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NCT Number: NCT06180005

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.

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS

Aviano, Pordenone, 33081, Italy

Location status: Recruiting

Location contact

Alessandro Del Conte, MD

CONTACT

[email protected]

0434 399464

Alessandro Del Conte, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. To evaluate the frequency of patients with oncogene addiction in a consecutive series of patients afferent to the CRO with NSCLC.

    Time frame: up to 15 years

    Frequency of patients carriers of one of the mutations among EGFR, ALK, RET, KRAS, BRAF, Her2, ROS1, MET

Secondary outcomes

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

    Time frame: up to 15 years

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

  2. Evaluate trend of mutations over time

    Time frame: up to 15 years

    Frequency of patient carrying one target mutation in each study year

  3. Compare PFS in new patients with and without oncogene addiction

    Time frame: up to 15 years

    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

  4. Compare OS in new patients with and without oncogene addiction

    Time frame: up to 15 years

    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

  5. Assess OS in different mutation types, stratifying by histotype

    Time frame: up to 15 years

    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

  6. Assess PFS in different mutation types, stratifying by histotype

    Time frame: up to 15 years

    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

  7. Assess the frequency of different types of molecular alterations and possible new target alterations

    Time frame: up to 15 years

    Frequency of different types of targetable molecular alterations, including possible new target alterations emerging during study period

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

    Time frame: up to 15 years

    Key information to identify in the unstructured text will be defined and frequency of correct identification will be reported

Study contacts

Contact information is provided by the study sponsor or research team.

Alessandro Del Conte, MD

CONTACT

[email protected]

0434 399464

Sponsors and collaborators

Lead sponsor

Centro di Riferimento Oncologico - Aviano

Other

Registry information

Official study title

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

Acronym: INOND

Important dates

Study start
2024
Primary completion
2039
Study completion
2039
First posted
Dec 22, 2023
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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