drugset / Trial / NCT03994744
Assessing Safety and Efficacy of Sintilimab and Metformin Combination Therapy in SCLC
Phase 2
Unknown
68 enrolled
Hunan Cancer Hospital
Innovent Biologics (Suzhou) Co. Ltd. · collabXiangya Hospital of Central South University · collab
NaSingle-groupOpen-labelTreatment
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),
Timeline
- Start
- 2019-08-20
- Primary completion
- 2021-08-01
- Completion
- 2022-07-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metformin | Small molecule | 2000 mg | — |
| Subject | Sintilimab | Monoclonal antibody | 1200 mg | Intravenous |