Downstaging and RATS After Neo-Chemo-IO: Impact on Surgical Outcomes in NSCLC

NCT07528066 | Recruiting DMC

• 1 other identifier: IS26036
• Study Type: observational
• Target: 200
• Locations: 3 countries
• Sites: 10

Brief Summary

The goal of this observational study is to learn whether tumor and nodal downstaging after neoadjuvant chemo-immunotherapy is associated with better surgical outcomes in patients with clinical stage IIB-III non-small cell lung cancer (NSCLC) undergoing robotic-assisted thoracic surgery. The main question it aims to answer is: Is downstaging after neoadjuvant chemo-immunotherapy associated with better surgical outcomes in patients with stage IIB-III NSCLC undergoing robotic-assisted surgery? Participants with resectable or potentially resectable stage IIB-III NSCLC who receive neoadjuvant chemo-immunotherapy as part of their routine clinical care and then undergo curative-intent robotic-assisted surgery will be prospectively enrolled from international centers. Clinical, operative, pathological, and postoperative outcome data will be collected, including R0 resection, the extent of resection, conversion to open surgery, postoperative complications, length of stay, readmission, and mortality.

Conditions

Neoadjuvant Chemoimmunotherapy; Robotic Pulmonary Resection; Stage IIB-III NSCLC

Keywords

stage IIB-III NSCLC; neoadjuvant chemo-immunotherapy; robotic-assisted surgery; perioperative outcomes

Outcome Measures

Primary Outcomes (1)

• Complete resection (R0 resection)

  R0 resection (complete resection) was defined according to the International Association for the Study of Lung Cancer (IASLC) criteria as: (1) microscopically negative resection margins; (2) systematic nodal dissection including at least 6 lymph node stations (3 N1 and 3 N2, including station 7); (3) no extracapsular nodal extension; and (4) the highest mediastinal lymph node removed being negative.

  From enrollment to the end of surgical treatment at 4 weeks

Secondary Outcomes (6)

• Length of stay (LOS)

  From enrollment to the end of the whole treatment in the index hospitalization

• Major postoperative complications

  From enrollment to the end of the whole treatment at 3 months

• Conversion to open

  From enrollment to the end of surgical treatment

• Extended procedures

  From enrollment to the end of surgical treatment

• 30- and 90-day readmission rates

  From enrollment to the end of treatment at 3 months

Other Outcomes (3)

• Days alive and out of hospital (DAOH)

  From enrollment to the end of treatment at 3 months

• Reoperation

  From enrollment to the end of treatment at 3 months

• ICU admission

  From enrollment to the end of treatment at 3 months

Study Arms (1)

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

Patients who are undergoing robotic-assisted thoracoscopic surgery for clinical stage ⅡB-Ⅲ non-small cell lung cancer following neoadjuvant chemoimmunotherapy

Procedure: Robotic-assisted surgery (RATS)

Interventions

Robotic-assisted surgery (RATS) PROCEDURE

Robotic pulmonary surgery for patients with neoadjuvant chemo-immunotherapy for stage IIB-III non-small cell lung cancer

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

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

This study will enroll patients aged ≥18 years with clinical stage ⅡB-Ⅲ non-small cell lung cancer (NSCLC). All enrolled patients will receive neoadjuvant chemoimmunotherapy (additional neoadjuvant RT is allowed) and then undergo robotic-assisted thoracoscopic surgery (RATS).

You may qualify if:

• Age ≥18 years
• 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 RT is allowed) with curative-intent surgery
• Received ≥1 cycle of chemo-IO (capture the intended 2-4 cycles)
• Baseline chest CT±PET-CT within 6 weeks before starting neoadjuvant therapy
• Restaging 2-6 weeks after last neoadjuvant dose with chest CT±PET-CT
• Curative-intent resection planned; surgery performed 2-10 weeks after last dose
• Performing systematic nodal dissection
• ECOG performance status 0-2.
• Complete 90-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 the neoadjuvant regimen (unless enrolled in a prespecified comparator cohort; otherwise exclude from primary analysis)
• Prior systemic therapy or thoracic radiotherapy for the current lung cancer before starting neoadjuvant chemo-IO
• Planned neoadjuvant chemoradiation (exclude unless including immunotherapy)
• Definitive decision against surgery before starting neoadjuvant therapy
• Active autoimmune disease requiring systemic immunosuppression within 2 years, prior organ transplant, or history of grade ≥2 pneumonitis/ILD
• Uncontrolled infection, pregnancy/lactation, or any condition precluding curative-intent resection per MDT

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
• Hopital Saint Joseph Marseille: collaborator
• University Hospital, Rouen: 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 (13)

• 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

• Li X, Li Q, Zhao E, Yang F, Gao E, Lin L, Li Y, Hu X, Zhu Y, Zhao D, Fan J, Song X, Duan L. Perioperative Outcomes of Robotic- vs Video-Assisted Thoracoscopic Surgery in Non-Small Cell Lung Cancer After Neoadjuvant Therapy. Ann Thorac Surg. 2025 Dec 26:S0003-4975(25)01261-5. doi: 10.1016/j.athoracsur.2025.12.003. Online ahead of print.

  PMID: 41456828 BACKGROUND

• Herrera LJ, Schumacher LY, Hartwig MG, Bakhos CT, Reddy RM, Vallieres E, Kent MS. Pulmonary Open, Robotic, and Thoracoscopic Lobectomy study: Outcomes and risk factors of conversion during minimally invasive lobectomy. J Thorac Cardiovasc Surg. 2023 Jul;166(1):251-262.e3. doi: 10.1016/j.jtcvs.2022.10.050. Epub 2022 Nov 15.

  PMID: 36509569 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

• Veronesi G, Park B, Cerfolio R, Dylewski M, Toker A, Fontaine JP, Hanna WC, Morenghi E, Novellis P, Velez-Cubian FO, Amaral MH, Dieci E, Alloisio M, Toloza EM. Robotic resection of Stage III lung cancer: an international retrospective study. Eur J Cardiothorac Surg. 2018 Nov 1;54(5):912-919. doi: 10.1093/ejcts/ezy166.

  PMID: 29718155 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

• Hawkins A, Martin LW. Operative Challenges After Induction Immunotherapy for Lung Cancer. Thorac Surg Clin. 2025 Aug;35(3):285-298. doi: 10.1016/j.thorsurg.2025.04.002. Epub 2025 Jun 6.

  PMID: 40619176 BACKGROUND

• Trabalza Marinucci B, Mancini M, Siciliani A, Messa F, Piccioni G, D'Andrilli A, Maurizi G, Ciccone AM, Menna C, Vanni C, Tiracorrendo M, Rendina EA, Ibrahim M. Surgical Techniques for Non-Small-Cell Lung Cancer After Neoadjuvant Chemo-Immunotherapy: State of Art and Review of the Literature. Cancers (Basel). 2025 Feb 14;17(4):638. doi: 10.3390/cancers17040638.

  PMID: 40002233 BACKGROUND

• Liu W, Tang J, Li X, Gong L, Yang D, Yin H, Wang W, Zhang B. Reduction in surgical scope after neoadjuvant chemotherapy and immunotherapy for non-small cell lung cancer. Oncol Lett. 2025 Aug 27;30(5):501. doi: 10.3892/ol.2025.15247. eCollection 2025 Nov.

  PMID: 40917729 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

• Sorin M, Prosty C, Ghaleb L, Nie K, Katergi K, Shahzad MH, Dube LR, Atallah A, Swaby A, Dankner M, Crump T, Walsh LA, Fiset PO, Sepesi B, Forde PM, Cascone T, Provencio M, Spicer JD. Neoadjuvant Chemoimmunotherapy for NSCLC: A Systematic Review and Meta-Analysis. JAMA Oncol. 2024 May 1;10(5):621-633. doi: 10.1001/jamaoncol.2024.0057.

  PMID: 38512301 BACKGROUND

• Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, Felip E, Broderick SR, Brahmer JR, Swanson SJ, Kerr K, Wang C, Ciuleanu TE, Saylors GB, Tanaka F, Ito H, Chen KN, Liberman M, Vokes EE, Taube JM, Dorange C, Cai J, Fiore J, Jarkowski A, Balli D, Sausen M, Pandya D, Calvet CY, Girard N; CheckMate 816 Investigators. Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer. N Engl J Med. 2022 May 26;386(21):1973-1985. doi: 10.1056/NEJMoa2202170. Epub 2022 Apr 11.

  PMID: 35403841 BACKGROUND

• Siegel RL, Kratzer TB, Giaquinto AN, Sung H, Jemal A. Cancer statistics, 2025. CA Cancer J Clin. 2025 Jan-Feb;75(1):10-45. doi: 10.3322/caac.21871. Epub 2025 Jan 16.

  PMID: 39817679 BACKGROUND

MeSH Terms

Interventions

Robotic Surgical Procedures

Intervention Hierarchy (Ancestors)

Surgery, Computer-Assisted; Surgical Procedures, Operative; Robotics; Automation; Technology; Technology, Industry, and Agriculture

Central Study Contacts

Zhigang Li, MD, PhD

CONTACT

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

Lin Huang, MD, PhD

CONTACT

0086-18116061178; 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 7, 2026
• First Posted: April 14, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-02

Locations

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