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

Study summary

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).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedBL-M14D1 and Atezolizumab and Carboplatin+ Etoposide + Atezolizumab followed by Atezolizumab and Lurbinectedin

The study team can explain what participation involves.

Who it may be forSmall cell lung cancer (SCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 15, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 3

Interventional

Where is it offered?62 U.S. locations

Locations may change over time.

Who runs it?SystImmune Inc.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 3
Sponsor: SystImmune Inc.
Interventions being studied: Drug: BL-M14D1 and Atezolizumab; Drug: Carboplatin+ Etoposide + Atezolizumab followed by Atezolizumab and Lurbinectedin

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Small cell lung cancer (SCLC)→

Disease setting

Metastatic or stage IV→

Treatment approach

Immunotherapy→Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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/

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Highlands Oncology GroupSpringdale, Arkansas
Los Alamitos Hematology/Oncology Medical GroupGlendale, California
MemorialCare Todd Cancer InstituteLong Beach, California
Valkyrie Clinical TrialsLos Angeles, California
Total Health and Research CenterMiami, Florida
Astera Cancer CareEast Brunswick, New Jersey
Virginia Cancer SpecialistsFairfax, Virginia
Canberra HospitalGarran, Australian Capital Territory
Tasman OncologySouthport, Queensland
Flinders Medical CentreBedford Park, South Australia
MHAT Dr. Tota VenkovaGabrovo
MHAT Heart and BrainPleven

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 15, 2026. Always confirm current availability with the study team.

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