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NCT Number: NCT07528066

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

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.

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Key information

Conditions

Neoadjuvant Chemoimmunotherapy Robotic Pulmonary Resection Stage IIB-III NSCLC

Sex eligibility

All sexes

Study type

Observational

Primary location

Fujian Medical University Union Hospital, Fuzhou, Fujian, China

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About this study

Please check all details of this study in Clinicaltrials.gov

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robotic-assisted surgery (RATS)

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lin Huang, MD, PhD

CONTACT

[email protected]

0086-18116061178

Zhigang Li, MD, PhD

CONTACT

[email protected]

0086-021-22200000

Sponsors and collaborators

Lead sponsor

Shanghai Chest Hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: DRAGON-NSCLC

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 14, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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