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Neoadjuvant ChemoimmunotherapyDRAGON-NSCLCNCT07528066

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

An observational study of Neoadjuvant Chemoimmunotherapy and Robotic Pulmonary Resection, run by Shanghai Chest Hospital at 10 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Any age
What is being tested?
Robotic-assisted surgery (RATS)
Type of treatment
Surgery or procedure
How many people
200 participants
Where
10 sitesin 3 countries
Study dates
2 Mar 2026to 30 Mar 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: 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).

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

10 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

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

10 sites in 3 countries

China7 sites, 7 recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

    Bin Zheng, MD, PhD, 0086-0591-83357896, lacustrian@163.com

    Bin Zheng, MD, PhD

    Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510080

    Wenzhao Zhong, MD, PhD, 0086-020-83882222, 13609777314@163.com

    Wenzhao Zhong, MD, PhD

    Recruiting

  • Jiangsu Cancer Institute & Hospital

    Nanjing, Jiangsu, 210009

    Ming Li, MD, PhD, 0086-025-83283364, liming750523@163.com

    Ming Li, MD, PhD

    Recruiting

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266000

    Wenjie Jiao, MD, PhD, 0086-0532-96166, jiaowenjie@163.com

    Wenjie Jiao, MD, PhD

    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

    Guangsuo Wang, MD, PhD

    Recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjing, Tianjing, 300060

    Jian You, MD, PhD, 0086-022-23340123, youjiancn@126.com

    Jian You, MD, PhD

    Recruiting

Other trials in China

France2 sites, 2 recruiting

  • Hôpital Saint Joseph Marseille

    Marseille, 13001

    Ilies Bouabdallah, MD, PhD, +33 (0)4 91 80 65 00, ibouabdallah@hopital-saint-joseph.fr

    Ilies Bouabdallah, MD, PhD

    Recruiting

  • University Hospital, Rouen

    Rouen, 76000

    Jean-Marc Baste, MD, PhD, +33 (0)2 32 88 89 90, jean-marc.baste@chu-rouen.fr

    Jean-Marc Baste, MD, PhD

    Recruiting

Other trials in France

Italy1 site, 1 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

    Recruiting

Other trials in Italy

About this study

Official title: The Impact of Downstaging on Robotic Surgical Outcomes After Neoadjuvant Chemo-Immunotherapy in Non-Small Cell Lung Cancer

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.

Read the detailed description

Please check all details of this study in Clinicaltrials.gov

Being tested
Robotic-assisted surgery (RATS)
Keywords
stage IIB-III NSCLC, neoadjuvant chemo-immunotherapy, robotic-assisted surgery, perioperative outcomes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Robotic-assisted surgery (RATS)Procedure or surgery

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

Study groups in NCT07528066
Study groupRoleWhat they receive
ⅡB-Ⅲ NSCLC following Neo-Chemo-IO & RATSPatients who are undergoing robotic-assisted thoracoscopic surgery for clinical stage ⅡB-Ⅲ non-small cell lung cancer following neoadjuvant chemoimmunotherapy
Receives: Procedure: Robotic-assisted surgery (RATS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From enrollment to the end of surgical treatment at 4 weeks

Secondary outcomes (6)

  1. Length of stay (LOS)

    Length of stay is defined as the total number of nights 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 the whole treatment in the index hospitalization

  2. Major postoperative complications

    Major postoperative complications were defined as any complication graded as Grade III or higher according to the Clavien-Dindo classification.

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

  3. Conversion to open

    Conversion to open was defined as the intraoperative switch from a robotic-assisted procedure to an open surgical procedure.

    Measured: From enrollment to the end of surgical treatment

  4. Extended procedures

    Extended procedures refer to additional or more extensive resections/reconstructions performed beyond standard lobectomy, including but not limited to bronchial sleeve resection, vascular angioplasty, pneumonectomy, chest wall resection, and other combined procedures.

    Measured: From enrollment to the end of surgical treatment

  5. 30- and 90-day readmission rates

    30- and 90-day readmission rates were defined as the proportion of patients who were readmitted to any hospital within 30 days and 90 days after the initial discharge, respectively.

    Measured: From enrollment to the end of treatment at 3 months

  6. 30- and 90-day mortality

    30- and 90-day mortality was defined as all-cause death occurring within 30 days and 90 days after the date of surgery, respectively.

    Measured: From enrollment to the end of treatment at 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2026
  2. Study start2 Mar 2026
  3. Primary completion30 Mar 2027 (estimated)
  4. Study completion30 Mar 2027 (estimated)

Resources

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
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07528066
Sponsor's protocol ID
IS26036
Acronym
DRAGON-NSCLC
Status last verified
Feb 2026
First submitted
7 Apr 2026
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 35190177

  • 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. 2026 May;121(5):1184-1193. doi: 10.1016/j.athoracsur.2025.12.003. Epub 2025 Dec 26.

    PubMed 41456828

  • 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.

    PubMed 36509569

  • 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.

    PubMed 30718052

  • 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.

    PubMed 29718155

  • 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.

    PubMed 40716726

  • 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.

    PubMed 40619176

  • 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.

    PubMed 40002233

  • 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.

    PubMed 40917729

  • 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.

    PubMed 40923935

  • 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.

    PubMed 38512301

  • 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.

    PubMed 35403841

  • 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.

    PubMed 39817679

Questions about this trial

What is this clinical trial studying?

An observational study of Neoadjuvant Chemoimmunotherapy and Robotic Pulmonary Resection, 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 12 inclusion and 7 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 14 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?

Complete resection (R0 resection) (time frame: From enrollment to the end of surgical 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 NCT07528066, which also lists 13 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 14 Apr 2026.

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