Robotic-assisted sleeve lobectomy after neoadjuvant chemoimmunotherapy for stage IIB-III non-small cell lung cancer
Robotic-Assisted Sleeve Lobectomy for Non-Small Cell Lung Cancer After Neoadjuvant Chemoimmunotherapy
See how often robotic-assisted sleeve lobectomy after neoadjuvant chemoimmunotherapy succeeds and what makes the surgery harder for adults with stage IIB-III non-small cell lung cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | Shanghai Chest Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 10 sites (Fuzhou, Fujian and 9 other locations) |
| Trial ID | NCT07541521 on ClinicalTrials.gov |
What this trial studies
This multicenter prospective observational study enrolls adults with clinical stage IIB-III, M0 NSCLC who receive planned neoadjuvant chemoimmunotherapy followed by curative-intent robotic-assisted sleeve lobectomy. Investigators will collect clinical, imaging, intraoperative, pathological, and 30-day postoperative data and ask operating surgeons to rate intraoperative difficulty across multiple dimensions. Unsuccessful surgery is predefined as conversion to thoracotomy, non‑R0 resection, or major postoperative complications, and the study will measure the rate of these outcomes and analyze factors associated with them. The aim is to describe perioperative risk, technical challenges, and short-term outcomes to inform surgical planning and patient selection.
Who should consider this trial
Good fit: Adults (≥18 years) with histologically confirmed resectable clinical stage IIB-III NSCLC, ECOG 0-2, who receive neoadjuvant chemoimmunotherapy and are planned for curative-intent robotic sleeve lobectomy with systematic nodal dissection.
Not a fit: Patients with metastatic (M1) disease, those who received only chemotherapy without immunotherapy, those with prior systemic therapy or thoracic radiotherapy for the current cancer, or those deemed clearly unresectable would not be eligible and would not benefit from the study's applicability.
Why it matters
Potential benefit: If successful, the findings could help surgeons predict which patients are likely to have safe, complete robotic sleeve resections and reduce conversions and major complications.
How similar studies have performed: Minimally invasive and robotic sleeve lobectomies have been reported in small single-center series, but prospective multicenter data specifically after neoadjuvant chemoimmunotherapy are limited, making this setting relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * ECOG performance status 0-2 * Histologically confirmed NSCLC * AJCC 9th clinical stage IIB-III, M0, deemed resectable or potentially resectable by the multidisciplinary tumour discussion (MDT) * Planned neoadjuvant chemo-immunotherapy (PD-1/PD-L1 inhibitor + platinum doublet；additional neoadjuvant thoracic radiotherapy is allowed) * Planned curative-intent RATS sleeve lobectomy with systematic nodal dissection * Baseline and restaging imaging per protocol (CT ± PET-CT) * Complete 30-day postoperative follow-up * Ability to provide informed consent Exclusion Criteria: * Metastatic disease (M1) at baseline or on restaging. * No immunotherapy component in neoadjuvant regimen (pure chemotherapy) . * Prior systemic therapy or thoracic radiotherapy for the current cancer before starting chemo-IO. * Palliative intent or planned non-anatomic resection only (e.g., wedge) when sleeve/lobectomy is indicated oncologically. * Clear unresectability at restaging (e.g., multistation bulky N2/N3 not responding; unreconstructable T4 invasion) or MDT consensus against surgery. * Contraindication to general anesthesia or prohibitive cardiopulmonary risk precluding sleeve/lobectomy. * Active autoimmune disease requiring systemic immunosuppression within 2 years, prior organ transplant, or history of grade ≥2 pneumonitis/ILD * Uncontrolled infection, pregnancy or breastfeeding, or any intercurrent illness that would compromise participation.
Where this trial is running
Fuzhou, Fujian and 9 other locations
- Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Recruiting)
- Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Recruiting)
- Shenzhen People's Hospital — Shenzhen, Guangdong, China (Recruiting)
- Jiangsu Cancer Institute & Hospital — Nanjing, Jiangsu, China (Recruiting)
- The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (Recruiting)
- Tianjin Medical University Cancer Institute & Hospital — Tianjing, Tianjing, China (Recruiting)
- Shanghai Chest Hospital, Shanghai Jiao Tong University Medicine of School — Shanghai, China (Recruiting)
- Hôpital Saint Joseph Marseille — Marseille, France (Recruiting)
- University Hospital, Rouen — Rouen, France (Recruiting)
- Azienda Ospedaliera di Cosenza — Cosenza, Italy (Recruiting)
Study contacts
- Study coordinator: Zhigang Li, MD, PhD
- Email: zhigang.li@shsmu.edu.cn
- Phone: 0086-021-22200000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.