Robotic-assisted sleeve lobectomy after neoadjuvant chemoimmunotherapy for stage IIB-III non-small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Zhigang Li, MD, PhD
• Email: zhigang.li@shsmu.edu.cn
• Phone: 0086-021-22200000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.