Study identifier:D419BR00018
ClinicalTrials.gov identifier:NCT04449861
EudraCT identifier:N/A
CTIS identifier:N/A
An Open Label, Multicenter Study of First-Line Durvalumab plus Platinum-Based Chemotherapy in Chinese Patients with Extensive Stage Small-Cell Lung Cancer (Oriental)
Small Cell Lung Carcinoma Extensive Disease
Phase 3
No
Durvalumab plus chemotherapy
All
166
Interventional
18 Years - 130 Years
Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Durvalumab plus 4-6 cycles chemotherapy Participants will receive treatment with durvalumab + etoposide and either cisplatin or carboplatin (EP) for 4 to 6 cycles. Durvalumab will be administered at a dose of 1500 mg every 3 weeks (Q3W) with first-line chemotherapy (EP) and will continue to be administered as monotherapy every 4 weeks (Q4W) post-chemotherapy until progressive disease (PD). Prophylactic cranial irradiation (PCI) is allowed at the investigators’ discretion as per SoC guidance for ES-SCLC. Patients will attend a safety follow up visit 90 days after last dose of durvalumab. | - |