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.
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;
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.
Single group
Tislelizumab and nintedanib
DrugTislelizumab (200mgQ3W, D1) combined with nintedanib (150mg bid) until disease progression, death, or the occurrence of intolerable toxic reactions
progression-free survival（PFS）
The time from the randomization to the first occurrence of imaging disease progression or death
overall survival（OS）
The time from the first administration of the drug to death due to any cause
One-year progression-free survival rate
The incidence rate of radiation pneumonitis
Disease Control Rate
The proportion of patients whose tumors achieved remission (PR + CR) and stable lesions (SD).
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This trial is not recruiting at the moment. You can still explore other options:
