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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Non Small Cell Lung Cancer

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 700

Contacts and Locations

• Study Contact: Name: Alessandro Del Conte, MD; Phone Number: 0434 399464; Email: alessandro.delconte@cro.it

Study Locations

• Italy
  • Pordenone
    • Aviano, Pordenone, Italy, 33081
      • Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS
      • Contact: Alessandro Del Conte, MD; Phone Number: 0434 399464; Email: alessandro.delconte@cro.it
      • Principal Investigator: Alessandro Del Conte, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Evaluate trend of mutations over time	Frequency of patient carrying one target mutation in each study year	up to 15 years
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centro di Riferimento Oncologico - Aviano
• Investigators: Principal Investigator: Alessandro Del Conte, MD, Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS; Study Director: Alessandra Bearz, MD, Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS

Study record dates

Study Major Dates

• Study Start (Estimated): January 2, 2024
• Primary Completion (Estimated): January 2, 2039
• Study Completion (Estimated): December 30, 2039

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: December 21, 2023
• First Posted (Actual): December 22, 2023

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: CRO-2023-38

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No