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BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer (BrenDeLL-Lung01)
Sponsor: SystImmune Inc.
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).
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
550
Start Date
2026-08-04
Completion Date
2031-06
Last Updated
2026-10-15
Healthy Volunteers
No
Conditions
Interventions
BL-M14D1 and Atezolizumab
BL-M14D1 administered in combination with atezolizumab. BL-M14D1 will be given intravenously at the protocol-specified dose and schedule. Atezolizumab will be administered intravenously according to the approved dosing regimen.
Carboplatin+ Etoposide + Atezolizumab followed by Atezolizumab and Lurbinectedin
Carboplatin and etoposide will be administered intravenously in combination with atezolizumab for induction therapy, followed by maintenance treatment with atezolizumab with or without lurbinectedin per protocol.
Locations (62)
Highlands Oncology Group
Springdale, Arkansas, United States
OPN Healthcare
Glendale, California, United States
MemorialCare Todd Cancer Institute
Long Beach, California, United States
Valkyrie Clinical Trials
Los Angeles, California, United States
Total Health and Research Center
Miami, Florida, United States
Astera Cancer Care
East Brunswick, New Jersey, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Canberra Hospital
Garran, Australian Capital Territory, Australia
Tasman Oncology
Southport, Queensland, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
MHAT Dr. Tota Venkova
Gabrovo, Bulgaria
MHAT Heart and Brain
Pleven, Bulgaria
Medical Centre FutureMeds
Plovdiv, Bulgaria
MHAT Pulmed
Plovdiv, Bulgaria
UMHAT Sveti Ivan Rilski
Sofia, Bulgaria
MHAT Serdikamed
Sofia, Bulgaria
Arthur Child Cancer Centre
Calgary, Alberta, Canada
University of Sherbrooke
Greenfield Park, Quebec, Canada
Nemocnice České Budějovice, a.s.
České Budějovice, Czechia
Nemocnice Agel Vítkovice
Ostrava, Czechia
Fakultní nemocnice Ostrava (FN Ostrava)
Ostrava-Poruba, Czechia
Organization Centre Hospitalier Intercommunal de Creteil (CHIC) - Centre de Recherche Clinique (CRC) (Clinical Research Center)
Créteil, France
CLB - Centre Léon Bérard
Lyon, France
IPC - lnstitut Paoli-Calmettes
Marseille, France
Universite Pierre et Marie Curie (UPMC) - Center de Recherche des Cordeliers (CRC)
Paris, France
ICO - L'Institut de Cancérologie de L'Ouest
Saint-Herblain, France
LTD High Technology Hospital Medcenter
Tbilisi, Georgia
Ltd New Hospitals
Tbilisi, Georgia
Pineo Medical Ecosystem LtD
Tbilisi, Georgia
LLC Todua Clinic
Tbilisi, Georgia
The First Medical Clinic LLC
Tbilisi, Georgia
Caucasus Medical Centre
Tbilisi, Georgia
Lungenklinik/Lungenkrebszentrum Köln-Merheim
Cologne, Germany
KEM | Evangelische Kliniken Essen Mitte gGmbH
Essen, Germany
Krankenhaus Martha-Maria Halle-Dölau
Halle, Germany
Henry Dunant Hospital Center
Athens, Greece
Theageneio Anticancer Hospital
Thessaloniki, Greece
St Luke's Hospital
Thessaloniki, Greece
European Interbalkan Medical Center
Thessaloniki, Greece
Semmelweis University Department of Pulmonology
Budapest, Hungary
Mátrai Gyógyintézet
Gyöngyös, Hungary
Bács-Kiskun Vármegyei Oktatókórház, Oncoradiology Center
Kecskemét, Hungary
Református Pulmonológiai Intézet
Törökbálint, Hungary
Centro di Riferimento Oncologico
Aviano, Italy
Policlinico Paolo Giaccone University Hospital
Palermo, Italy
Regina Elena Institute for Cancer Research
Roma, Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy
AOUS Le Scotte, UOC Immunoterapia Oncologica
Siena, Italy
Uniwersytecki Szpital Kliniczny w Bialymstoku, II Klinika Chorob Pluc, Raka Pluca i Chorob Wewnetrznych
Bialystok, Poland
Szpitale Pomorskie Spolka z ograniczona odpowiedzialnoscia, Oddzial Onkologii i Radioterapii - Dzial Onkologii Klinicznej
Gdynia, Poland
Oddzial Onkologii Klinicznej
Katowice, Poland
Instytut "Centrum Zdrowia Matki Polki", Klinika Onkologii
Lodz, Poland
Szpital Specjalistyczny w Prabutach Spolka z ograniczona odpowiedzialnoscia, Oddzial pulmonologii
Prabuty, Poland
University Clinical Centre of Serbia, Clinic for pulmonology
Belgrade, Serbia
University Hospital Medical Center Bezanijska Kosa
Belgrade, Serbia
University Clinical Center Kragujevac
Kragujevac, Serbia
Institute for pulmonary diseases of Vojvodina
Novi Sad, Serbia
Complejo Hospitalario Universitario A Coruna (CHUAC) - Hospital Teresa Herrera
A Coruña, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, Spain
Hospital Clinico San Carlos
Madrid, Spain
Centro de Investigación Oncológica Clara Campal
Madrid, Spain