drugset / Trial / NCT04768296
Berzosertib + Topotecan in Relapsed Platinum-Resistant Small-Cell Lung Cancer (DDRiver SCLC 250)
Phase 2
Completed
76 enrolled
EMD Serono Research & Development Institute, Inc.
Merck KGaA, Darmstadt, Germany · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
The main purpose of this study is to assess efficacy, safety, tolerability and pharmacokinetics (PK) of Berzosertib in combination with Topotecan in participants with relapsed, platinum-resistant small-cell lung cancer (SCLC). This study will be conducted in two parts: safety run-in part and main part. The safety run-in part will be conducted in Japan.
Timeline
- Start
- 2021-03-29
- Primary completion
- 2023-07-21
- Completion
- 2023-07-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Berzosertib | Small molecule | 105 mg/m2 | Intravenous |
| Subject | Berzosertib | Small molecule | 210 mg/m2 | Intravenous |
| Background | Topotecan | Small molecule | 1.25 mg/m2 | Intravenous |