drugset / Trial / NCT04602533
Efficacy and Safety of Standard of Care Plus Durvalumab in Patients With Limited Disease Small Cell Lung Cancer (DOLPHIN)
RandomizedParallel-groupOpen-labelTreatment
Summary
Combination of concomitant Radio-Chemotherapy showed a significant improvement (Takada) of OS and PFS in limited disease SCLC patients. This clinical trial is a prospective, multicenter, randomized, open-label, parallel group phase II investigator initiated trial (ITT) to evaluate the efficacy and safety of Durvalumab in combination with Cisplatin/Etoposide/Radiotherapy in patients with limited disease small-cell lung cancer (SCLC).
Timeline
- Start
- 2020-12-21
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Durvalumab | Monoclonal antibody | 1500 mg | — |
| Background | Carboplatin | Small molecule | 2.5 unknown | — |
| Background | Carboplatin | Small molecule | 5 unknown | — |
| Background | Cisplatin | Other / unclassified | 40 mg/m2 | — |
| Background | Cisplatin | Other / unclassified | 75 mg/m2 | — |
| Background | Etoposide | Small molecule | 100 mg/m2 | — |