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Efficacy of Neoadjuvant Immunotherapy in Patients With Lung Cancer

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07166003
Acronym
NeoIP-Lung
Enrollment
500
Registered
2025-09-10
Start date
2025-04-20
Completion date
2030-04-14
Last updated
2025-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immunotherapy, Lung Cancer, Non-Small Cell

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.

Interventions

PROCEDUREPneumonectomy

Patients will receive pneumonectomy after neoadjuvant treatment

PROCEDURElobectomy

Patients will receive lobectomy after neoadjuvant immunotherapy.

RADIATIONradiotherapy

Patients will receive radiotherapy after neoadjuvant immunotherapy.

Patients will receive anti-tumor drugs.

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 79 Years

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.

Design outcomes

Primary

MeasureTime frame
Event-free survivalEvent-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

MeasureTime frameDescription
Overall survivalFrom date of neoadjuvant treatment until date of death due to any cause, up to approximately 10 years.
Perioperative Complication rateWithin 6 months after neoadjuvant treatment.Complications after the neoadjuvant treatment.

Countries

China

Contacts

Primary ContactShugeng Gao, MD
gaoshugeng@cicams.ac.cn8610-87788177

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026