NSCLC
Conditions
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.
Interventions
DRUGNeoadjuvant immunotherapy
Immune checkpoint inhibitors are used as neoadjuvant settings for NSCLC patients.
DRUGOther drugs for neoadjuvant treatment
Drugs other than immune checkpoint inhibitors are being used as a new adjuvant setting for patients with NSCLC.
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Histological diagnosis of non-small cell lung cancer (Stage I-IV, International Association for the Study of Lung Cancer staging eighth edition) 2. Patients who have previously undergone immune checkpoint inhibitors as the neoadjuvant treatment; 3. No previous history of malignant tumors and other malignant tumors at the same time, without any anti-tumor treatment; 4. Eastern Cooperative Oncology Group (ECOG) score 0-1, heart, lung, liver, brain and kidney function can tolerate surgery; 5. At least one measurable lesion (RECIST v1.1).
Exclusion criteria
1. Patients included in unblinded clinical trials or anti-tumor drug intervention. 2. Radiotherapy or systemic therapy were used for NSCLC patients before the surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological Complete Response (pCR) | Within 15 days after surgery | defined as 0% of viable tumor cells in primary tumor and lymph nodes |
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Major Pathological Response (MPR) | Within 15 days after surgery | defined as ≤10% of viable tumor cells |
| Relapse Patterns | Within 10 years after surgery | Relapse was defined as disease recurrence at any site. |
Countries
China
Contacts
Primary ContactShugeng Gao, MD
Outcome results
None listed