Real-world Clinical Outcomes of NSCLC Patients Receiving Neoadjuvant Immunotherapy (NeoIM-Lung)

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: NSCLC

Treatments: Drug: Other drugs for neoadjuvant treatment; Drug: Neoadjuvant immunotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT06317558

22/492-3694

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,000 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

4,000 participants in 2 patient groups

Neoadjuvant immunotherapy

Description:

Immune checkpoint inhibitors are used for neoadjuvant treatment in this cohort.

Treatment:

Drug: Neoadjuvant immunotherapy

Other neoadjuvant treatment

Description:

Other drugs other than Immune checkpoint inhibitors are used for neoadjuvant treatment in this cohort.

Treatment:

Drug: Other drugs for neoadjuvant treatment