Determinants of successful minimally invasive surgery for resectable non-small cell lung cancer after neoadjuvant therapy.
Ngoc-Quynh Chu, Kay See Tan, Joe Dycoco...
https://pubmed.ncbi.nlm.nih.gov/39168279Actively Recruiting
All Genders
ID07541521
Robotic-Assisted Sleeve Lobectomy for Non-Small Cell Lung Cancer After Neoadjuvant Chemoimmunotherapy
Led by Shanghai Chest Hospital · Updated on 2026-04-21
100
Participants Needed
10
Research Sites
N/A
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
Researchers are studying patients with stage IIB-III non-small cell lung cancer (NSCLC) who undergo robotic-assisted sleeve lobectomy after receiving neoadjuvant chemoimmunotherapy. This observational study aims to understand the rate of unsuccessful surgeries and the factors that contribute to surgical difficulty. It also explores surgeons' subjective assessments of challenges during these operations to improve understanding of technical issues and outcomes. Participants first receive neoadjuvant chemoimmunotherapy, which includes PD-1/PD-L1 inhibitors combined with platinum-based chemotherapy, sometimes with additional thoracic radiotherapy. After this treatment, patients undergo robot-assisted thoracoscopic surgery (RATS) sleeve lobectomy with systematic lymph node removal. The study collects clinical, surgical, pathological, and short-term postoperative data, focusing on surgery success and difficulty. During the study, surgeons will evaluate intraoperative challenges such as pleural adhesions, fibrosis, lymph node fusion, and vascular inflammation. Researchers will monitor surgical success up to four weeks post-surgery and assess hospital stay length up to 30 days. Participants will undergo imaging before and after treatment, and their follow-up continues for 30 days to track outcomes and complications.
CONDITIONS
Brief Title
RATS Sleeve Lobectomy After Neo-Chemo-IO for NSCLC
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- ECOG performance status between 0 and 2
- Histologically confirmed non-small cell lung cancer (NSCLC)
- Clinical stage IIB to III, M0, deemed resectable or potentially resectable
- Planned neoadjuvant chemo-immunotherapy including PD-1/PD-L1 inhibitor and platinum doublet
- Planned curative-intent robotic-assisted thoracoscopic surgery (RATS) sleeve lobectomy with systematic nodal dissection
- Baseline and restaging imaging per protocol (CT with or without PET-CT)
- Complete 30-day postoperative follow-up
- Ability to provide informed consent
You will not qualify if you...
- Metastatic disease (M1) at baseline or on restaging
- No immunotherapy in neoadjuvant regimen (only chemotherapy)
- Prior systemic therapy or thoracic radiotherapy before starting chemoimmunotherapy
- Palliative intent or planned non-anatomic resection when sleeve/lobectomy is indicated
- Clear unresectability at restaging or multidisciplinary consensus against surgery
- Contraindication to general anesthesia or prohibitive cardiopulmonary risk
- Active autoimmune disease requiring systemic immunosuppression within 2 years
- Prior organ transplant or history of grade 2 or higher pneumonitis/ILD
- Uncontrolled infection, pregnancy, breastfeeding, or intercurrent illness compromising participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Neoadjuvant Chemoimmunotherapy
Duration - Variable duration until expected effect (partial remission, complete remission, or stable disease) is reached
Participants receive neoadjuvant chemo-immunotherapy including PD-1/PD-L1 inhibitor and platinum doublet before surgery.
Multiple visits as per treatment schedule
Surgery and Immediate Post-operative Care
Duration - Up to 4 weeks
Participants undergo robot-assisted thoracoscopic surgery (RATS) sleeve lobectomy followed by immediate post-operative care.
1 surgery visit and several post-operative visits during hospital stay
Post-operative Follow-up
Duration - 30 days
Participants complete a 30-day postoperative follow-up to monitor recovery and outcomes.
Approximately 3 to 5 follow-up visits
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
Loading map...
Research Team
Z
Zhigang Li, MD, PhD
L
Lin Huang, MD, PhD
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Surgical outcomes after neoadjuvant nivolumab or nivolumab with ipilimumab in patients with non-small cell lung cancer.
Boris Sepesi, Nicolas Zhou, William N William...
https://pubmed.ncbi.nlm.nih.gov/35190177Initial results of pulmonary resection after neoadjuvant nivolumab in patients with resectable non-small cell lung cancer.
Matthew J Bott, Stephen C Yang, Bernard J Park...
https://pubmed.ncbi.nlm.nih.gov/30718052Surgical and Pathological Results Following Neoadjuvant Nivolumab and Platinum-Based Chemotherapy for Locally Advanced Resectable NSCLC: A Multicentre Real-World Series From England.
Alessandro Brunelli, Ross Hoffman, Robin Wotton...
https://pubmed.ncbi.nlm.nih.gov/39818517Advantages of robotic-assisted thoracic surgery after neoadjuvant therapy in NSCLC: A propensity score-matched analysis.
Hong-Ji Li, Jia-Yan Ding, Qiang Nie...
https://pubmed.ncbi.nlm.nih.gov/40250266Safety and feasibility of minimally invasive lobectomy after neoadjuvant immunotherapy for non-small cell lung cancer.
Camille Mathey-Andrews, Meghan McCarthy, Alexandra L Potter...
https://pubmed.ncbi.nlm.nih.gov/36653251Real-world outcomes of neoadjuvant chemoimmunotherapy in patients with nonsmall cell lung cancer: Predictors of surgery, pathologic complete response, and event-free survival.
Alissa J Cooper, Edoardo Garbo, Andrea Arfe...
https://pubmed.ncbi.nlm.nih.gov/40923935Minimally invasive resection of non-small cell lung cancer after chemoimmunotherapy: A multicenter study in academic hospitals.
Peter J Kneuertz, Nestor Villamizar, Nasser K Altorki...
https://pubmed.ncbi.nlm.nih.gov/40716726Perioperative Nivolumab and Chemotherapy in Stage III Non-Small-Cell Lung Cancer.
Mariano Provencio, Ernest Nadal, José L González-Larriba...
https://pubmed.ncbi.nlm.nih.gov/37379158Overall Survival with Neoadjuvant Nivolumab plus Chemotherapy in Lung Cancer.
Patrick M Forde, Jonathan D Spicer, Mariano Provencio...
https://pubmed.ncbi.nlm.nih.gov/40454642