Actively Recruiting
Effects of Neoadjuvant Immunotherapy on Patients With Lung Cancer: a Prospective, Observational Study
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2025-09-10
500
Participants Needed
1
Research Sites
166 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the long-term effects of neoadjuvant immunotherapy in patients with non-small cell lung cancer. This observational study aims to determine if pneumonectomy offers more benefits than lobectomy, and whether surgery provides greater advantages compared to non-surgical treatments such as radiotherapy after neoadjuvant immunotherapy. The goal is to improve clinical decision-making and patient care by analyzing these treatment approaches. Participants will have received neoadjuvant immunotherapy before entering the study. Some will undergo surgery, either pneumonectomy or lobectomy, while others will receive non-surgical treatments like radiotherapy or anti-tumor drugs after their initial immunotherapy. The study will observe and compare these treatment paths without assigning interventions. During the study, participants’ health and treatment outcomes will be monitored, including event-free survival, defined as time from neoadjuvant treatment to metastasis or death, tracked for up to about 10 years. Other measures include overall survival and perioperative complication rates within six months after neoadjuvant therapy. The study involves collecting clinical data, imaging, and monitoring participants over the long term to understand the effects of these treatments.
CONDITIONS
Brief Title
Efficacy of Neoadjuvant Immunotherapy in Patients With Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of at least two cycles as per treatment plan
Participants receive neoadjuvant immunotherapy treatment before further procedures.
Visits as required for neoadjuvant immunotherapy
Duration - Up to 6 months following neoadjuvant treatment
Participants undergo either surgery (pneumonectomy or lobectomy) or non-surgical treatment such as radiotherapy following neoadjuvant immunotherapy.
Visits depending on treatment type and recovery
Duration - Up to approximately 10 years
Participants are monitored for long-term outcomes including survival and recurrence after treatment completion.
Periodic visits as scheduled by the study for outcome assessments
Trial Site Locations
Total: 1 location
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Actively Recruiting
Research Team
S
Shugeng Gao, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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