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

Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• To evaluate the frequency of patients with oncogene addiction in a consecutive series of patients afferent to the CRO with NSCLC. [Срок оценки: up to 15 years]

Вторичные конечные точки (7)

• Frequency of mutations according to tumor histotype (squamous and nonsquamous) [Срок оценки: up to 15 years]
• Evaluate trend of mutations over time [Срок оценки: up to 15 years]
• Compare PFS in new patients with and without oncogene addiction [Срок оценки: up to 15 years]
• Compare OS in new patients with and without oncogene addiction [Срок оценки: up to 15 years]
• Assess OS in different mutation types, stratifying by histotype [Срок оценки: up to 15 years]
• Assess PFS in different mutation types, stratifying by histotype [Срок оценки: up to 15 years]
• Assess the frequency of different types of molecular alterations and possible new target alterations [Срок оценки: up to 15 years]

Критерии участия

Критерии включения

• First visit or first admission to CRO occurred in the period from September 2023 to September 2028
• Diagnosis of NSCLC any stage

Критерии исключения

\- Diagnosis of tumor not of certain lung origin (uncertain origin)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 1 центр

• Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS — Aviano

Идентификаторы

NCT: NCT06180005 · CRO-2023-38

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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