drugset / Trial / NCT03568097
Immunotherapy in Combination With Chemotherapy in Small-cell Lung Cancer
Phase 2
Unknown
55 enrolled
Hellenic Cooperative Oncology Group
Merck KGaA, Darmstadt, Germany · collab
NaSingle-groupOpen-labelTreatment
Summary
PAVE(Phased Avelumab combined with chemotherapy as first-line treatment for patients with advanced small-cell lung cancer) is a Greek, investigator- initiated, single arm open- label phase II study of Avelumab in combination with cisplatin or carboplatin/ etoposide. The study will include an initial safety run-in, open-label, singlearm part (Part 1), and the actual phase II study (Part 2). The total number of patients will not change (the safety run-in patients will be included in the final total number of participants). The safety run-in period will not alter the total study timelines, as phase II accrual will follow immediately after the safety run-in.
Timeline
- Start
- 2018-09-16
- Primary completion
- 2022-03-30
- Completion
- 2024-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Avelumab | Monoclonal antibody | 10 mg/kg | Intravenous |