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
Locations
6Sponsors and collaborators
The Affiliated Hospital of Qingdao University
Lead sponsor