Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06317558

Real-world Clinical Outcomes of NSCLC Patients Receiving Neoadjuvant Immunotherapy

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

NSCLC

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shugeng Gao

Beijing, Beijing Municipality, 100020, China

Location status: Recruiting

Location contact

Shugeng Gao, MD

CONTACT

[email protected]

010-87788177

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

neoadjuvant immunotherapy

Drug

Immune checkpoint inhibitors are used as neoadjuvant settings for NSCLC patients.

Other names: Immune checkpoint inhibitors

Other drugs for neoadjuvant treatment

Drug

Drugs other than immune checkpoint inhibitors are being used as a new adjuvant setting for patients with NSCLC.

Other names: Other drugs

Primary outcomes

  1. Pathological Complete Response (pCR)

    Time frame: Within 15 days after surgery

    defined as 0% of viable tumor cells in primary tumor and lymph nodes

  2. 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.

    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).

Secondary outcomes

  1. Overall survival (OS)

    Time frame: From date of surgery until date of death due to any cause, up to approximately 10 years.

    OS is defined as the time from surgery time until death from any cause.

  2. 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.

    EFS was defined as time from study inclusion (first dose date) to disease progression, death, or discontinuation of treatment.

  3. Major Pathological Response (MPR)

    Time frame: Within 15 days after surgery

    defined as ≤10% of viable tumor cells

  4. Relapse Patterns

    Time frame: Within 10 years after surgery

    Relapse was defined as disease recurrence at any site.

Study contacts

Contact information is provided by the study sponsor or research team.

Shugeng Gao, MD

CONTACT

[email protected]

8610-87788177

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

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

Acronym: NeoIM-Lung

Important dates

Study start
2024
Primary completion
2026
Study completion
2034
First posted
Mar 19, 2024
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.