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DURVALUNG: Durvalumab Maintenance in Frail LD-SCLC
NCT05617963Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Mar 2023
- Primary completion
- Feb 2028
- Countries
- 1
- Sponsor
- Unicancer
- Modality
- Antibody Conjugates, Engineered Antibody Formats, PD-1/PD-L1 Inhibitors
- Drugs
- durvalumab
- Conditions
- Small Cell Lung Cancer (SCLC)
01
Overview
Phase 2, randomised, open-label trial of durvalumab in Small Cell Lung Cancer (SCLC), sponsored by Unicancer. Primary endpoint: Progression-Free Survival up to 3.5 years. Started Mar 2023; status: active, not recruiting.
02
Design
1 arm- Study design
- RandomizedOpen-label
Durvalumab maintenance
Patients receive durvalumab intravenously 1500 mg every 4 weeks until disease progression, unacceptable toxicity, death or patient's decision for a maximum of 24 months.
03
Who it enrols
Frail patients >=18 years with limited disease SCLC who achieved disease control after platinum-based thoracic chemoradiotherapy. Must have ECOG PS 2, or ECOG PS 0-1 and >70 years old, or ECOG PS 0-1 with comorbidities preventing concomitant CRT.
04
Endpoints
Primary
Progression-Free Survival
Secondary
Overall Survival
Adverse Events
Quality of Life Questionnaire - Core 30
Quality of Life Questionnaire - Lung Cancer Module
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