Actively Recruiting
Safety, Efficacy, and Survival Outcomes of Neoadjuvant/Induction Immunotherapy in Surgical and Radiotherapeutic Management of Non-Small Cell Lung Cancer: A Multicenter Real-World Study
Led by Peking University Cancer Hospital & Institute · Updated on 2025-04-16
500
Participants Needed
4
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, effectiveness, and survival results of neoadjuvant or induction immunotherapy in patients with non-small cell lung cancer (NSCLC). This study focuses on real-world outcomes across multiple centers, including patients undergoing surgery, definitive radiotherapy, or non-surgical treatments. It aims to fill gaps left by previous trials by including a diverse patient group, covering treatment from the initial immunotherapy phase through surgery and follow-up, to better support clinical decisions for both operable and inoperable cases. The study observes patients who have received neoadjuvant immune checkpoint inhibitors, such as PD-1/PD-L1 blockers, either alone or combined with chemotherapy. All treatments, including surgery and radiotherapy, follow routine care as determined by the patients' doctors. This retrospective observational design collects data on various treatment paths to assess outcomes in normal clinical practice. Participants' medical records are reviewed to analyze technical surgical difficulty, disease-free survival, postoperative complications, treatment-related adverse events, and other key clinical outcomes. The study includes follow-up periods of up to five years to monitor progression-free and overall survival. This comprehensive data collection helps provide real-world evidence on the benefits and risks of neoadjuvant immunotherapy in NSCLC management.
CONDITIONS
Brief Title
Safety, Efficacy, and Survival Outcomes of Neoadjuvant/Induction Immunotherapy in Surgical and Radiotherapeutic Management of Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed non-small cell lung cancer (NSCLC), regardless of EGFR or ALK mutations
- Clinical stage IA to IIIC according to AJCC 8th Edition before neoadjuvant treatment
- Received at least one cycle of neoadjuvant immunotherapy, with or without chemotherapy
- Assessed as resectable or potentially resectable by surgical experts before treatment
You will not qualify if you...
- Confirmed stage M1 disease
- History of previous lung cancer or other metastatic cancers
- Participation in other randomized controlled trials involving neoadjuvant treatment
- Significant missing clinical data
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 - Varies depending on treatment course
Participants receive neoadjuvant immunotherapy, with or without chemotherapy, as part of routine clinical care before surgery or radiotherapy.
Visits occur as part of routine care during neoadjuvant therapy
Duration - Day of surgery and up to 30 days post-surgery
Participants undergo radical surgery with assessment of perioperative safety and surgical outcomes.
1 surgery day visit and approximately 6 post-operative visits
Duration - Up to 5 years after surgery
Participants are monitored for disease-free survival and treatment-related adverse events up to 5 years after surgery.
Regular follow-up visits over 5 years
Trial Site Locations
Total: 4 locations
1
Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
2
Peking University Third Hospital
Beijing, Beijing Municipality, China
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3
Inner Mongolia Hospital of Peking University Cancer Hospital
Hohhot, Inner Mongolia, China
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4
The Third Affliated Hospital of Kunming Medical University
Kunming, Yunnan, China
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Research Team
N
Nan Wu, 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
0
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