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

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.

Please check all details of this study in Clinicaltrials.gov

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