Menu
Recruiting NCT07166003

Efficacy of Neoadjuvant Immunotherapy in Patients With Lung Cancer

Observational Lung Cancer, Non-Small Cell Immunotherapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pneumonectomy, lobectomy, radiotherapy, Anti-Tumor Drugs.
Who it may be relevant to
Registry conditions: Lung Cancer, Non-Small Cell, Immunotherapy. Basic parameters: 18 years — 79 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effects of Neoadjuvant Immunotherapy on Patients With Lung Cancer: a Prospective, Observational Study

Overview

The goal of this observational study is to learn about the long-term effects of neoadjuvant immunotherapy in patients with lung cancer. The main questions it aims to answer are: * Does pneumonectomy bring more benefits for pateints than lobectomy? * Does surgery bring more benefits for patients than non-surgery modalities (such as radiotherapy) after neoadjuvnat immunotherapy? Participants will receive neoadjuvant treatment and the study will analyze the data.

Detailed description

This observational study aims to comprehensively evaluate the effectiveness and long-term clinical outcomes of neoadjuvant treatment in patients with lung cancer. Central to this investigation are two key questions: ·Does pneumonectomy bring more benefits for pateints than lobectomy?

* Does surgery bring more benefits for patients than non-surgery modalities (such as radiotherapy) after neoadjuvnat immunotherapy? Participants will receive neoadjuvant treatment, and through rigorous analysis of data, this study endeavors to provide nuanced insights into these fundamental queries, fostering advancements in clinical decision-making and patient management strategies.

Interventions

  • Procedure Pneumonectomy
    Patients will receive pneumonectomy after neoadjuvant treatment
  • Procedure lobectomy
    Patients will receive lobectomy after neoadjuvant immunotherapy.
  • Radiation radiotherapy
    Patients will receive radiotherapy after neoadjuvant immunotherapy.
  • Drug Anti-Tumor Drugs
    Patients will receive anti-tumor drugs.

Primary outcome measures

  • Event-free survival [Time frame: Event-free survival was defined as the time from neoadjuvant treatment to metastasis or death by any cause in the absence of metastasis, up to approximately 10 years.]
Secondary outcome measures (2)
  • Overall survival [Time frame: From date of neoadjuvant treatment until date of death due to any cause, up to approximately 10 years.]
  • Perioperative Complication rate [Time frame: Within 6 months after neoadjuvant treatment.]

Eligibility criteria

Inclusion criteria

  • Aged between 18 and 79 years;
  • Received at least two cycles of neoadjuvant immunotherapy;
  • ECOG performance status score of 0;
  • Complete clinical information including imaging data available.

Exclusion criteria

  • Diagnosed with or suspected active autoimmune diseases;
  • Presence of EGFR/ALK sensitive mutations;
  • Pregnant or breastfeeding women;
  • Previous anti-tumor therapies including chemotherapy or radiotherapy;
  • History of organ transplantation or hematopoietic stem cell transplantation;
  • Interstitial pneumonia, pulmonary fibrosis, or severe emphysema;
  • Uncontrolled diabetes mellitus;
  • Uncontrolled hypertension.

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

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Cancer Hospital Chinese Academy of Medical Sciences — Beijing

Identifiers

NCT: NCT07166003 · 2025040620521402

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗