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NOT YET RECRUITING
NCT07617389
PHASE3

Selective Mediastinal Lymph Node Sampling Versus Systematic medIastinal Lymph Node Dissection After Neoadjuvant Chemoimmunotherapy for Non-small Cell Lung Cancer (SCIENCE Study)

Sponsor: Wen-zhao ZHONG

View on ClinicalTrials.gov

Summary

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.

Official title: Selective Mediastinal Lymph Node Sampling Versus Systematic medIastinal Lymph Node Dissection After Neoadjuvant Chemotherapy Combined With Immunotherapy for the Treatment of Clinical Stage IIA-IIIB (N2) Non-small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

358

Start Date

2026-05-20

Completion Date

2030-06-01

Last Updated

2026-06-01

Healthy Volunteers

No

Interventions

PROCEDURE

selective mediastinal lymph node sampling

Patients 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.

PROCEDURE

systematic mediastinal lymph node dissection

Patients 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.

Locations (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China