with and without oncogene addiction (carrier of a targetable mutation). OS will be defined as time between enrollment in the study (first visit) and death from any cause or the end of the study
Other outcomes
Assess the feasibility of developing Neural Language Processing (NLP) algorithms for the extraction of structured data from unstructured texts and verify the reliability of the results
Key information to identify in the unstructured text will be defined and frequency of correct identification will be reported
Sponsors and contacts
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