Real-world Clinical Outcomes of NSCLC Patients Receiving Neoadjuvant Immunotherapy

Официальное название

Real-world Clinical Outcomes of Neoadjuvant Immunotherapy in NSCLC Patients: A Retrospective, Multi-center, Cohort Study (NeoIM-Lung)

Обзор

The goal of this observational study is to evaluate the efficacy and long-term clinical outcomes of different neoadjuvant immunotherapies in non-small cell lung cancer (NSCLC) patients using the real-world data. The main questions it aims to answer are: * What the best setting for immune checkpoint inhibitors as the neoadjuvant treatment? * How to determine the subgroups of patients benefit from neoadjuvant immunotherapy? Participants will receive neoadjuvant immunotherapy the study will analyze the real-world data.

Подробное описание

The objective of this observational study is to assess the effectiveness and long-term clinical outcomes of various neoadjuvant immunotherapies in patients with non-small cell lung cancer (NSCLC), using the real-world data. The primary inquiries it seeks to address include:

* What is the optimal strategy for utilizing immune checkpoint inhibitors as neoadjuvant therapy? * How can we identify specific patient subgroups that derive the greatest benefit from neoadjuvant immunotherapy? Participants will undergo neoadjuvant immunotherapy, and the study will meticulously analyze real-world data to provide insights into these pivotal questions, contributing to the refinement of treatment strategies and patient care in NSCLC management.

Вмешательства

• Препарат Neoadjuvant immunotherapy
  Immune checkpoint inhibitors are used as neoadjuvant settings for NSCLC patients.
• Препарат Other drugs for neoadjuvant treatment
  Drugs other than immune checkpoint inhibitors are being used as a new adjuvant setting for patients with NSCLC.

Первичные конечные точки

• Pathological Complete Response (pCR) [Срок оценки: Within 15 days after surgery]
• Disease-free survival (DFS) [Срок оценки: DFS was defined as the time from surgery to the date of disease recurrence or death (by any cause in the absence of recurrence), up to about 10 years.]

Вторичные конечные точки (4)

• Overall survival (OS) [Срок оценки: From date of surgery until date of death due to any cause, up to approximately 10 years.]
• Event-free survival (EFS) [Срок оценки: EFS was defined as time from first dose date to disease progression, death, or discontinuation of treatment, up to approximately 10 years.]
• Major Pathological Response (MPR) [Срок оценки: Within 15 days after surgery]
• Relapse Patterns [Срок оценки: Within 10 years after surgery]

Критерии участия

Критерии включения

• Histological diagnosis of non-small cell lung cancer (Stage I-IV, International Association for the Study of Lung Cancer staging eighth edition)
• Patients who have previously undergone immune checkpoint inhibitors as the neoadjuvant treatment;
• No previous history of malignant tumors and other malignant tumors at the same time, without any anti-tumor treatment;
• Eastern Cooperative Oncology Group (ECOG) score 0-1, heart, lung, liver, brain and kidney function can tolerate surgery;
• At least one measurable lesion (RECIST v1.1).

Критерии исключения

• Patients included in unblinded clinical trials or anti-tumor drug intervention.
• Radiotherapy or systemic therapy were used for NSCLC patients before the surgery.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Shugeng Gao — Пекин

Идентификаторы

NCT: NCT06317558 · 22/492-3694

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗