Real-world Clinical Outcomes of NSCLC Patients Receiving Neoadjuvant Immunotherapy
- Conditions
- NSCLC
- Interventions
- Drug: Neoadjuvant immunotherapyDrug: Other drugs for neoadjuvant treatment
- Registration Number
- NCT06317558
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 4000
- 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).
- Patients included in unblinded clinical trials or anti-tumor drug intervention.
- Radiotherapy or systemic therapy were used for NSCLC patients before the surgery.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Neoadjuvant immunotherapy Neoadjuvant immunotherapy Immune checkpoint inhibitors are used for neoadjuvant treatment in this cohort. Other neoadjuvant treatment Other drugs for neoadjuvant treatment Other drugs other than Immune checkpoint inhibitors are used for neoadjuvant treatment in this cohort.
- Primary Outcome Measures
Name Time Method Disease-free survival (DFS) 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. Defined as the time from the date of randomization until the date of disease recurrence or death (by any cause in the absence of recurrence).
Pathological Complete Response (pCR) Within 15 days after surgery defined as 0% of viable tumor cells in primary tumor and lymph nodes
- Secondary Outcome Measures
Name Time Method Event-free survival (EFS) EFS was defined as time from first dose date to disease progression, death, or discontinuation of treatment, up to approximately 10 years. EFS was defined as time from study inclusion (first dose date) to disease progression, death, or discontinuation of treatment.
Relapse Patterns Within 10 years after surgery Relapse was defined as disease recurrence at any site.
Overall survival (OS) From date of surgery until date of death due to any cause, up to approximately 10 years. OS is defined as the time from surgery time until death from any cause.
Major Pathological Response (MPR) Within 15 days after surgery defined as ≤10% of viable tumor cells
Trial Locations
- Locations (1)
Shugeng Gao
🇨🇳Beijing, Beijing, China