RATS Sleeve Lobectomy After Neo-Chemo-IO for NSCLC

NCT07541521 | Recruiting DMC

• 1 other identifier: IS26045
• Study Type: observational
• Target: 100
• Locations: 3 countries
• Sites: 10

Brief 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.

Conditions

Stage IIB-III NSCLC; Sleeve Lobectomy; Robotic Surgery; Neoadjuvant Chemoimmunotherapy

Keywords

stage IIB-III NSCLC; sleeve lobectomy; robotic surgery; neoadjuvant chemoimmunotherapy; perioperative outcomes; difficulty of surgery

Outcome Measures

Primary Outcomes (1)

• Unsuccessful RATS Sleeve Lobectomy

  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.

  From enrollment to the end of treatment at 4 weeks

Secondary Outcomes (9)

• Subjective Surgical Difficulty Assessment

  From enrollment to the end of treatment at 1 day

• Specific Difficulty Factors

  From enrollment to the end of treatment at 1 day

• Fissure Development Grade

  From enrollment to the end of treatment at 1 day

• Pleural Adhesions

  From enrollment to the end of treatment at 1 day

• Hilar Fibrosis

  From enrollment to the end of treatment at 1 day

Other Outcomes (2)

• 30- and 90-day readmission rates

  From enrollment to the end of treatment up to 90 days

• 30- and 90-day mortality

  From enrollment to the end of treatment up to 90 days

Study Arms (1)

ⅡB-Ⅲ NSCLC following Neo-Chemo-IO & RATS sleeve lobectomy

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.

Procedure: Robot-assisted thoracoscopic surgery (RATS) sleeve lobectomy

Interventions

Robot-assisted thoracoscopic surgery (RATS) sleeve lobectomy PROCEDURE

After the neoadjuvant treatment reaches the expected effect (partial remission, complete remission, or stable disease), the patients will undergo RATS sleeve lobectomy.

ⅡB-Ⅲ NSCLC following Neo-Chemo-IO & RATS sleeve lobectomy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include adult patients aged ≥18 years with pathologically or clinically diagnosed stage IIB-III non-small cell lung cancer (NSCLC), no distant metastasis (M0), and no contraindications to neoadjuvant chemoimmunotherapy or surgery. Participants will be selected from patients planned to undergo neoadjuvant chemoimmunotherapy followed by curative-intent robot-assisted thoracoscopic surgery (RATS) sleeve lobectomy. Relevant perioperative, pathological, and postoperative follow-up data will be collected prospectively.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead
• The Affiliated Hospital of Qingdao University: collaborator
• Fujian Medical University Union Hospital: collaborator
• Guangdong Provincial People's Hospital: collaborator
• Tianjin Medical University Cancer Institute and Hospital: collaborator
• Jiangsu Cancer Institute & Hospital: collaborator
• Shenzhen People's Hospital: collaborator
• University Hospital, Rouen: collaborator
• Hopital Saint Joseph Marseille: collaborator
• Azienda Ospedaliera Cosenza: collaborator

Study Sites (10)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

Shenzhen People's Hospital

Shenzhen, Guangdong, 518020, China

RECRUITING

Jiangsu Cancer Institute & Hospital

Nanjing, Jiangsu, 210009, China

RECRUITING

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

RECRUITING

Tianjin Medical University Cancer Institute & Hospital

Tianjing, Tianjing, 300060, China

RECRUITING

Shanghai Chest Hospital, Shanghai Jiao Tong University Medicine of School

Shanghai, 200030, China

RECRUITING

Hôpital Saint Joseph Marseille

Marseille, 13001, France

RECRUITING

University Hospital, Rouen

Rouen, 76000, France

RECRUITING

Azienda Ospedaliera di Cosenza

Cosenza, 87100, Italy

RECRUITING

Related Publications (17)

• Chu 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 BACKGROUND

• Sepesi 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 BACKGROUND

• Bott 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 BACKGROUND

• Brunelli 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 BACKGROUND

• Li 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.

  PMID: 40250266 BACKGROUND

• Mathey-Andrews C, McCarthy M, Potter AL, Beqari J, Wightman SC, Liou D, Raman V, Jeffrey Yang CF. Safety and feasibility of minimally invasive lobectomy after neoadjuvant immunotherapy for non-small cell lung cancer. J Thorac Cardiovasc Surg. 2023 Aug;166(2):347-355.e2. doi: 10.1016/j.jtcvs.2022.12.006. Epub 2022 Dec 16.

  PMID: 36653251 BACKGROUND

• Cooper AJ, Garbo E, Arfe A, Conroy M, Shaverdian N, Bott M, Gorria T, Pecci F, Aldea M, Anagnostou V, Schoenfeld A, Gomez D, Forde PM, Awad MM, Jones DR, Ricciuti B, Chaft JE. Real-world outcomes of neoadjuvant chemoimmunotherapy in patients with nonsmall cell lung cancer: Predictors of surgery, pathologic complete response, and event-free survival. Cancer. 2025 Sep 15;131(18):e70081. doi: 10.1002/cncr.70081.

  PMID: 40923935 BACKGROUND

• Kneuertz PJ, Villamizar N, Altorki NK, Phillips JD, Schnorr P, Jones D, Scott S, D'Souza DM, Baiu I, Abdel-Rasoul M, Schmidt J, Nguyen DM, Merritt RE. Minimally invasive resection of non-small cell lung cancer after chemoimmunotherapy: A multicenter study in academic hospitals. J Thorac Cardiovasc Surg. 2025 Dec;170(6):1803-1812.e2. doi: 10.1016/j.jtcvs.2025.07.030. Epub 2025 Jul 25.

  PMID: 40716726 BACKGROUND

• Provencio M, Nadal E, Gonzalez-Larriba JL, Martinez-Marti A, Bernabe R, Bosch-Barrera J, Casal-Rubio J, Calvo V, Insa A, Ponce S, Reguart N, de Castro J, Mosquera J, Cobo M, Aguilar A, Lopez Vivanco G, Camps C, Lopez-Castro R, Moran T, Barneto I, Rodriguez-Abreu D, Serna-Blasco R, Benitez R, Aguado de la Rosa C, Palmero R, Hernando-Trancho F, Martin-Lopez J, Cruz-Bermudez A, Massuti B, Romero A. Perioperative Nivolumab and Chemotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2023 Aug 10;389(6):504-513. doi: 10.1056/NEJMoa2215530. Epub 2023 Jun 28.

  PMID: 37379158 BACKGROUND

• Forde PM, Spicer JD, Provencio M, Mitsudomi T, Awad MM, Wang C, Lu S, Felip E, Swanson SJ, Brahmer JR, Kerr K, Taube JM, Ciuleanu TE, Tanaka F, Saylors GB, Chen KN, Ito H, Liberman M, Martin C, Broderick S, Wang L, Cai J, Duong Q, Meadows-Shropshire S, Fiore J, Bhatia S, Girard N; CheckMate 816 Investigators. Overall Survival with Neoadjuvant Nivolumab plus Chemotherapy in Lung Cancer. N Engl J Med. 2025 Aug 21;393(8):741-752. doi: 10.1056/NEJMoa2502931. Epub 2025 Jun 2.

  PMID: 40454642 BACKGROUND

• Liu A, Zhao Y, Qiu T, Xuan Y, Qin Y, Sun X, Xu R, Du W, Wu Z, Veronesi G, Amore D, Jiao W. The long-term oncologic outcomes of robot-assisted bronchial single sleeve lobectomy for 104 consecutive patients with centrally located non-small cell lung cancer. Transl Lung Cancer Res. 2022 May;11(5):869-879. doi: 10.21037/tlcr-22-298.

  PMID: 35693288 BACKGROUND

• Jin D, Dai Q, Han S, Wang K, Bai Q, Gou Y. Effect of da Vinci robot-assisted versus traditional thoracoscopic bronchial sleeve lobectomy. Asian J Surg. 2023 Oct;46(10):4191-4195. doi: 10.1016/j.asjsur.2022.11.029. Epub 2022 Nov 28.

  PMID: 36456441 BACKGROUND

• Catelli C, Corzani R, Zanfrini E, Franchi F, Ghisalberti M, Ligabue T, Meniconi F, Monaci N, Galgano A, Mathieu F, Addamo E, Sarnicola N, Fabiano A, Paladini P, Luzzi L. RoboticAssisted (RATS) versus Video-Assisted (VATS) lobectomy: A monocentric prospective randomized trial. Eur J Surg Oncol. 2023 Dec;49(12):107256. doi: 10.1016/j.ejso.2023.107256. Epub 2023 Oct 31.

  PMID: 37925829 BACKGROUND

• Oh DS, Reddy RM, Gorrepati ML, Mehendale S, Reed MF. Robotic-Assisted, Video-Assisted Thoracoscopic and Open Lobectomy: Propensity-Matched Analysis of Recent Premier Data. Ann Thorac Surg. 2017 Nov;104(5):1733-1740. doi: 10.1016/j.athoracsur.2017.06.020.

  PMID: 29054214 BACKGROUND

• Jin R, Zheng Y, Yuan Y, Han D, Cao Y, Zhang Y, Li C, Xiang J, Zhang Z, Niu Z, Lerut T, Lin J, Abbas AE, Pardolesi A, Suda T, Amore D, Schraag S, Aigner C, Li J, Che J, Hang J, Ren J, Zhu L, Li H. Robotic-assisted Versus Video-assisted Thoracoscopic Lobectomy: Short-term Results of a Randomized Clinical Trial (RVlob Trial). Ann Surg. 2022 Feb 1;275(2):295-302. doi: 10.1097/SLA.0000000000004922.

  PMID: 33938492 BACKGROUND

• Kent MS, Hartwig MG, Vallieres E, Abbas AE, Cerfolio RJ, Dylewski MR, Fabian T, Herrera LJ, Jett KG, Lazzaro RS, Meyers B, Mitzman BA, Reddy RM, Reed MF, Rice DC, Ross P, Sarkaria IS, Schumacher LY, Tisol WB, Wigle DA, Zervos M. Pulmonary Open, Robotic, and Thoracoscopic Lobectomy (PORTaL) Study: An Analysis of 5721 Cases. Ann Surg. 2023 Mar 1;277(3):528-533. doi: 10.1097/SLA.0000000000005115. Epub 2021 Sep 16.

  PMID: 34534988 BACKGROUND

• Harris RA, Law JJ, Hao L, Situ D, Dittberner FA, Bendixen M, Licht PB, Rogers CA, Lim E. Survival outcome of VATS compared with open lobectomy for lung cancer: an individual patient data meta-analysis of randomised trials. Lancet. 2026 Mar 21;407(10534):1182-1190. doi: 10.1016/S0140-6736(26)00031-0.

  PMID: 41864749 BACKGROUND

Study Officials

• Zhigang Li, MD, PhD

  Shanghai Chest Hospital, Shanghai Jiao Tong University Medicine of School

  STUDY CHAIR

Central Study Contacts

Zhigang Li, MD, PhD

CONTACT

0086-021-22200000; zhigang.li@shsmu.edu.cn

Lin Huang, MD, PhD

CONTACT

008618116061178; dr.huang.lin@shsmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 21, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2); IT (1); CN (7)