Non Small Cell Lung Cancer
Conditions
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.
Interventions
None listed
Sponsors
Centro di Riferimento Oncologico - Aviano
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | up to 15 years | Key information to identify in the unstructured text will be defined and frequency of correct identification will be reported |
Countries
Italy
Contacts
Primary ContactAlessandro Del Conte, MD
Outcome results
None listed