Durvalumab ± Tremelimumab in Combination With Platinum Based Chemotherapy in Untreated Extensive-Stage Small Cell Lung Cancer (CASPIAN)

Conditions

• Small Cell Lung Carcinoma Extensive Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - 130 Years

Healthy Volunteers

Not accepted

Interventions

• Durvalumab — DRUG
  IV infusions every 3 weeks for 12 weeks (4 cycles) and every 4 weeks thereafter until PD or other discontinuation criteria.
• Tremelimumab — DRUG
  IV infusions every 3 weeks for 12 weeks(4 cycles). An additional dose of tremelimumab will be administered in the week 16.
• Carboplatin — DRUG
  up to 4 cycles every 3 weeks in Arm 1 and 2, up to 6 cycles every 3 weeks in Arm 3
• Cisplatin — DRUG
  up to 4 cycles every 3 weeks in Arm 1 and 2, up to 6 cycles every 3 weeks in Arm 3
• Etoposide — DRUG
  up to 4 cycles every 3 weeks in Arm 1 and 2, up to 6 cycles every 3 weeks in Arm 3

Study Details

This is a phase III, randomized, open-label, multicenter, global study to determine the efficacy and safety of combining durvalumab ± tremelimumab with platinum based chemotherapy (EP) followed by durvalumab ± tremelimumab maintenance therapy versus EP alone as first-line treatment in patients with extensive-stage small-cell lung cancer

Key Dates

Start date

Mar 27, 2017

Status verified

Apr 2026

Primary completion

Jan 27, 2020

Completion

Dec 31, 2026

Study Design

Enrollment

987 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1
  durvalumab+tremelimumab+EP (carboplatin or cisplatin + etoposide)
• Experimental: Arm 2
  durvalumab+EP (carboplatin or cisplatin + etoposide)
• Active Comparator: Arm 3
  EP (carboplatin or cisplatin + etoposide)

Primary Outcome Measure

Overall Survival (OS) in the Global Cohort; Assessed at Global Cohort Interim Analysis; D + EP Compared With EP [ Time Frame: From baseline until death due to any cause. Assessed until global cohort interim analysis DCO (maximum of approximately 23 months). ]

Locations (19)

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