drugset / Trial / NCT04465968
Efficacy and Safety of CRT, Durvalumab and Surgery for SST
Phase 3
Not yet recruiting
84 enrolled
National Cancer Center Hospital East
AstraZeneca · collabJapan Agency for Medical Research and Development · collabJapan Clinical Oncology Group · collab
NaSingle-groupOpen-labelTreatment
Summary
The safety and efficacy of multimodality treatment of pre- and post-operative durvalumab therapy after pre-operative chemoradiotherapy for resectable superior sulcus tumor (SST) and durvalumab maintenance therapy after chemoradiotherapy for unresectable SST
Timeline
- Start
- 2020-09-01
- Primary completion
- 2027-08-31
- Completion
- 2030-08-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Durvalumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Background | Cisplatin | Other / unclassified | 60 mg/m2 | Intravenous |
| Background | S1 [arm: experimental] — 80 - 120 mg/day, PO, day 1-14 | Unknown | 80 mg | Oral |
| Background | S1 [arm: experimental] — 80 - 120 mg/day, PO, day 1-14 | Unknown | 120 mg | Oral |