drugset / Trial / NCT03874000
Sintilimab Combined With Metformin in First-Line Chemotherapy Refractory Advanced NSCLC Patients
Phase 2
Unknown
43 enrolled
Tianjin Medical University Cancer Institute and Hospital
Innovent Biologics (Suzhou) Co. Ltd. · collab
NaSingle-groupOpen-labelTreatment
Summary
Evaluate the Efficacy and Safety of Sintilimab Combined with Metformin Hydrochloride in Patients with Advanced Non-small Cell Lung Cancer Refractory to First-Line Platinum-Containing Chemotherapy
Timeline
- Start
- 2019-03-08
- Primary completion
- 2022-02-28
- Completion
- 2022-06-05
Publications
- Results Kubo T, Ninomiya T, Hotta K, Kozuki T, Toyooka S, Okada H, Fujiwara T, Udono H, Kiura K. Study Protocol: Phase-Ib Trial of Nivolumab Combined With Metformin for Refractory/Recurrent Solid Tumors. Clin Lung Cancer. 2018 Nov;19(6):e861-e864. doi: 10.1016/j.cllc.2018.07.010. Epub 2018 Aug 9.
- Results Afzal MZ, Mercado RR, Shirai K. Efficacy of metformin in combination with immune checkpoint inhibitors (anti-PD-1/anti-CTLA-4) in metastatic malignant melanoma. J Immunother Cancer. 2018 Jul 2;6(1):64. doi: 10.1186/s40425-018-0375-1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metformin | Small molecule | 500 mg | Oral |
| Subject | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |