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

NCT07528066 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Chest Hospital

Phase

Observational

Started

2026-03-02

Last updated

2026-04-14

Condition(s) studied

Neoadjuvant ChemoimmunotherapyRobotic Pulmonary ResectionStage IIB-III NSCLC

Investigational drug(s) / intervention(s)

Robotic-assisted surgery (RATS)

Robotic-assisted surgery (RATS): Robotic pulmonary surgery for patients with neoadjuvant chemo-immunotherapy for stage IIB-III non-small cell lung cancer

Study summary

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

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Complete resection (R0 resection) — From enrollment to the end of surgical treatment at 4 weeks
R0 resection (complete resection) was defined according to the International Association for the Study of Lung Cancer (IASLC) criteria as: (1) microscopically negative resection margins; (2) systematic nodal dissection including at least 6 lymph node stations (3 N1 and 3 N2, including station 7); (3) no extracapsular nodal extension; and (4) the highest mediastinal lymph node removed being negative.

Trial sites (10)

Facility	City	Region	Status
Fujian Medical University Union Hospital	Fuzhou	Fujian	Recruiting
Guangdong Provincial People's Hospital	Guangzhou	Guangdong	Recruiting
Shenzhen People's Hospital	Shenzhen	Guangdong	Recruiting
Jiangsu Cancer Institute & Hospital	Nanjing	Jiangsu	Recruiting
The Affiliated Hospital of Qingdao University	Qingdao	Shandong	Recruiting
Tianjin Medical University Cancer Institute & Hospital	Tianjing	Tianjing	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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07528066 on ClinicalTrials.gov ↗ ← All trials in China