Efficacy of Neoadjuvant Immunotherapy in Patients With Lung Cancer

NCT07166003 | Recruiting

• 1 other identifier: 2025040620521402
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer, Non-Small Cell; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Event-free survival

  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 Outcomes (2)

• Overall survival

  From date of neoadjuvant treatment until date of death due to any cause, up to approximately 10 years.

• Perioperative Complication rate

  Within 6 months after neoadjuvant treatment.

Study Arms (2)

Surgery

Patients will undergo surgery after neoadjuvant immunotherapy.

Procedure: Pneumonectomy; Procedure: lobectomy

Non-surgery

Patients will receive non-surgical treatment after neoadjuvant treatment.

Radiation: radiotherapy; Drug: Anti-Tumor Drugs

Interventions

Pneumonectomy PROCEDURE

Patients will receive pneumonectomy after neoadjuvant treatment

Surgery

lobectomy PROCEDURE

Patients will receive lobectomy after neoadjuvant immunotherapy.

Surgery

radiotherapy RADIATION

Patients will receive radiotherapy after neoadjuvant immunotherapy.

Non-surgery

Anti-Tumor Drugs DRUG

Patients will receive anti-tumor drugs.

Non-surgery

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with lung cancer who receive neoadjuvant immunotherapy.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pneumonectomy; Anterior Temporal Lobectomy; Radiotherapy; Antineoplastic Agents

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures; Neurosurgical Procedures; Therapeutics; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Shugeng Gao, MD

CONTACT

8610-87788177; gaoshugeng@cicams.ac.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 10, 2025
• Study Start: April 20, 2025
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): April 14, 2030
• Last Updated: September 10, 2025

Record last verified: 2025-04

Locations

CN (1)