Type

Range

Units

Status

Start Date

End Date

Financing

Study Design

Brief description/objective

This is a randomized, double-blind, three-arm, multicenter, Phase 3 study in adult subjects with ED-SCLC, who achieve Stable Disease, Partial Response or Complete Response after completion of platinum based first line chemotherapy. Approximately 810 subjects will be random-ized in a 1:1:1 ratio to treatment with either nivolumab monotherapy (Arm A), nivolumab/ipilimumab combination therapy (Arm B), or placebo (Arm C), and will be stratified according to the following factors:
• ECOG Performance Status: 0 vs 1
• Gender: Male vs Female
• Prophylactic Cranial Irradiation (PCI) following chemo-therapy: Yes vs No
The treatment arms are as follows:
Arm A:
Nivolumab 240 mg administered every 2 weeks as a 30 min IV infusion
Arm B:
Nivolumab 1 mg/kg (30 min IV infusion) and ipilimumab 3 mg/kg (90 minute IV infusion) every 3 weeks for four dos-es, followed by nivolumab 240 mg every 2 weeks.
Arm C:
Placebo
In order to maintain a blinded study, the schedule of inves-tigational and placebo treatments is divided into two 6-week cycles at the start of therapy, followed by ongoing 2-week cycles until discontinuation criteria are met. On-study tumor assessments will be conducted every 6 weeks (± 5 days) for the first 36 weeks. After Week 36, tumor assessments will be performed every 12 weeks (± 5 days) until disease progression. The total duration of the study from start of randomization to final analysis of OS is expected to be 30 months (18 months of accrual + 12 months of follow-up), assuming a constant accrual rate (45 subjects/month during 18 months). PFS will be analyzed prior to OS. Additional survival follow-up may continue for up to 5 years from the primary analysis of survival. The study will end once survival follow-up has concluded.