Study identifier:D419QC00001
ClinicalTrials.gov identifier:NCT03043872
EudraCT identifier:2016-001203-23
CTIS identifier:N/A
A Phase III, Randomized, Multicenter,Open-Label, Comparative Study to Determine the Efficacy of Durvalumab or Durvalumab and Tremelimumab in Combination With Platinum-Based Chemotherapy for the First-Line Treatment in Patients with Extensive Disease Small-Cell Lung Cancer (SCLC) (CASPIAN)
Small Cell Lung Carcinoma Extensive Disease
Phase 3
No
Durvalumab, Tremelimumab, Carboplatin, Cisplatin, Etoposide
All
987
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: Efficacy
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Jun 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Arm 1 durvalumab+tremelimumab+EP (carboplatin or cisplatin + etoposide) | Drug: Durvalumab IV infusions every 3 weeks for 12 weeks (4 cycles) and every 4 weeks thereafter until PD or other discontinuation criteria. Drug: Tremelimumab IV infusions every 3 weeks for 12 weeks(4 cycles). An additional dose of tremelimumab will be administered in the week 16. Drug: Carboplatin up to 4 cycles every 3 weeks in Arm 1 and 2, up to 6 cycles every 3 weeks in Arm 3 Drug: Cisplatin up to 4 cycles every 3 weeks in Arm 1 and 2, up to 6 cycles every 3 weeks in Arm 3 Drug: Etoposide up to 4 cycles every 3 weeks in Arm 1 and 2, up to 6 cycles every 3 weeks in Arm 3 |
Experimental: Arm 2 durvalumab+EP (carboplatin or cisplatin + etoposide) | Drug: Durvalumab IV infusions every 3 weeks for 12 weeks (4 cycles) and every 4 weeks thereafter until PD or other discontinuation criteria. Drug: Carboplatin up to 4 cycles every 3 weeks in Arm 1 and 2, up to 6 cycles every 3 weeks in Arm 3 Drug: Cisplatin up to 4 cycles every 3 weeks in Arm 1 and 2, up to 6 cycles every 3 weeks in Arm 3 Drug: Etoposide up to 4 cycles every 3 weeks in Arm 1 and 2, up to 6 cycles every 3 weeks in Arm 3 |
Active Comparator: Arm 3 EP (carboplatin or cisplatin + etoposide) | Drug: Carboplatin up to 4 cycles every 3 weeks in Arm 1 and 2, up to 6 cycles every 3 weeks in Arm 3 Drug: Cisplatin up to 4 cycles every 3 weeks in Arm 1 and 2, up to 6 cycles every 3 weeks in Arm 3 Drug: Etoposide up to 4 cycles every 3 weeks in Arm 1 and 2, up to 6 cycles every 3 weeks in Arm 3 |