Downstaging and RATS After Neo-Chemo-IO: Impact on Surgical Outcomes in NSCLC
Recruiting now
Conditions studied: Neoadjuvant Chemoimmunotherapy, Robotic Pulmonary Resection, Stage IIB-III NSCLC
In brief
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.
Key facts
- Study ID
- NCT07528066
- Run by
- Shanghai Chest Hospital
- People needed
- 200
- Starts
- 2026-03-02
- Expected to finish
- 2027-03-30
- Last updated by the study team
- 2026-04-14
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Fujian Medical University Union Hospital — Fuzhou, Fujian, China (enrolling)
- Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (enrolling)
- Shenzhen People's Hospital — Shenzhen, Guangdong, China (enrolling)
- Jiangsu Cancer Institute & Hospital — Nanjing, Jiangsu, China (enrolling)
- The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (enrolling)
- Tianjin Medical University Cancer Institute & Hospital — Tianjing, Tianjing, China (enrolling)
- Shanghai Chest Hospital, Shanghai Jiao Tong University Medicine of School — Shanghai, China (enrolling)
- Hôpital Saint Joseph Marseille — Marseille, France (enrolling)
- University Hospital, Rouen — Rouen, France (enrolling)
- Azienda Ospedaliera di Cosenza — Cosenza, Italy (enrolling)
Full record on ClinicalTrials.gov
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