Stage IIB-III NSCLCRIDDLE-NSCLCNCT07541521
RATS Sleeve Lobectomy After Neo-Chemo-IO for NSCLC
An observational study of Stage IIB-III NSCLC and Sleeve Lobectomy, run by Shanghai Chest Hospital at 10 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stage IIB-III NSCLC, Sleeve Lobectomy, Robotic Surgery
- What is being tested?
- Robot-assisted thoracoscopic surgery (RATS) sleeve lobectomy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 13 Apr 2026to 30 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- Baseline and restaging imaging per protocol (CT ± PET-CT)
- Complete 30-day postoperative follow-up
- Ability to provide informed consent
Who cannot join
- 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.
Trial locations and contacts
10 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 3 countries
China7 sites, 7 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Bin Zheng, MD, PhD, 0086-0591-83357896, lacustrian@163.com
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Wenzhao Zhong, MD, PhD, 0086-020-83882222, 13609777314@163.com
- Recruiting
Jiangsu Cancer Institute & Hospital
Nanjing, Jiangsu, 210009
Ming Li, MD, PhD, 0086-025-83283364, liming750523@163.com
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Wenjie Jiao, MD, PhD, 0086-0532-96166, jiaowenjie@163.com
- Recruiting
Shanghai Chest Hospital, Shanghai Jiao Tong University Medicine of School
Shanghai, 200030
Zhigang Li, MD, PhD, 0086-021-22200000, zhigang.li@shsmu.edu.cn
Lin Huang, MD, PhD, 0086-18116061178
- Recruiting
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020
Guangsuo Wang, MD, PhD, 0086-0755-25533018, 908611104@qq.com
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjing, Tianjing, 300060
Jian You, MD, PhD, 0086-022-23340123, youjiancn@126.com
France2 sites, 2 recruiting
- Recruiting
Hôpital Saint Joseph Marseille
Marseille, 13001
Ilies Bouabdallah, MD, PhD, +33 (0)4 91 80 65 00, ibouabdallah@hopital-saint-joseph.fr
- Recruiting
University Hospital, Rouen
Rouen, 76000
Jean-Marc Baste, MD, PhD, +33 (0)2 32 88 89 90, jean-marc.baste@chu-rouen.fr
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliera di Cosenza
Cosenza, 87100
Ralph Schmid, MD, PhD, +39 0984 6811, ralph_a_schmid@hotmail.com
Franca Melfi, MD, PhD, +39 0984 6811, franca.melfi@unical.it
About this study
Official title: Robotic-Assisted Sleeve Lobectomy for Non-Small Cell Lung Cancer After Neoadjuvant Chemoimmunotherapy
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?
Read more
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.
Read the detailed description
Please check the details of this study on Clinicaltrials.gov
- Being tested
- Robot-assisted thoracoscopic surgery (RATS) sleeve lobectomy
- Keywords
- stage IIB-III NSCLC, sleeve lobectomy, robotic surgery, neoadjuvant chemoimmunotherapy, perioperative outcomes, difficulty of surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted thoracoscopic surgery (RATS) sleeve lobectomyProcedure or surgery
After the neoadjuvant treatment reaches the expected effect (partial remission, complete remission, or stable disease), the patients will undergo RATS sleeve lobectomy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Robot-assisted thoracoscopic surgery (RATS) sleeve lobectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (9)
Subjective Surgical Difficulty Assessment
The operating surgeon will rate the overall difficulty of the RATS sleeve lobectomy procedure using a 4-point Likert scale immediately after surgery: No difficulty, Some difficulty, Moderate difficulty, Severe difficulty.
Measured: From enrollment to the end of treatment at 1 day
Specific Difficulty Factors
The operating surgeon will also document the specific intraoperative challenges encountered during the procedure, with the following predefined options: Vascular inflammatory edema and fragility, Dense fibrosis, Pleural adhesions, Lymph node fusion and calcification, Incomplete fissure development
Measured: From enrollment to the end of treatment at 1 day
Fissure Development Grade
Grade I: Complete fissure; visceral pleura fully separates lobes with no parenchymal fusion at the fissure base; pulmonary artery lies centrally within the fissure.
Grade II: Complete fissure line, but parenchymal fusion ≤ 1 cm at the base; pulmonary artery remains visible within the fissure.
Grade III: Incomplete fissure; only partial fissure line visible with parenchymal fusion elsewhere; pulmonary artery partially or completely buried within fused parenchyma.
Grade IV: Complete fissural fusion with no visible fissure line; pulmonary artery deeply embedded in fused parenchyma requiring tunnel dissection.
Measured: From enrollment to the end of treatment at 1 day
Pleural Adhesions
- Definition Dense adhesions: Type II-III adhesions requiring sharp dissection, fibrotic, hypervascular, thick, band-like or sheet-like, prone to bleeding (type II) or fibrotic, scar-like, non-delineated fusion (type III). Overall adhesions: All adhesions including loose and dense.
- Grading None (0%) Mild: Dense adhesions < 10% AND overall adhesions < 30% Moderate: Dense adhesions < 10% AND overall adhesions > 70%; OR dense adhesions 10-30% AND overall adhesions 30-70% Severe: Dense adhesions 30-50% AND overall adhesions 30-70%; OR dense adhesions 10-30% AND overall adhesions > 70% Extremely severe: Dense adhesions > 50%; OR dense adhesions 30-50% AND overall adhesions > 70%
Measured: From enrollment to the end of treatment at 1 day
Hilar Fibrosis
None Mild: Localized fibrosis with clear planes from vital structures; safely dissectible with careful dissection.
Moderate: Dense fibrosis tightly adherent to vessels/bronchus; requires advanced sharp dissection and multiple energy devices with risk of bleeding or injury.
Severe: Hilar structures encased in a solid fibrotic scar mass; no safe dissection planes identifiable.
Measured: From enrollment to the end of treatment at 1 day
Lymph Node Fusion
None Mild: Nodes matted but with clear loose fibrous planes from vessels, bronchus, and nerves; completely dissectible without injury to key structures.
Moderate: Matted nodes densely adherent to vessel adventitia or bronchial wall with partial loss of dissection plane; may require piecemeal resection or leaving a thin fibrotic layer (confirmed tumor-free); increased bleeding risk.
Severe: Nodes fused and frozen to vital structures (main pulmonary artery, SVC, tracheal membrane) with no dissection plane identifiable.
Measured: From enrollment to the end of treatment at 1 day
Vascular Inflammatory Reaction / Edema
None Mild: Minimal edema with preserved tissue elasticity; clear dissection plane between vascular sheath and surrounding tissue, amenable to blunt dissection.
Moderate: Tofu-like or gelatinous tissue with increased fragility and oozing; vascular sheath densely adherent with blurred planes requiring delicate sharp dissection.
Severe: Extremely friable, necrotic inflammatory granulation tissue; complete loss of dissection planes; vessel wall fused with surrounding tissue and prone to rupture on dissection.
Measured: From enrollment to the end of treatment at 1 day
Need for Proximal Vascular Control
No Yes
Measured: From enrollment to the end of treatment at 1 day
Length of stay (LOS)
LOS is defined as the total number of night from surgery to hospital discharge, calculated as the interval between the date of surgery and the date of discharge.
Measured: From enrollment to the end of treatment up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start13 Apr 2026 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Stage IIB-III NSCLCStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Hospital of Qingdao University, Fujian Medical University Union Hospital, Guangdong Provincial People's Hospital, Tianjin Medical University Cancer Institute and Hospital, Jiangsu Cancer Institute & Hospital, Shenzhen People's Hospital, University Hospital, Rouen, Hopital Saint Joseph Marseille, Azienda Ospedaliera Cosenza
- Responsible party
- Principal investigator, Zhigang Li, Shanghai Chest Hospital
- Investigators
- Zhigang Li, MD, PhD, Study chair, Shanghai Chest Hospital, Shanghai Jiao Tong University Medicine of School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541521
- Sponsor's protocol ID
- IS26045
- Acronym
- RIDDLE-NSCLC
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39168279Sepesi 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.
PubMed 35190177Bott 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.
PubMed 30718052Brunelli 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.
PubMed 39818517Li 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.
PubMed 40250266Mathey-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.
PubMed 36653251Cooper 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.
PubMed 40923935Kneuertz 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.
PubMed 40716726Provencio 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.
PubMed 37379158Forde 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.
PubMed 40454642Liu 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.
PubMed 35693288Jin 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.
PubMed 36456441Catelli 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.
PubMed 37925829Oh 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.
PubMed 29054214Jin 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.
PubMed 33938492
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic-Assisted Sleeve Lobectomy for Non-Small Cell Lung Cancer After Neoadjuvant Chemoimmunotherapy
- ClinicalTrials.gov ID
- NCT07541521
- Acronym / sponsor ID
- RIDDLE-NSCLC / IS26045
- Keywords
- stage IIB-III NSCLC, sleeve lobectomy, robotic surgery, neoadjuvant chemoimmunotherapy, perioperative outcomes, difficulty of surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Collaborators
- The Affiliated Hospital of Qingdao University, Fujian Medical University Union Hospital, Guangdong Provincial People's Hospital, Tianjin Medical University Cancer Institute and Hospital, Jiangsu Cancer Institute & Hospital, Shenzhen People's Hospital, University Hospital, Rouen, Hopital Saint Joseph Marseille, Azienda Ospedaliera Cosenza
- Study start
- 13 Apr 2026 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Please check the details of this study on Clinicaltrials.gov
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ⅡB-Ⅲ NSCLC following Neo-Chemo-IO & RATS sleeve lobectomy | – | Procedure: Robot-assisted thoracoscopic surgery (RATS) sleeve lobectomyAll 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot-assisted thoracoscopic surgery (RATS) sleeve lobectomyAfter the neoadjuvant treatment reaches the expected effect (partial remission, complete remission, or stable disease), the patients will undergo RATS sleeve lobectomy. | Procedure or surgery | ⅡB-Ⅲ NSCLC following Neo-Chemo-IO & RATS sleeve lobectomy |
Primary outcome
Unsuccessful RATS Sleeve Lobectomy
Time frame: 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.
9 secondary outcomes
Subjective Surgical Difficulty Assessment
Time frame: From enrollment to the end of treatment at 1 day
Specific Difficulty Factors
Time frame: From enrollment to the end of treatment at 1 day
Fissure Development Grade
Time frame: From enrollment to the end of treatment at 1 day
Pleural Adhesions
Time frame: From enrollment to the end of treatment at 1 day
Hilar Fibrosis
Time frame: From enrollment to the end of treatment at 1 day
Lymph Node Fusion
Time frame: From enrollment to the end of treatment at 1 day
Vascular Inflammatory Reaction / Edema
Time frame: From enrollment to the end of treatment at 1 day
Need for Proximal Vascular Control
Time frame: From enrollment to the end of treatment at 1 day
Length of stay (LOS)
Time frame: From enrollment to the end of treatment up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Background: PubMed 39168279Chu 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.
- Background: PubMed 35190177Sepesi 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.
- Background: PubMed 30718052Bott 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.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhigang Li, MD, PhD study chair
Shanghai Chest Hospital, Shanghai Jiao Tong University Medicine of School
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stage IIB-III NSCLC and Sleeve Lobectomy, run by Shanghai Chest Hospital at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China, France, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhigang Li, MD, PhD (0086-021-22200000, zhigang.li@shsmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unsuccessful RATS Sleeve Lobectomy (time frame: From enrollment to the end of treatment at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07541521, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.