Tumor downstaging and robotic lung surgery after pre‑operative chemo‑immunotherapy for stage IIB–III NSCLC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational study will enroll adults with resectable or potentially resectable clinical stage IIB–III NSCLC who receive planned neoadjuvant chemo‑immunotherapy and then undergo curative‑intent robotic‑assisted thoracic surgery. Clinical, operative, pathological, and 90‑day postoperative outcome data will be collected across participating centers, including R0 resection rates, extent of resection, conversion to open surgery, complications, length of stay, and readmissions. The main analysis will compare surgical and perioperative outcomes between patients who experience tumor and/or nodal downstaging after neoadjuvant therapy and those who do not. Standardized nodal dissection and restaging imaging are required to ensure comparable assessments of downstaging.

Why it matters

Who can join: the full rules

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

Where it's running

• Fujian Medical University Union Hospital
  Fuzhou, Fujian, China Recruiting
• Guangdong Provincial People's Hospital
  Guangzhou, Guangdong, China Recruiting
• Shenzhen People's Hospital
  Shenzhen, Guangdong, China Recruiting
• Jiangsu Cancer Institute & Hospital
  Nanjing, Jiangsu, China Recruiting
• The Affiliated Hospital of Qingdao University
  Qingdao, Shandong, China Recruiting
• Tianjin Medical University Cancer Institute & Hospital
  Tianjing, Tianjing, China Recruiting

Study contacts

• Study coordinator: Zhigang Li, MD, PhD
• Email: zhigang.li@shsmu.edu.cn
• Phone: 0086-021-22200000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.