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

Non Small Cell Lung Cancer Clinical Trial

— INOND  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06180005
• Other study ID #: CRO-2023-38
• Status: Not yet recruiting
• Start date: January 2, 2024
• Est. completion date: December 30, 2039

Study information

• Verified date: December 2023
• Source: Centro di Riferimento Oncologico - Aviano
• Contact: Alessandro Del Conte, MD
• Phone: 0434 399464
• Email: alessandro.delconte[@]cro.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 700
• Est. completion date: December 30, 2039
• Est. primary completion date: January 2, 2039
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• First visit or first admission to CRO occurred in the period from September 2023 to September 2028

• Diagnosis of NSCLC any stage

Exclusion Criteria:

• Diagnosis of tumor not of certain lung origin (uncertain origin)

Related Conditions & MeSH terms

• Lung Neoplasms
• Non Small Cell Lung Cancer

Locations

Country	Name	City	State
Italy	Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS	Aviano	Pordenone

Sponsors (1)

Lead Sponsor	Collaborator
Centro di Riferimento Oncologico - Aviano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	up to 15 years
Primary	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	up to 15 years
Secondary	Frequency of mutations according to tumor histotype (squamous and nonsquamous)	Frequency of selected mutations according to tumor histotype (squamous and nonsquamous)	up to 15 years
Secondary	Evaluate trend of mutations over time	Frequency of patient carrying one target mutation in each study year	up to 15 years
Secondary	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	up to 15 years
Secondary	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	up to 15 years
Secondary	Assess OS in different mutation types, stratifying by histotype	Describe OS probability in different mutation types, stratifying by histotype. OS will be defined as time between enrollment in the study (first visit) and death from any cause or the end of the study	up to 15 years
Secondary	Assess PFS in different mutation types, stratifying by histotype	Describe PFS probability in different mutation types, stratifying by histotype. 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	up to 15 years
Secondary	Assess the frequency of different types of molecular alterations and possible new target alterations	Frequency of different types of targetable molecular alterations, including possible new target alterations emerging during study period	up to 15 years