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BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer (BrenDeLL-Lung01)
RecruitingPhase 3
A Phase 3 Open-Label, Randomized Controlled Trial of BL-M14D1 and Atezolizumab vs. Standard-of-Care Therapy in Patients With First-Line Extensive-Stage Small Cell Lung Cancer
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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.
About the study
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).
What is being tested
- BL-M14D1 and Atezolizumab (drug)
- Carboplatin+ Etoposide + Atezolizumab followed by Atezolizumab and Lurbinectedin (drug)
Sponsor: SystImmune Inc. · Participants: 550 · Started: Aug 4, 2026
Contact the study team
- Loren VanPelt · Phone: 425-453-6841
Official record on ClinicalTrials.gov — NCT07625644
Locations in the U.S.
| Arkansas | Highlands Oncology Group, Springdale (Not yet recruiting) |
| California | Los Alamitos Hematology/Oncology Medical Group, Glendale MemorialCare Todd Cancer Institute, Long Beach Valkyrie Clinical Trials, Los Angeles |
| Florida | Total Health and Research Center, Miami (Not yet recruiting) |
| New Jersey | Astera Cancer Care, East Brunswick |
| Virginia | Virginia Cancer Specialists, Fairfax |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.