drugset / Trial / NCT04525391
AZD2811 and Durvalumab (MEDI4736) Combination Therapy in Relapsed Small Cell Lung Cancer
NaSingle-groupOpen-labelTreatment
Summary
Samsung Medical Centre, Seoul, Korea. Additional 0\~5 Korea Lung Cancer Consortium (KLCC) centres in Korea Up to 40 subjects will be enrolled in two-stages (first stage: 19 evaluable subjects and second stage: 17 evaluable subjects and additional 4 subjects considering the drop out rate) If the study is conducted as de-escalated dosage (Durvalumab 1120mg) after the safety run-in, number of the patients will be counted from the second safety-run in phase.
Timeline
- Start
- 2020-09-18
- Primary completion
- 2022-01-14
- Completion
- 2022-01-14
Outcome
Outcome not reported
Stopped: “Recommended completion of the study due to SUSAR occurring in other clinical trials conducted with the same drug.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AZD2811 | Unknown | 500 mg | Intravenous |
| Subject | Durvalumab | Monoclonal antibody | 1120 mg | Intravenous |
| Subject | Durvalumab | Monoclonal antibody | 1500 mg | Intravenous |