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
This trial does not accept healthy volunteersQualifiers
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 population
This study will enroll patients aged ≥18 years with clinical stage ⅡB-Ⅲ non-small cell lung cancer (NSCLC). All enrolled patients will receive neoadjuvant chemoimmunotherapy (additional neoadjuvant RT is allowed) and then undergo robotic-assisted thoracoscopic surgery (RATS).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Robotic-assisted surgery (RATS)
Procedure/SurgeryRobotic pulmonary surgery for patients with neoadjuvant chemo-immunotherapy for stage IIB-III non-small cell lung cancer
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: ⅡB-Ⅲ NSCLC following Neo-Chemo-IO & RATS1 intervention
Trial outcomes
Primary outcomes
1
Complete resection (R0 resection)
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.
Time frame
From enrollment to the end of surgical treatment at 4 weeksSecondary outcomes
1
Length of stay (LOS)
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.
Time frame
From enrollment to the end of the whole treatment in the index hospitalization2
Major postoperative complications
Major postoperative complications were defined as any complication graded as Grade III or higher according to the Clavien-Dindo classification.
Time frame
From enrollment to the end of the whole treatment at 3 months3
Conversion to open
Conversion to open was defined as the intraoperative switch from a robotic-assisted procedure to an open surgical procedure.
Time frame
From enrollment to the end of surgical treatment4
Extended procedures
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.
Time frame
From enrollment to the end of surgical treatmentOther outcomes
1
Days alive and out of hospital (DAOH)
DAOH is calculated as the follow-up duration minus days spent in hospital and days deceased.
Time frame
From enrollment to the end of treatment at 3 months2
Reoperation
Any unplanned surgical procedure performed during the same hospital admission or after discharge, due to postoperative complications, bleeding, infection, anastomotic leakage, or other surgical-related issues.
Time frame
From enrollment to the end of treatment at 3 months3
ICU admission
The requirement for postoperative admission to the intensive care unit for close monitoring, organ support, or management of severe complications.
Time frame
From enrollment to the end of treatment at 3 monthsSponsors and contacts
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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
Source ClinicalTrials.gov