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

Shanghai Chest Hospital200 enrolled

Overview

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.

Please check all details of this study in Clinicaltrials.gov

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Neoadjuvant Chemoimmunotherapy Robotic Pulmonary Resection Stage IIB-III NSCLC

Interventions

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (10)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

RECRUITING

Shenzhen People's Hospital

Shenzhen, Guangdong, China

RECRUITING

Jiangsu Cancer Institute & Hospital

Nanjing, Jiangsu, China

RECRUITING

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

RECRUITING

Tianjin Medical University Cancer Institute & Hospital

Tianjing, Tianjing, China

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

Outcomes

Primary Outcomes

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 weeks

Secondary Outcomes

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 hospitalization

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 months

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 treatment

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 treatment

30- and 90-day readmission rates

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.

Time frame: From enrollment to the end of treatment at 3 months

30- and 90-day mortality

30- and 90-day mortality was defined as all-cause death occurring within 30 days and 90 days after the date of surgery, respectively.

Time frame: From enrollment to the end of treatment at 3 months

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

Overview

Conditions

Interventions

Eligibility

Locations (10)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts