NCT07625644
BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer (BrenDeLL-Lung01)
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Record History
All 6 versions: 5 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗
- Minor Trial sites expanded: 62 → 84 locations
- Minor Study sites revised (62)
Notable Recruitment opened Show 4 more changesShow less
- Eligibility criteria expanded, about 11 words
- Trial sites expanded: 0 → 62 locations
- Start date changed from estimate of Jun 2026 to Aug 4, 2026
- Secondary endpoints: details revised at 1 of 11 entries
- Minor Study title revisedv2
- Study First Submitted
- Notable: the plan changed
- Minor: routine updates
Endpoints
Primary
Secondary (11)
Show 6 moreShow less
Arms and interventions
BL-M14D1: Administered on days 1 of every 21 days Atezolizumab: Administered dose on days 1 of every 21 days
BL-M14D1: Administered on days 1 of every 21 days Atezolizumab: Administered dose on days 1 of every 21 days
Medications used in the Control Arm should be administered per local label or institutional guidelines. Induction therapy (4 cycles): Carboplatin (AUC of 5 mg/mL\*min IV) on Day 1 of each 21-day cycle Etoposide (100 mg/m2 IV) on Days 1 through 3 of each 21-day cycle Atezolizumab (1200 mg) IV on Day 1 of each 21-day cycle Maintenance therapy (continues until discontinuation criteria are met): Atezolizumab (1200 mg) IV on Day 1 of each 21-day cycle Lurbinectedin (3.2 mg/m2) IV on Day 1 of each 21-day cycle (to be added only if approved in region and as per PI discretion)
Drugs: BL-M14D1 and Atezolizumab, Carboplatin+ Etoposide + Atezolizumab followed by Atezolizumab and Lurbinectedin
Sites
84 sites in 16 countries
India 9, Bulgaria 7, South Korea 7, Spain 7, United States 7, France 6, Georgia 6, Italy 5, Poland 5, Australia 4, Czechia 4, Greece 4, Hungary 4, Serbia 4, Germany 3, Canada 2