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

Recruitingn/aAges any - anyAllShanghai Chest Hospital
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In plain words

What the trial is, and whether it could suit you

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 rese

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📋 Eligibility rules (as published)
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
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What it tests

  • Robotic-assisted surgery (RATS)
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Where

10 sites
Fujian Medical University Union Hospital
Fuzhou, China
Guangdong Provincial People's Hospital
Guangzhou, China
Shenzhen People's Hospital
Shenzhen, China
Jiangsu Cancer Institute & Hospital
Nanjing, China
The Affiliated Hospital of Qingdao University
Qingdao, China
Tianjin Medical University Cancer Institute & Hospital
Tianjing, China
Shanghai Chest Hospital, Shanghai Jiao Tong University Medicine of School
Shanghai, China
Hôpital Saint Joseph Marseille
Marseille, France

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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