The SCIENCE trial is a multicenter, open-label, randomized, parallel, noninferiority investigator-initiated trial (IIT). This study aims to evaluate the prognostic differences between selective mediastinal lymph node sampling and systematic mediastinal lymph node dissection in patients with node-negative stage IIA to IIIB (N2) non-small-cell lung cancer (NSCLC) undergoing anatomical lobectomy following neoadjuvant chemoimmunotherapy.
Voluntary participation with a signed written informed consent form.
Aged ≥ 18 and < 75 years, of either gender.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Anticipated life expectancy of ≥ 12 months.
Anticipated inability to tolerate an anatomical lobectomy;
Anticipated requirement for sleeve resection, pneumonectomy, or pulmonary autotransplantation to remove the affected lobe;
Prior thoracic radiotherapy before the initiation of surgical treatment;
History of allogeneic tissue or solid organ transplantation;
Parallel
selective mediastinal lymph node sampling
Procedure/SurgeryPatients randomized to the investigational group will undergo an anatomical lobectomy. Subsequently, no further lymph node resection or dissection will be performed in regional stations confirmed negative for metastasis by preoperative or intraoperative pathological evaluation (including negative preoperative endobronchial ultrasound \[EBUS\]-guided biopsies and negative intraoperative frozen sections). Postoperatively, patients will receive 1 cycle of platinum-based doublet chemotherapy combined with toripalimab immunotherapy, followed by 13 cycles of toripalimab immunotherapy.
systematic mediastinal lymph node dissection
Procedure/SurgeryPatients randomized to the control group will undergo a systematic mediastinal lymph node dissection following the completion of an anatomical lobectomy. A radical dissection and clearance of the mediastinal lymph nodes will be performed. For right-sided procedures, this encompasses the right upper paratracheal, right lower paratracheal, and subcarinal regions; for left-sided procedures, this encompasses the para-aortic, aortopulmonary window, left lower paratracheal, and subcarinal regions. Postoperatively, patients will receive 1 cycle of platinum-based doublet chemotherapy combined with toripalimab immunotherapy, followed by 13 cycles of toripalimab immunotherapy.
2-year event-free survival (EFS) rate
2-year disease-free survival (DFS) rate
2-year overall survival (OS) rate
Dynamic changes in absolute and relative peripheral blood lymphocyte counts
Length of hospital stay
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Wen-zhao ZHONG
Lead sponsor
Guangdong Provincial People's Hospital
Sponsor institution
Shanghai Junshi Bioscience Co., Ltd.
Collaborator
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