BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer (BrenDeLL-Lung01)
Purpose
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).
Conditions
- Small Cell Lung Cancer Extensive Stage
- Small-cell Lung Cancer
- Small Cell Carcinoma
- Sclc
- SCLC,Extensive Stage
- Lung Cancer
- Lung Cancer Metastatic
- Lung Cancer Stage IV
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Histologically or cytologically confirmed first-line (1L), extensive-stage (ES) small cell lung cancer (SCLC) - Must be eligible to receive a platinum-based chemotherapy regimen in combination with an anti-PD-L1 inhibitor. - At least one measurable lesion based on RECIST v1.1 per investigator assessment. - An Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1. - Adequate organ function
Exclusion Criteria
- Received any kind of platinum or etoposide treatment for limited stage (LS) SCLC within 6 months prior to enrollment. - Participants who have received prior topoisomerase inhibitor-based ADC therapy. - Participants with history of severe heart disease - Participants with active autoimmune diseases and inflammatory diseases, - Participants with other prior or concurrent malignancies except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or carcinoma in situ after adequate resection, or other malignancy treated with curative intent with a disease-free interval of at least 3 years - Other protocol-defined inclusion/exclusion criteria apply.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
- Masking Description
- Blinded Independent Central Review (BICR)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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) |
|
Recruiting Locations
Los Alamitos Hematology/Oncology Medical Group
Glendale, California 91203
Glendale, California 91203
MemorialCare Todd Cancer Institute
Long Beach, California 90806
Long Beach, California 90806
Valkyrie Clinical Trials
Los Angeles, California 90067
Los Angeles, California 90067
Astera Cancer Care
East Brunswick, New Jersey 08816
East Brunswick, New Jersey 08816
Virginia Cancer Specialists
Fairfax, Virginia 22031
Fairfax, Virginia 22031
More Details
- Status
- Recruiting
- Sponsor
- SystImmune Inc.
Detailed Description
This study is a Global Phase 3, open-label, multicenter study designed to evaluate the efficacy and safety of BL-M14D1 in combination with atezolizumab compared with standard-of-care therapy in adult participants with previously untreated extensive-stage small cell lung cancer (ES-SCLC). Standard-of-care therapy consists of carboplatin plus etoposide chemotherapy and atezolizumab, followed by maintenance treatment with atezolizumab with or without lurbinectedin.