Incidence and Characterization of Drivers Oncogenes in the Population With Lung Cancer Afferents to the Cancer Institute in Aviano (IN.ON.D.)
- Conditions
- Non Small Cell Lung Cancer
- Registration Number
- NCT06180005
- Lead Sponsor
- Centro di Riferimento Oncologico - Aviano
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 700
- First visit or first admission to CRO occurred in the period from September 2023 to September 2028
- Diagnosis of NSCLC any stage
- Diagnosis of tumor not of certain lung origin (uncertain origin)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the frequency of patients with oncogene addiction in a consecutive series of patients afferent to the CRO with NSCLC. up to 15 years Frequency of patients carriers of one of the mutations among EGFR, ALK, RET, KRAS, BRAF, Her2, ROS1, MET
- Secondary Outcome Measures
Name Time Method Compare PFS in new patients with and without oncogene addiction 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
Assess OS in different mutation types, stratifying by histotype 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
Assess PFS in different mutation types, stratifying by histotype 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
Assess the frequency of different types of molecular alterations and possible new target alterations up to 15 years Frequency of different types of targetable molecular alterations, including possible new target alterations emerging during study period
Frequency of mutations according to tumor histotype (squamous and nonsquamous) up to 15 years Frequency of selected mutations according to tumor histotype (squamous and nonsquamous)
Evaluate trend of mutations over time up to 15 years Frequency of patient carrying one target mutation in each study year
Compare OS in new patients with and without oncogene addiction 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
Trial Locations
- Locations (1)
Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS
🇮🇹Aviano, Pordenone, Italy