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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorShanghai Chest Hospital

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Robotic-assisted surgery (RATS)

Treatment groups

200 Participants
are divided into 1 treatment group

Sponsors and collaborators

Shanghai Chest Hospital

Lead sponsor

The Affiliated Hospital of Qingdao University

Collaborator

Fujian Medical University Union Hospital

Collaborator

Guangdong Provincial People's Hospital

Collaborator

Tianjin Medical University Cancer Institute and Hospital

Collaborator

Jiangsu Cancer Institute & Hospital

Collaborator

Shenzhen People's Hospital

Collaborator

Hopital Saint Joseph Marseille

Collaborator

University Hospital, Rouen

Collaborator

Azienda Ospedaliera Cosenza

Collaborator