Small-cell Lung Cancer Clinical Trial
Official title:
A Phase II Open-label, Single-arm Study Assessing the Efficacy and Safety of Combination Therapy of Sintilimab and Metformin With Relapsed PD-L1 Positive Small Cell Lung Cancer
In this Single arm study, histologically or cytologically confirmed ED-stage small cell lung
cancer (SCLC) patients resistant to or relapsed after standard chemotherapy will be enrolled
to investigate the Efficacy and Safety of a Combination of Sintilimab and Metformin.
Primary outcome:
Objective response rate (ORR), Safety of the combination therapy
Secondary outcome:
Overall survival (OS), Progression-free survival (PFS), Duration of response(DOR),
Exploratory Endpoints:
The association between the efficacy of the combination treatment and changes in CTC counts
after administration of the treatment.
Evaluating the correlation between programmed death ligand 1 (PD-L1) expression derived from
circulating tumor cells (CTC) and tumor tissue cells, and the predictive role of CTC PD-L1
expression in ED-SCLC.
The compositional changes in the gut microbiota after administration of the treatment and its
association with the efficacy of the combination treatment.
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