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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorWen-zhao ZHONG

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • selective mediastinal lymph node sampling
  • systematic mediastinal lymph node dissection

Treatment groups

358 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Wen-zhao ZHONG

Lead sponsor

Guangdong Provincial People's Hospital

Sponsor institution

Shanghai Junshi Bioscience Co., Ltd.

Collaborator