drugset / Trial / NCT03085849
SGI-110 Plus Durvalumab/Tremelimumab in SCLC
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to determine if a combination of investigational agents is safe to give to people with small cell lung cancer (SCLC) after standard chemotherapy has been attempted. Subjects enrolled in this trial will receive 3 investigational drugs: SGI-110 (guadecitabine), durvalumab (MEDI4736) and tremelimumab.
Timeline
- Start
- 2017-12-15
- Primary completion
- 2018-11-26
- Completion
- 2018-11-26
Publications
- Background Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin. 2016 Jan-Feb;66(1):7-30. doi: 10.3322/caac.21332. Epub 2016 Jan 7.
- Background Chute JP, Chen T, Feigal E, Simon R, Johnson BE. Twenty years of phase III trials for patients with extensive-stage small-cell lung cancer: perceptible progress. J Clin Oncol. 1999 Jun;17(6):1794-801. doi: 10.1200/JCO.1999.17.6.1794.
- Background Janne PA, Freidlin B, Saxman S, Johnson DH, Livingston RB, Shepherd FA, Johnson BE. Twenty-five years of clinical research for patients with limited-stage small cell lung carcinoma in North America. Cancer. 2002 Oct 1;95(7):1528-38. doi: 10.1002/cncr.10841.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Durvalumab | Monoclonal antibody | 1500 mg | Intravenous |
| Subject | Guadecitabine | Oligonucleotide (other) | 20 mg/m2 | Subcutaneous |
| Subject | Guadecitabine | Oligonucleotide (other) | 30 mg/m2 | Subcutaneous |
| Subject | Guadecitabine | Oligonucleotide (other) | 45 mg/m2 | Subcutaneous |
| Subject | Tremelimumab | Monoclonal antibody | 75 mg | Intravenous |