Incidence and Characterization of Drivers Oncogenes in the Population With Lung Cancer Afferents to the Cancer Institute in Aviano (IN.ON.D.)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorCentro di Riferimento Oncologico - Aviano

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
up to 15 years

Secondary outcomes

1

Frequency of mutations according to tumor histotype (squamous and nonsquamous)

Frequency of selected mutations according to tumor histotype (squamous and nonsquamous)

Time frame
up to 15 years
2

Evaluate trend of mutations over time

Frequency of patient carrying one target mutation in each study year

Time frame
up to 15 years
3

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

Time frame
up to 15 years
4

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

Time frame
up to 15 years

Other outcomes

1

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

Time frame
up to 15 years

Sponsors and contacts

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