Spots Global Cancer Trial Database for Assessing Safety and Efficacy of Sintilimab and Metformin Combination Therapy in SCLC

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Trial Identification

Brief Title: Assessing Safety and Efficacy of Sintilimab and Metformin Combination Therapy in SCLC

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

Study ID: NCT03994744

Conditions

Small-cell Lung Cancer

Small Cell Lung Carcinoma

Small Cell Lung Cancer Recurrent

Small Cell Lung Cancer Extensive Stage

Interventions

PD-1 inhibitor

Metformin

Study Description

Brief Summary: 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),

Detailed Description: 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.