RATS Sleeve Lobectomy After Neo-Chemo-IO for NSCLC (NCT07541521) | Clinical Trial Compass
RecruitingNot Applicable
RATS Sleeve Lobectomy After Neo-Chemo-IO for NSCLC
China, France, Italy100 participantsStarted 2026-04-13
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Unsuccessful RATS Sleeve Lobectomy
Timeframe: From enrollment to the end of treatment at 4 weeks