NCT03994744

Assessing Safety and Efficacy of Sintilimab and Metformin Combination Therapy in SCLC

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Hunan Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Small-cell Lung Cancer
• Small Cell Lung Carcinoma
• Small Cell Lung Cancer Recurrent
• Small Cell Lung Cancer Extensive Stage

Interventions

Type	Name	Description
DRUG	PD-1 inhibitor	Intravenous administration of Sintilimab (1200mg/3weeks)
DRUG	Metformin	Metformin treatment will be given (day20) 1 week before the second administration of Sintilimab at a dose of 2000 mg daily (1000mg BID). To reduce GI toxicity, participants start Metformin at 1000 mg daily (500mg am, 500 mg pm) for 1 week.

Timeline

• Start date: 2019-08-20
• Primary completion: 2021-08-01
• Completion: 2022-07-01
• First posted: 2019-06-21
• Last updated: 2019-08-28

Locations

1 site across 1 country: China