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

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

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.

Study Overview

• Status: Recruiting
• Conditions: NSCLC
• Intervention / Treatment: Drug: Neoadjuvant immunotherapy; Drug: Other drugs for neoadjuvant treatment

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.

• Study Type: Observational
• Enrollment (Estimated): 4000

Contacts and Locations

• Study Contact: Name: Shugeng Gao, MD; Phone Number: 8610-87788177; Email: gaoshugeng@cicams.ac.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100020
      • Recruiting
      • Shugeng Gao
      • Contact: Shugeng Gao, MD; Phone Number: 010-87788177; Email: gaoshugeng@cicams.ac.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

NSCLC patients receiving neoadjuvant immunotherapy.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Neoadjuvant immunotherapy; Immune checkpoint inhibitors are used for neoadjuvant treatment in this cohort.	Drug: Neoadjuvant immunotherapy; Immune checkpoint inhibitors are used as neoadjuvant settings for NSCLC patients.; Other Names: Immune checkpoint inhibitors
Other neoadjuvant treatment; Other drugs other than Immune checkpoint inhibitors are used for neoadjuvant treatment in this cohort.	Drug: Other drugs for neoadjuvant treatment; Drugs other than immune checkpoint inhibitors are being used as a new adjuvant setting for patients with NSCLC.; Other Names: Other drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological Complete Response (pCR)	defined as 0% of viable tumor cells in primary tumor and lymph nodes	Within 15 days after surgery
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 about 10 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Pathological Response (MPR)	defined as ≤10% of viable tumor cells	Within 15 days after surgery
Relapse Patterns	Relapse was defined as disease recurrence at any site.	Within 10 years after surgery
Overall survival (OS)	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.
Event-free survival (EFS)	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.

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Principal Investigator: Shugeng Gao, MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): December 31, 2034

Study Registration Dates

• First Submitted: March 12, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 19, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: June 29, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors
• Other Study ID Numbers: 22/492-3694

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No