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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

Sponsor: SystImmune Inc. · Participants: 550 · Started: Aug 4, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07625644

Locations in the U.S.

ArkansasHighlands Oncology Group, Springdale (Not yet recruiting)
CaliforniaLos Alamitos Hematology/Oncology Medical Group, Glendale
MemorialCare Todd Cancer Institute, Long Beach
Valkyrie Clinical Trials, Los Angeles
FloridaTotal Health and Research Center, Miami (Not yet recruiting)
New JerseyAstera Cancer Care, East Brunswick
VirginiaVirginia 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.