NCT06317558

Real-world Clinical Outcomes of NSCLC Patients Receiving Neoadjuvant Immunotherapy

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 4,000 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	Neoadjuvant immunotherapy	Immune checkpoint inhibitors are used as neoadjuvant settings for NSCLC patients.
DRUG	Other drugs for neoadjuvant treatment	Drugs other than immune checkpoint inhibitors are being used as a new adjuvant setting for patients with NSCLC.

Timeline

• Start date: 2024-03-01
• Primary completion: 2026-03-01
• Completion: 2034-12-31
• First posted: 2024-03-19
• Last updated: 2024-07-03

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study