This prospective, single-arm, phase II study aims to evaluate the efficacy and safety of tislelizumab plus anlotinib as consolidation therapy in patients with limited-stage small cell lung cancer (LS-SCLC) who have not progressed following concurrent or sequential chemoradiotherapy.
Provide written informed consent and be willing and able to comply with study requirements and scheduled assessments;
Be aged 18-75 years at the time of consent;
Have an ECOG performance status of 0 or 1;
Have histologically or cytologically confirmed small-cell lung cancer;
Received systemic immunostimulatory agents, including interferons, interleukin 2, or tumour necrosis factor, within 4 weeks or five half-lives before the first dose of study treatment, whichever is longer; previous cancer vaccines are permitted;
Received any traditional Chinese herbal medicine for cancer control within 14 days before the first dose;
Required systemic corticosteroids equivalent to more than 10 mg per day of prednisone or other immunosuppressive treatment within 14 days before the first dose;
Received a live vaccine within 4 weeks before the first dose; inactivated seasonal influenza vaccines are permitted, but live intranasal influenza vaccines are not;
Single group
Tislelizumab + Anlotinib
DrugTislelizumab 200 mg on Day 1 plus anlotinib 10 mg on Days 1-14 of each 3-week cycle.
Progression Free Survival (PFS)
Overall Survival (OS)
6- and 12-month progression-free survival rates
Objective Response Rate (ORR)
Disease Control Rate (DCR)
Duration of Response (DoR)
Click on the lead sponsor to view all of their trials.
Yantai Yuhuangding Hospital
Lead sponsor
BeiGene
Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Collaborator
