Tumor downstaging and robotic lung surgery after pre‑operative chemo‑immunotherapy for stage IIB–III NSCLC
The Impact of Downstaging on Robotic Surgical Outcomes After Neoadjuvant Chemo-Immunotherapy in Non-Small Cell Lung Cancer
This project will see if tumor and lymph node shrinkage after pre‑surgery chemo‑immunotherapy leads to safer operations and quicker recoveries for people with stage IIB–III non‑small cell lung cancer who have robotic lung surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Sex | All |
| Sponsor | Shanghai Chest Hospital Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 10 sites (Fuzhou, Fujian and 9 other locations) |
| Trial ID | NCT07528066 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with histologically confirmed, resectable or potentially resectable clinical stage IIB–III NSCLC who receive at least one cycle of planned neoadjuvant chemo‑immunotherapy and are fit for curative‑intent robotic resection (ECOG 0–2).
Not a fit: Patients with metastatic (M1) disease, those who did not receive an immunotherapy component preoperatively, or those who are not candidates for curative surgery are unlikely to benefit from this study's findings.
Why it matters
Potential benefit: If successful, the findings could help surgeons and patients predict who is most likely to have fewer complications and faster recoveries after robotic lung surgery following chemo‑immunotherapy.
How similar studies have performed: Prior trials have shown that neoadjuvant chemo‑immunotherapy can increase pathologic tumor and nodal responses and improve resectability, and robotic pulmonary resection is an established surgical approach, but prospective data directly linking downstaging after chemo‑IO to perioperative outcomes are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Fuzhou, Fujian and 9 other locations
- 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)
- Shanghai Chest Hospital, Shanghai Jiao Tong University Medicine of School — Shanghai, China (Recruiting)
- Hôpital Saint Joseph Marseille — Marseille, France (Recruiting)
- University Hospital, Rouen — Rouen, France (Recruiting)
- Azienda Ospedaliera di Cosenza — Cosenza, Italy (Recruiting)
Study contacts
- Study coordinator: Zhigang Li, MD, PhD
- Email: zhigang.li@shsmu.edu.cn
- Phone: 0086-021-22200000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.