Neoadjuvant Chemoimmunotherapy, Robotic Pulmonary Resection, Stage IIB-III NSCLC
Conditions
Keywords
stage IIB-III NSCLC, neoadjuvant chemo-immunotherapy, robotic-assisted surgery, perioperative outcomes
Brief 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.
Detailed description
Please check all details of this study in Clinicaltrials.gov
Interventions
PROCEDURERobotic-assisted surgery (RATS)
Robotic pulmonary surgery for patients with neoadjuvant chemo-immunotherapy for stage IIB-III non-small cell lung cancer
Sponsors
Shanghai Chest Hospital
The Affiliated Hospital of Qingdao University
Fujian Medical University Union Hospital
Guangdong Provincial People's Hospital
Tianjin Medical University Cancer Institute and Hospital
Jiangsu Cancer Institute & Hospital
Shenzhen People's Hospital
Hopital Saint Joseph Marseille
University Hospital, Rouen
Azienda Ospedaliera Cosenza
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay (LOS) | From enrollment to the end of the whole treatment in the index hospitalization | Length of stay is defined as the total number of nights from surgery to hospital discharge, calculated as the interval between the date of surgery and the date of discharge. |
| Major postoperative complications | From enrollment to the end of the whole treatment at 3 months | Major postoperative complications were defined as any complication graded as Grade III or higher according to the Clavien-Dindo classification. |
| Conversion to open | From enrollment to the end of surgical treatment | Conversion to open was defined as the intraoperative switch from a robotic-assisted procedure to an open surgical procedure. |
| Extended procedures | From enrollment to the end of surgical treatment | Extended procedures refer to additional or more extensive resections/reconstructions performed beyond standard lobectomy, including but not limited to bronchial sleeve resection, vascular angioplasty, pneumonectomy, chest wall resection, and other combined procedures. |
| 30- and 90-day readmission rates | From enrollment to the end of treatment at 3 months | 30- and 90-day readmission rates were defined as the proportion of patients who were readmitted to any hospital within 30 days and 90 days after the initial discharge, respectively. |
| 30- and 90-day mortality | From enrollment to the end of treatment at 3 months | 30- and 90-day mortality was defined as all-cause death occurring within 30 days and 90 days after the date of surgery, respectively. |
Countries
China, France, Italy
Contacts
CONTACTZhigang Li, MD, PhD
CONTACTLin Huang, MD, PhD
Outcome results
None listed