Efficacy of Neoadjuvant Immunotherapy in Patients With Lung Cancer (NeoIP-Lung)

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Immunotherapy; Lung Cancer, Non-Small Cell

Treatments: Drug: Anti-Tumor Drugs; Radiation: radiotherapy; Procedure: Pneumonectomy; Procedure: lobectomy

Study type: Observational

Funder types: Other

Identifiers

NCT07166003

2025040620521402

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 2 patient groups

Surgery

Description:

Patients will undergo surgery after neoadjuvant immunotherapy.

Treatment:

Procedure: lobectomy

Procedure: Pneumonectomy

Non-surgery

Description:

Patients will receive non-surgical treatment after neoadjuvant treatment.

Treatment:

Radiation: radiotherapy

Drug: Anti-Tumor Drugs