Actively Recruiting
Downstaging and RATS After Neo-Chemo-IO: Impact on Surgical Outcomes in NSCLC
Led by Shanghai Chest Hospital · Updated on 2026-04-14
200
Participants Needed
10
Research Sites
56 weeks
Total Duration
On this page
Sponsors
S
Shanghai Chest Hospital
Lead Sponsor
T
The Affiliated Hospital of Qingdao University
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this observational study is to learn whether tumor and nodal downstaging after neoadjuvant chemo-immunotherapy is associated with better surgical outcomes in patients with clinical stage IIB-III non-small cell lung cancer (NSCLC) undergoing robotic-assisted thoracic surgery. The main question it aims to answer is: Is downstaging after neoadjuvant chemo-immunotherapy associated with better surgical outcomes in patients with stage IIB-III NSCLC undergoing robotic-assisted surgery? Participants with resectable or potentially resectable stage IIB-III NSCLC who receive neoadjuvant chemo-immunotherapy as part of their routine clinical care and then undergo curative-intent robotic-assisted surgery will be prospectively enrolled from international centers. Clinical, operative, pathological, and postoperative outcome data will be collected, including R0 resection, the extent of resection, conversion to open surgery, postoperative complications, length of stay, readmission, and mortality.
CONDITIONS
Official Title
Downstaging and RATS After Neo-Chemo-IO: Impact on Surgical Outcomes in NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed non-small cell lung cancer
- Clinical stage IIB-III (AJCC 9th edition), M0, resectable or potentially resectable as determined by multidisciplinary tumor discussion
- Planned neoadjuvant chemo-immunotherapy with PD-1/PD-L1 inhibitor plus platinum doublet chemotherapy; neoadjuvant radiation therapy allowed
- Received at least 1 cycle of chemo-immunotherapy (target 2-4 cycles)
- Baseline chest CT with or without PET-CT within 6 weeks before starting neoadjuvant therapy
- Restaging chest CT with or without PET-CT performed 2-6 weeks after last neoadjuvant dose
- Curative-intent resection planned, with surgery performed 2-10 weeks after last neoadjuvant dose
- Systematic nodal dissection performed during surgery
- ECOG performance status between 0 and 2
- Willing and able to complete 90-day postoperative follow-up
- Ability to provide informed consent
You will not qualify if you...
- Presence of metastatic disease (M1) at baseline or restaging
- Neoadjuvant regimen without immunotherapy component (unless enrolled in prespecified comparator cohort)
- Prior systemic therapy or thoracic radiotherapy for current lung cancer before starting neoadjuvant chemo-immunotherapy
- Planned neoadjuvant chemoradiation without immunotherapy
- Definitive decision against surgery before starting neoadjuvant therapy
- Active autoimmune disease requiring systemic immunosuppression within past 2 years
- Prior organ transplant
- History of grade 2 or higher pneumonitis or interstitial lung disease
- Uncontrolled infection
- Pregnancy or breastfeeding
- Any condition that prevents curative-intent surgery as determined by multidisciplinary tumor discussion
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
2
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
Actively Recruiting
3
Shenzhen People's Hospital
Shenzhen, Guangdong, China, 518020
Actively Recruiting
4
Jiangsu Cancer Institute & Hospital
Nanjing, Jiangsu, China, 210009
Actively Recruiting
5
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266000
Actively Recruiting
6
Tianjin Medical University Cancer Institute & Hospital
Tianjing, Tianjing, China, 300060
Actively Recruiting
7
Shanghai Chest Hospital, Shanghai Jiao Tong University Medicine of School
Shanghai, China, 200030
Actively Recruiting
8
Hôpital Saint Joseph Marseille
Marseille, France, 13001
Actively Recruiting
9
University Hospital, Rouen
Rouen, France, 76000
Actively Recruiting
10
Azienda Ospedaliera di Cosenza
Cosenza, Italy, 87100
Actively Recruiting
Research Team
Z
Zhigang Li, MD, PhD
CONTACT
L
Lin Huang, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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