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NCT07625644RecruitingPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 15 Oct 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
550 (estimated)
First submitted
21 May 2026
Start date
4 Aug 2026
Primary completion date
Jan 2030
Lead sponsor
SystImmune Inc.
Diseases
Lung cancer
NCT number
NCT07625644

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 550
  • From 4 Aug 2026 to the primary completion date, Jan 2030
  • 62 sites in 14 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 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 illness

  • Participants with history of severe heart disease
  • Participants with active autoimmune diseases and inflammatory diseases,

Other

  • Other protocol-defined inclusion/exclusion criteria apply.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (62)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Flinders Medical Centre
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Bedford ParkAustraliaNot yet recruiting
Canberra Hospital
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GarranAustraliaNot yet recruiting
Tasman Oncology
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SouthportAustraliaNot yet recruiting
MHAT Dr. Tota Venkova
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GabrovoBulgariaNot yet recruiting
MHAT Heart and brain
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PlevenBulgariaNot yet recruiting
MHAT Pulmed
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PlovdivBulgariaNot yet recruiting
Medical Centre FutureMeds
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PlovdivBulgariaNot yet recruiting
UMHAT Sveti Ivan Rilski
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SofiaBulgariaNot yet recruiting
MHAT Serdikamed
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SofiaBulgariaNot yet recruiting
Arthur Child Cancer Centre
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CalgaryCanadaNot yet recruiting
University of Sherbrooke
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Greenfield ParkCanadaNot yet recruiting
Nemocnice České Budějovice, a.s.
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České BudějoviceCzechiaNot yet recruiting
Nemocnice Agel Vítkovice
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OstravaCzechiaNot yet recruiting
Fakultní nemocnice Ostrava (FN Ostrava)
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Ostrava-PorubaCzechiaNot yet recruiting
Lungenklinik/Lungenkrebszentrum Köln-Merheim
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CologneGermanyNot yet recruiting
KEM | Evangelische Kliniken Essen Mitte gGmbH
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EssenGermanyNot yet recruiting
Krankenhaus Martha-Maria Halle-Dolau
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HalleGermanyNot yet recruiting
Complejo Hospitalario Universitario A Coruna (CHUAC) - Hospital Teresa Herrera
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A CoruñaSpainNot yet recruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainNot yet recruiting
Hospital Universitario Insular de Gran Canaria
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Las Palmas de Gran CanariaSpainNot yet recruiting
Centro de Investigación Oncológica Clara Campal
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MadridSpainNot yet recruiting
Hospital Clínico San Carlos
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MadridSpainNot yet recruiting
Organization Centre Hospitalier Intercommunal de Creteil (CHIC) - Centre de Recherche Clinique (CRC) (Clinical Research Center)
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CréteilFranceNot yet recruiting
CLB - Centre Léon Bérard
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LyonFranceNot yet recruiting
IPC - lnstitut Paoli-Calmettes
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MarseilleFranceNot yet recruiting
Universite Pierre et Marie Curie (UPMC) - Center de Recherche des Cordeliers (CRC)
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ParisFranceNot yet recruiting
ICO - L'Institut de Cancérologie de L'Ouest
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Saint-HerblainFranceNot yet recruiting
Caucasus Medical Centre
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TbilisiGeorgiaNot yet recruiting
LTD "New Hospitals"
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TbilisiGeorgiaNot yet recruiting
The First Medical Clinic LLC
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TbilisiGeorgiaNot yet recruiting
Pineo Medical Ecosystem LtD
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TbilisiGeorgiaNot yet recruiting
LTD High Technology Hospital Medcenter
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TbilisiGeorgiaNot yet recruiting
Llc Todua Clinic
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TbilisiGeorgiaNot yet recruiting
Henry Dunant Hospital Center
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AthensGreeceNot yet recruiting
Theageneio Anticancer Hospital
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ThessalonikiGreeceNot yet recruiting
European Interbalkan Medical Center
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ThessalonikiGreeceNot yet recruiting
St. Luke's Hospital
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ThessalonikiGreeceNot yet recruiting
Semmelweis University Department of Pulmonology
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BudapestHungaryNot yet recruiting
Matrai Gyogyintezet
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GyöngyösHungaryNot yet recruiting
Bács-Kiskun Vármegyei Oktatókórház, Oncoradiology Center
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KecskemétHungaryNot yet recruiting
Református Pulmonológiai Intézet
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TörökbálintHungaryNot yet recruiting
Centro di Riferimento Oncologico
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AvianoItalyNot yet recruiting
Policlinico Paolo Giaccone University Hospital
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PalermoItalyNot yet recruiting
Regina Elena Institute for Cancer Research
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RomaItalyNot yet recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS
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RomaItalyNot yet recruiting
AOUS Le Scotte, UOC Immunoterapia Oncologica
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SienaItalyNot yet recruiting
Uniwersytecki Szpital Kliniczny w Bialymstoku, II Klinika Chorob Pluc, Raka Pluca i Chorob Wewnetrznych
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BialystokPolandNot yet recruiting
Szpitale Pomorskie Spolka z ograniczona odpowiedzialnoscia, Oddzial Onkologii i Radioterapii - Dzial Onkologii Klinicznej
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GdyniaPolandNot yet recruiting
Oddzial Onkologii Klinicznej
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KatowicePolandNot yet recruiting
Instytut "Centrum Zdrowia Matki Polki", Klinika Onkologii
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LodzPolandNot yet recruiting
Szpital Specjalistyczny w Prabutach Spolka z ograniczona odpowiedzialnoscia, Oddzial pulmonologii
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PrabutyPolandNot yet recruiting
University Hospital Medical Center Bezanijska Kosa
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BelgradeSerbiaNot yet recruiting
University Clinical Centre of Serbia, Clinic for pulmonology
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BelgradeSerbiaNot yet recruiting
University Clinical Center Kragujevac
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KragujevacSerbiaNot yet recruiting
Institute for pulmonary diseases of Vojvodina
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Novi SadSerbiaNot yet recruiting
Astera Cancer Care
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East BrunswickUnited StatesRecruiting
Virginia Cancer Specialists
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FairfaxUnited StatesRecruiting
OPN Healthcare
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GlendaleUnited StatesRecruiting
MemorialCare Todd Cancer Institute
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Long BeachUnited StatesRecruiting
Valkyrie Clinical Trials
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Los AngelesUnited StatesRecruiting
Total Health and Research Center
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MiamiUnited StatesRecruiting
Highlands Oncology Group
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SpringdaleUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.