RATS Sleeve Lobectomy After Neo-Chemo-IO for NSCLC

NCT07541521 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Chest Hospital

Phase

Observational

Started

2026-04-13

Last updated

2026-04-21

Condition(s) studied

Stage IIB-III NSCLCSleeve LobectomyRobotic SurgeryNeoadjuvant Chemoimmunotherapy

Investigational drug(s) / intervention(s)

Robot-assisted thoracoscopic surgery (RATS) sleeve lobectomy

Robot-assisted thoracoscopic surgery (RATS) sleeve lobectomy: After the neoadjuvant treatment reaches the expected effect (partial remission, complete remission, or stable disease), the patients will undergo RATS sleeve lobectomy.

Study summary

The goal of this multicenter prospective observational study is to learn about the surgical difficulty and outcomes of robotic-assisted sleeve lobectomy in patients with non-small cell lung cancer (NSCLC) after neoadjuvant chemoimmunotherapy. The main questions it aims to answer are:

What is the rate of unsuccessful robotic-assisted sleeve lobectomy after neoadjuvant chemoimmunotherapy?

What factors are associated with unsuccessful surgery?

How do surgeons subjectively assess intraoperative difficulty across multiple dimensions during these procedures?

In this study, unsuccessful surgery is defined as any of the following: conversion to thoracotomy, incomplete (non-R0) resection, or major postoperative complications. Participants who are scheduled to undergo curative-intent robotic-assisted sleeve lobectomy as part of their routine clinical care after neoadjuvant chemoimmunotherapy will be enrolled from multiple centers. Clinical, intraoperative, pathological, and short-term postoperative data will be collected prospectively. In addition, surgeons will be asked to provide a multidimensional subjective assessment of intraoperative difficulty, including factors such as pleural adhesions, hilar fibrosis, nodal matting, fissure completeness, and vascular inflammation or edema, to better characterize the technical challenges of surgery and their association with perioperative outcomes.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Unsuccessful RATS Sleeve Lobectomy — From enrollment to the end of treatment at 4 weeks
The unsuccessful RATS sleeve lobectomy after neoadjuvant chemo-immunotherapy for NSCLC, defined as conversion to thoracotomy, non-R0 resection, or Clavien-Dindo grade ≥ III postoperative complications.

Trial sites (10)

Facility	City	Region	Status
Fujian Medical University Union Hospital	Fuzhou	Fujian	Recruiting
Guangdong Provincial People's Hospital	Guangzhou	Guangdong	Recruiting
Shenzhen People's Hospital	Shenzhen	Guangdong	Recruiting
Jiangsu Cancer Institute & Hospital	Nanjing	Jiangsu	Recruiting
The Affiliated Hospital of Qingdao University	Qingdao	Shandong	Recruiting
Tianjin Medical University Cancer Institute & Hospital	Tianjing	Tianjing	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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07541521 on ClinicalTrials.gov ↗ ← All trials in China