About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Robotic-assisted surgery (RATS)
Treatment groups
Sponsors and collaborators
Shanghai Chest Hospital
Lead sponsor
The Affiliated Hospital of Qingdao University
Collaborator
Fujian Medical University Union Hospital
Collaborator
Guangdong Provincial People's Hospital
Collaborator
Tianjin Medical University Cancer Institute and Hospital
Collaborator
Jiangsu Cancer Institute & Hospital
Collaborator
Shenzhen People's Hospital
Collaborator
Hopital Saint Joseph Marseille
Collaborator
University Hospital, Rouen
Collaborator
Azienda Ospedaliera Cosenza
Collaborator