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Tumor shrinkage and robotic lung surgery after chemo-immunotherapy in non-small cell lung cancer

Looks at whether tumor shrinkage relates to surgical results in non-small cell lung cancer.

Key facts

Who runs it
Shanghai Chest Hospital
Where
Fuzhou, Guangzhou, Nanjing, Qingdao, Shanghai, Shenzhen, and Tianjing, ChinaSee the 7 sitesAlso in 2 other countries, 3 sites
Trial code
Registry title
Downstaging and RATS After Neo-Chemo-IO: Impact on Surgical Outcomes in NSCLC
Status
Recruiting
People taking part
200 people, planned
Started
2 Mar 2026
Expected to end
30 Mar 2027
Type of study
Observational
Treatments tested
  • Robotic-assisted surgery (RATS)
Record updated
14 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The study is looking for adults with stage IIB-III non-small cell lung cancer who get chemo-immunotherapy before surgery and then have robotic-assisted lung surgery.

Age
18 years or older
Sex
All sexes can join
Disease stage
Non-small cell lung cancer, clinical stage IIB-III (AJCC 9th), no spread to distant organs (M0), judged resectable or potentially resectable by the multidisciplinary tumour team
Earlier treatment
Must have had at least 1 cycle of chemo-immunotherapy (PD-1/PD-L1 inhibitor plus platinum doublet) before surgery; extra radiotherapy before surgery is allowed. Surgery 2-10 weeks after the last dose. No other cancer treatment or chest radiotherapy for this lung cancer before the chemo-immunotherapy.

Main reasons for not taking part

  • Cancer has spread to other organs (M1)
  • Active autoimmune disease needing immune-suppressing treatment within 2 years
  • Prior organ transplant
  • Past pneumonitis or interstitial lung disease of grade 2 or higher
  • Uncontrolled infection, pregnancy or breastfeeding

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Metastatic disease (M1) at baseline or on restaging
  • Uncontrolled infection, pregnancy/lactation, or any condition precluding curative-intent resection per MDT

Where in China

Also in 2 other countries, 3 sites

  • Fujian Medical University Union HospitalFuzhou, ChinaContact: Bin Zheng, MD, PhDTaking people
  • Guangdong Provincial People's HospitalGuangzhou, ChinaContact: Wenzhao Zhong, MD, PhDTaking people
  • Jiangsu Cancer Institute & HospitalNanjing, ChinaContact: Ming Li, MD, PhDTaking people
  • The Affiliated Hospital of Qingdao UniversityQingdao, ChinaContact: Wenjie Jiao, MD, PhDTaking people
  • Shanghai Chest Hospital, Shanghai Jiao Tong University Medicine of SchoolShanghai, ChinaContact: Zhigang Li, MD, PhDTaking people
  • Shenzhen People's HospitalShenzhen, ChinaContact: Guangsuo Wang, MD, PhDTaking people
  • Tianjin Medical University Cancer Institute & HospitalTianjing, ChinaContact: Jian You, MD, PhDTaking people

About the trial

What the trial wants to find out

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:

Read full original descriptionShow less

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.

The group in the trial

  • 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

    Treatment: Robotic-assisted surgery (RATS)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
The Impact of Downstaging on Robotic Surgical Outcomes After Neoadjuvant Chemo-Immunotherapy in Non-Small Cell Lung Cancer
Plain-language title
Tumor shrinkage and robotic lung surgery after chemo-immunotherapy in non-small cell lung cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
14 April 2026