BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer (BrenDeLL-Lung01)

Sponsor
SystImmune Inc.
Study ID
NCT07625644
Phase
PHASE3
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Lung Cancer
  • Lung Cancer Metastatic
  • Lung Cancer Stage IV
  • SCLC,Extensive Stage
  • Sclc
  • Small Cell Carcinoma
  • Small Cell Lung Cancer Extensive Stage
  • Small-cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BL-M14D1 and Atezolizumab — DRUG
    BL-M14D1 administered in combination with atezolizumab. BL-M14D1 will be given intravenously at the protocol-specified dose and schedule. Atezolizumab will be administered intravenously according to the approved dosing regimen.
  • Carboplatin+ Etoposide + Atezolizumab followed by Atezolizumab and Lurbinectedin — DRUG
    Carboplatin and etoposide will be administered intravenously in combination with atezolizumab for induction therapy, followed by maintenance treatment with atezolizumab with or without lurbinectedin per protocol.

Study Details

The objective of the study is to evaluate the efficacy and safety of BL-M14D1 in combination with Atezolizumab compared to Standard-of-Care Therapy in adult participants with previously untreated extensive-stage small cell lung cancer (ES-SCLC).

Key Dates

First listed
Jun 4, 2026
Start date
Jun 30, 2026
Status verified
Jul 2026
Primary completion
Jan 31, 2030
Completion
Jun 30, 2031

Study Design

Enrollment
550 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    BL-M14D1: Administered on days 1 of every 21 days Atezolizumab: Administered dose on days 1 of every 21 days
  • Experimental: Arm B
    BL-M14D1: Administered on days 1 of every 21 days Atezolizumab: Administered dose on days 1 of every 21 days
  • Active Comparator: Arm C
    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)

Primary Outcome Measure

Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR) [ Time Frame: Up to approximately 2 years ]

Central Contacts

Find similar trials

Nationwide
Lung cancer trialsOncology trialsLung oncology trialsLung disease trials

Related Studies