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/35190177Actively Recruiting
All Genders
ID07528066
The Impact of Downstaging on Robotic Surgical Outcomes After Neoadjuvant Chemo-Immunotherapy in Non-Small Cell Lung Cancer
Led by Shanghai Chest Hospital · Updated on 2026-04-14
200
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 investigating whether tumor and lymph node downstaging after neoadjuvant chemo-immunotherapy is linked to better surgical outcomes in patients with clinical stage IIB-III non-small cell lung cancer (NSCLC). This observational study focuses on patients undergoing robotic-assisted thoracic surgery and aims to understand if this downstaging improves surgery success and recovery. Participants receive neoadjuvant chemo-immunotherapy, which includes PD-1/PD-L1 inhibitors combined with platinum-based chemotherapy, sometimes with added radiation therapy before surgery. After treatment, they undergo robotic-assisted lung surgery with systematic lymph node removal. The study collects data on surgical completeness, extent of resection, any conversion to open surgery, complications, hospital stay length, readmission, and mortality. During the study, researchers gather clinical, surgical, pathological, and postoperative outcome information. Participants have baseline and restaging chest scans before surgery, and follow-up extends to 90 days after surgery to monitor complications and recovery. The main outcome measured is complete tumor removal, with additional monitoring of hospital stay duration, postoperative problems, readmission rates, and mortality within 30 and 90 days.
CONDITIONS
Brief Title
Downstaging and RATS After Neo-Chemo-IO: Impact on Surgical Outcomes in NSCLC
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed non-small cell lung cancer (NSCLC)
- Clinical stage IIB-III, M0, judged resectable or potentially resectable by multidisciplinary tumor discussion
- Planned neoadjuvant chemo-immunotherapy including PD-1/PD-L1 inhibitor plus platinum doublet chemotherapy; neoadjuvant radiation therapy allowed
- Received at least 1 cycle of chemo-immunotherapy (intended 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 2-6 weeks after last neoadjuvant dose
- Planned curative-intent resection surgery performed 2-10 weeks after last neoadjuvant dose
- Systematic nodal dissection performed
- ECOG performance status 0 to 2
- Complete 90-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 the neoadjuvant regimen unless in a 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 needing systemic immunosuppression within 2 years, prior organ transplant, or history of grade 2 or higher pneumonitis/interstitial lung disease
- Uncontrolled infection, pregnancy or lactation, or any condition preventing curative-intent surgery per multidisciplinary tumor discussion
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)
Treatment
Duration - Neoadjuvant chemo-immunotherapy for 2 to 4 cycles followed by surgery 2 to 10 weeks after last dose
Participants receive neoadjuvant chemo-immunotherapy followed by planned robotic-assisted thoracoscopic surgery to remove lung cancer.
1 to 2 visits for neoadjuvant therapy and 1 surgery visit
Post-operative Follow-up
Duration - Up to 3 months after surgery
Participants are monitored for recovery and potential complications after surgery.
Approximately 3 follow-up visits over 3 months
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
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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
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Luis J Herrera, Lana Y Schumacher, Matthew G Hartwig...
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Beatrice Trabalza Marinucci, Massimiliano Mancini, Alessandra Siciliani...
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Wenyi Liu, Jinming Tang, Xu Li...
https://pubmed.ncbi.nlm.nih.gov/40917729Real-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/40923935