Clinical trial · Observational
RATS Sleeve Lobectomy After Neo-Chemo-IO for NSCLC
Robotic-Assisted Sleeve Lobectomy for Non-Small Cell Lung Cancer After Neoadjuvant Chemoimmunotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoadjuvant Chemoimmunotherapy | — | UNRESOLVED | — |
| Robotic Surgery | — | UNRESOLVED | — |
| Sleeve Lobectomy | — | UNRESOLVED | — |
| Stage IIB-III NSCLC | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Robot-assisted thoracoscopic surgery (RATS) sleeve lobectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- ⅡB-Ⅲ NSCLC following Neo-Chemo-IO & RATS sleeve lobectomy
- description
- All patients in this cohort will receive neoadjuvant chemo-immunotherapy (Neo-Chemo-IO) first for clinical stage IIB-III non-small cell lung cancer ( NSCLC), followed by robot-assisted thoracoscopic surgery (RATS) sleeve lobectomy.
- interventionNames
- Procedure: Robot-assisted thoracoscopic surgery (RATS) sleeve lobectomy
Primary outcomes (1)
- measure
- Unsuccessful RATS Sleeve Lobectomy
- timeFrame
- From enrollment to the end of treatment at 4 weeks
- description
- 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.
Secondary outcomes (9)
- measure
- Subjective Surgical Difficulty Assessment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (17)
- BACKGROUNDChu NQ, Tan KS, Dycoco J, Adusumilli PS, Bains MS, Bott MJ, Downey RJ, Gray KD, Huang J, Isbell JM, Molena D, Sihag S, Rocco G, Jones DR, Park BJ, Rusch VW. Determinants of successful minimally invasive surgery for resectable non-small cell lung cancer after neoadjuvant therapy. J Thorac Cardiovasc Surg. 2025 Mar;169(3):753-762.e6. doi: 10.1016/j.jtcvs.2024.08.012. Epub 2024 Aug 20. PMID 39168279
- BACKGROUNDSepesi B, Zhou N, William WN Jr, Lin HY, Leung CH, Weissferdt A, Mitchell KG, Pataer A, Walsh GL, Rice DC, Roth JA, Mehran RJ, Hofstetter WL, Antonoff MB, Rajaram R, Negrao MV, Tsao AS, Gibbons DL, Lee JJ, Heymach JV, Vaporciyan AA, Swisher SG, Cascone T. Surgical outcomes after neoadjuvant nivolumab or nivolumab with ipilimumab in patients with non-small cell lung cancer. J Thorac Cardiovasc Surg. 2022 Nov;164(5):1327-1337. doi: 10.1016/j.jtcvs.2022.01.019. Epub 2022 Jan 23. PMID 35190177
- BACKGROUNDBott MJ, Yang SC, Park BJ, Adusumilli PS, Rusch VW, Isbell JM, Downey RJ, Brahmer JR, Battafarano R, Bush E, Chaft J, Forde PM, Jones DR, Broderick SR. Initial results of pulmonary resection after neoadjuvant nivolumab in patients with resectable non-small cell lung cancer. J Thorac Cardiovasc Surg. 2019 Jul;158(1):269-276. doi: 10.1016/j.jtcvs.2018.11.124. Epub 2018 Dec 13. PMID 30718052
- BACKGROUNDBrunelli A, Hoffman R, Wotton R, Baijal S, Bhatnagar P, Clarke K, Escriu C, Fakih O, Franks K, Lodhia J, Nardini M, Naidu B, Shackcloth M. Surgical and Pathological Results Following Neoadjuvant Nivolumab and Platinum-Based Chemotherapy for Locally Advanced Resectable NSCLC: A Multicentre Real-World Series From England. Clin Lung Cancer. 2025 May;26(3):253-261. doi: 10.1016/j.cllc.2024.12.010. Epub 2024 Dec 25. PMID 39818517
- BACKGROUNDLi HJ, Ding JY, Nie Q, Hong HZ, Qiu ZB, Fu R, Zhang C, Zhang JT, Xu ZY, Yang J, Zhang S, Lin JT, Yang XN, Jiang BY, Zhong WZ. Advantages of robotic-assisted thoracic surgery after neoadjuvant therapy in NSCLC: A propensity score-matched analysis. Eur J Surg Oncol. 2025 Aug;51(8):110022. doi: 10.1016/j.ejso.2025.110022. Epub 2025 Apr 7.