A Prospective, Multicenter Exploratory Clinical Study on Consolidation Therapy With Tislelizumab Combined With Nintedanib for Limited-stage Small Cell Lung Cancer

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Affiliated Hospital of Qingdao University

About this trial

This study is a prospective, single-arm, multicenter, exploratory clinical trial. It aims to evaluate the efficacy and safety of tislelizumab combined with nintedanib as consolidation therapy for patients with limited-stage small cell lung cancer after concurrent chemoradiotherapy, and to explore the prognostic markers related to the therapeutic effect.

Eligibility criteria

Qualifiers

Have a thorough understanding of this study and have voluntarily signed the informed consent form;

Age ≥ 18 years old, gender not restricted;

ECOG score 0-1;

Histologically or cytologically confirmed as limited-stage small cell lung cancer;

Disqualifiers

There are patients with lung metastasis from other primary malignant tumors.

Patients who have previously or concurrently had other systemic malignant tumors (excluding skin basal cell carcinoma, skin squamous cell carcinoma, and/or in situ cancer that has undergone radical resection), excluding those with cured skin basal cell carcinoma, skin squamous cell carcinoma, and/or in situ cancer that has undergone radical resection.

Patients who have previously received other systemic treatments for the current lung cancer, including chemotherapy, immunotherapy, targeted therapy, or anti-angiogenic therapy, other than induction radiotherapy and chemotherapy.

Patients who received other approved systemic immunomodulators (including but not limited to interferon, interleukin-2, tumor necrosis factor, thymus pentapeptide, and thymalfasin) within 4 weeks prior to the first administration.

Trial design

Treatments tested in this trial

  • Tislelizumab and nintedanib

Treatment groups

20 Participants
are divided into 1 treatment group

Locations

6
Affiliated Hospital of Qingdao University QingdaoShandong, China
Qingdao Central Hospital Affiliated to Rehabilitation University QingdaoShandong, China
Qingdao Municipal Hospital QingdaoShandong, China
Weihai Municipal Hospital WeihaiShandong, China

Sponsors and collaborators

The Affiliated Hospital of Qingdao University

Lead sponsor