Efficacy of Neoadjuvant Immunotherapy in Patients With Lung Cancer

NCT ID: NCT07166003

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-20
• Study Completion Date: 2030-04-14

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.

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.

Conditions

Lung Cancer, Non-Small Cell; Immunotherapy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Surgery

Patients will undergo surgery after neoadjuvant immunotherapy.

Pneumonectomy

Intervention Type: PROCEDURE

Patients will receive pneumonectomy after neoadjuvant treatment

lobectomy

Intervention Type: PROCEDURE

Patients will receive lobectomy after neoadjuvant immunotherapy.

Non-surgery

Patients will receive non-surgical treatment after neoadjuvant treatment.

radiotherapy

Intervention Type: RADIATION

Patients will receive radiotherapy after neoadjuvant immunotherapy.

Anti-Tumor Drugs

Intervention Type: DRUG

Patients will receive anti-tumor drugs.

Interventions

Pneumonectomy

Patients will receive pneumonectomy after neoadjuvant treatment

Intervention Type: PROCEDURE

lobectomy

Patients will receive lobectomy after neoadjuvant immunotherapy.

Intervention Type: PROCEDURE

radiotherapy

Patients will receive radiotherapy after neoadjuvant immunotherapy.

Intervention Type: RADIATION

Anti-Tumor Drugs

Patients will receive anti-tumor drugs.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Aged between 18 and 79 years;

2. Received at least two cycles of neoadjuvant immunotherapy;

3. ECOG performance status score of 0;

4. Complete clinical information including imaging data available.

Exclusion Criteria

1. Diagnosed with or suspected active autoimmune diseases;

2. Presence of EGFR/ALK sensitive mutations;

3. Pregnant or breastfeeding women;

4. Previous anti-tumor therapies including chemotherapy or radiotherapy;

5. History of organ transplantation or hematopoietic stem cell transplantation;

6. Interstitial pneumonia, pulmonary fibrosis, or severe emphysema;

7. Uncontrolled diabetes mellitus;

8. Uncontrolled hypertension.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Shugeng Gao, MD

Role: CONTACT

gaoshugeng@cicams.ac.cn

8610-87788177

Facility Contacts

Shugeng Gao, MD

Role: primary

guowei@cicams.ac.cn

8610-87788177

Other Identifiers

2025040620521402

Identifier Type: -

Identifier Source: org_study_id