MedTrace Logo

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

NCT07617389 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 358

Last updated 2026-06-01

No results posted yet for this study

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.

Conditions

  • Stage IIA-IIIB NSCLC
  • Selective Mediastinal Lymph Node Sampling
  • Systematic medIastinal Lymph Node Dissection

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.

Sponsors & Collaborators

  • Shanghai Junshi Bioscience Co., Ltd.

    collaborator OTHER

  • Wen-zhao ZHONG

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-20
Primary Completion
2030-05-15
Completion
2030-06-01

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07617389 on ClinicalTrials.gov