Real-world Clinical Outcomes of NSCLC Patients Receiving Neoadjuvant Immunotherapy

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Pathological Complete Response (pCR) [Time frame: Within 15 days after surgery]
• Disease-free survival (DFS) [Time frame: 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.]

Secondary outcome measures (4)

• Overall survival (OS) [Time frame: From date of surgery until date of death due to any cause, up to approximately 10 years.]
• Event-free survival (EFS) [Time frame: EFS was defined as time from first dose date to disease progression, death, or discontinuation of treatment, up to approximately 10 years.]
• Major Pathological Response (MPR) [Time frame: Within 15 days after surgery]
• Relapse Patterns [Time frame: Within 10 years after surgery]

Eligibility criteria

Inclusion criteria

• Histological diagnosis of non-small cell lung cancer (Stage I-IV, International Association for the Study of Lung Cancer staging eighth edition)
• Patients who have previously undergone immune checkpoint inhibitors as the neoadjuvant treatment;
• No previous history of malignant tumors and other malignant tumors at the same time, without any anti-tumor treatment;
• Eastern Cooperative Oncology Group (ECOG) score 0-1, heart, lung, liver, brain and kidney function can tolerate surgery;
• At least one measurable lesion (RECIST v1.1).

Exclusion criteria

• Patients included in unblinded clinical trials or anti-tumor drug intervention.
• Radiotherapy or systemic therapy were used for NSCLC patients before the surgery.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 1 center

• Shugeng Gao — Beijing

Identifiers

NCT: NCT06317558 · 22/492-3694

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗