Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Phase
Observational
Started
2024-03-01
Last updated
2024-07-03
Condition(s) studied
NSCLC
Investigational drug(s) / intervention(s)
Neoadjuvant immunotherapyOther drugs for neoadjuvant treatment
Neoadjuvant immunotherapy: Immune checkpoint inhibitors are used as neoadjuvant settings for NSCLC patients.
Other drugs for neoadjuvant treatment: Drugs other than immune checkpoint inhibitors are being used as a new adjuvant setting for patients with NSCLC.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
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.
Primary outcome measure(s)
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).
Trial sites (1)
Facility
City
Region
Status
Shugeng Gao
Beijing
Beijing Municipality
Recruiting
More Cancer Institute and Hospital, Chinese Academy of Medical Sciences trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.