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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06317558
Other study ID # 22/492-3694
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2024
Est. completion date December 31, 2027

Study information

Verified date March 2024
Source Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this observational study is to evaluate the efficacy and long-term clinical outcomes of different neoadjuvant immunotherapies in 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 4000
Est. completion date December 31, 2027
Est. primary completion date March 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: 1. Histological diagnosis of non-small cell lung cancer (Stage I-IV, IASLC/UICC 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. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
China Shugeng Gao Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pathological Complete Response (pCR) defined as 0% of viable tumor cells in primary tumor and lymph nodes Within 15 days after surgery
Primary Disease-free survival(DFS) 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). 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 approximately 10 years.
Secondary OS (overall survival) OS is defined as the time from surgery time until death from any cause. From date of surgery until date of death due to any cause, up to approximately 10 years.
Secondary EFS (event-free survival) EFS was defined as time from study inclusion (first dose date) to disease progression, death, or discontinuation of treatment. EFS was defined as time from first dose date to disease progression, death, or discontinuation of treatment, up to approximately 10 years.
Secondary Major Pathological Response (MPR) defined as =10% of viable tumor cells Within 15 days after surgery
Secondary Relapse Patterns Relapse was defined as disease recurrence at any site. Within 10 years after surgery
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