Real-world Clinical Outcomes of NSCLC Patients Receiving Neoadjuvant Immunotherapy

NSCLC Clinical Trial

— NeoIM-Lung  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06317558
• Other study ID #: 22/492-3694
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC

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