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

April 7, 2026 updated by: Zhigang Li, Shanghai Chest Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Please check all details of this study in Clinicaltrials.gov

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China, 200030
        • Recruiting
        • Shanghai Chest Hospital, Shanghai Jiao Tong University Medicine of School
        • Contact:
        • Contact:
          • Lin Huang, MD, PhD
          • Phone Number: 0086-18116061178
        • Principal Investigator:
          • Zhigang Li, MD, PhD
        • Sub-Investigator:
          • Lin Huang, MD, PhD
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:
        • Principal Investigator:
          • Bin Zheng, MD, PhD
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
        • Principal Investigator:
          • Wenzhao Zhong, MD, PhD
      • Shenzhen, Guangdong, China, 518020
        • Recruiting
        • Shenzhen People's Hospital
        • Contact:
          • Guangsuo Wang, MD, PhD
          • Phone Number: 0086-0755-25533018
          • Email: 908611104@qq.com
        • Principal Investigator:
          • Guangsuo Wang, MD, PhD
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Jiangsu Cancer Institute & Hospital
        • Contact:
        • Principal Investigator:
          • Ming Li, MD, PhD
    • Shandong
      • Qingdao, Shandong, China, 266000
        • Recruiting
        • The affiliated hospital of Qingdao university
        • Contact:
        • Principal Investigator:
          • Wenjie Jiao, MD, PhD
    • Tianjing
      • Tianjing, Tianjing, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:
        • Principal Investigator:
          • Jian You, MD, PhD
  • France
      • Marseille, France, 13001
        • Recruiting
        • Hôpital Saint Joseph Marseille
        • Contact:
        • Principal Investigator:
          • Ilies Bouabdallah, MD, PhD
      • Rouen, France, 76000
        • Recruiting
        • University Hospital, Rouen
        • Contact:
        • Principal Investigator:
          • Jean-Marc Baste, MD, PhD
  • Italy
      • Cosenza, Italy, 87100
        • Recruiting
        • Azienda Ospedaliera di Cosenza
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ralph Schmid, MD, PhD
        • Principal Investigator:
          • Franca Melfi, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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).

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
Robotic pulmonary surgery for patients with neoadjuvant chemo-immunotherapy for stage IIB-III non-small cell lung cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete resection (R0 resection)
Time Frame: From enrollment to the end of surgical treatment at 4 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay (LOS)
Time Frame: From enrollment to the end of the whole treatment in the index hospitalization
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.
From enrollment to the end of the whole treatment in the index hospitalization
Major postoperative complications
Time Frame: From enrollment to the end of the whole treatment at 3 months
Major postoperative complications were defined as any complication graded as Grade III or higher according to the Clavien-Dindo classification.
From enrollment to the end of the whole treatment at 3 months
Conversion to open
Time Frame: From enrollment to the end of surgical treatment
Conversion to open was defined as the intraoperative switch from a robotic-assisted procedure to an open surgical procedure.
From enrollment to the end of surgical treatment
Extended procedures
Time Frame: From enrollment to the end of surgical treatment
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.
From enrollment to the end of surgical treatment
30- and 90-day readmission rates
Time Frame: From enrollment to the end of treatment at 3 months
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.
From enrollment to the end of treatment at 3 months
30- and 90-day mortality
Time Frame: From enrollment to the end of treatment at 3 months
30- and 90-day mortality was defined as all-cause death occurring within 30 days and 90 days after the date of surgery, respectively.
From enrollment to the end of treatment at 3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days alive and out of hospital (DAOH)
Time Frame: From enrollment to the end of treatment at 3 months
DAOH is calculated as the follow-up duration minus days spent in hospital and days deceased.
From enrollment to the end of treatment at 3 months
Reoperation
Time Frame: From enrollment to the end of treatment at 3 months
Any unplanned surgical procedure performed during the same hospital admission or after discharge, due to postoperative complications, bleeding, infection, anastomotic leakage, or other surgical-related issues.
From enrollment to the end of treatment at 3 months
ICU admission
Time Frame: From enrollment to the end of treatment at 3 months
The requirement for postoperative admission to the intensive care unit for close monitoring, organ support, or management of severe complications.
From enrollment to the end of treatment at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Chest Hospital

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2026

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

March 30, 2027

Study Registration Dates

First Submitted

April 7, 2026

First Submitted That Met QC Criteria

April 7, 2026

First Posted (Actual)

April 14, 2026

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IS26036

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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