NCT07528066Recruiting
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
Source: ClinicalTrials.gov · Last updated 14 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 7 Apr 2026
- Start date
- 2 Mar 2026
- Primary completion date
- 30 Mar 2027
- Lead sponsor
- Shanghai Chest Hospital
- Diseases
- Lung cancer, Childhood cancers
- NCT number
- NCT07528066
What you commit to
- Study type: Observational
- Planned participants: 200
- From 2 Mar 2026 to the primary completion date, 30 Mar 2027
- 10 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Metastatic disease (M1) at baseline or on restaging
- Uncontrolled infection, pregnancy/lactation, or any condition precluding curative-intent resection per MDT
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fujian Medical University Union Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| Guangdong Provincial People's Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Jiangsu Cancer Institute & Hospital Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| The Affiliated Hospital of Qingdao University Coordinator of this site? Confirm its status | Qingdao | China | Recruiting |
| Shanghai Chest Hospital, Shanghai Jiao Tong University Medicine of School Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Shenzhen People's Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Recruiting |
| Tianjin Medical University Cancer Institute & Hospital Coordinator of this site? Confirm its status | Tianjing | China | Recruiting |
| Hôpital Saint Joseph Marseille Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| University Hospital, Rouen Coordinator of this site? Confirm its status | Rouen | France | Recruiting |
| Azienda Ospedaliera di Cosenza Coordinator of this site? Confirm its status | Cosenza | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.