TrialPath
Recruiting

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

NCT07625644 · SystImmune Inc.
In plain English

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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
About this study
This study is a Global Phase 3, open-label, multicenter study designed to evaluate the efficacy and safety of BL-M14D1 in combination with atezolizumab compared with standard-of-care therapy in adult participants with previously untreated extensive-stage small cell lung cancer (ES-SCLC). Standard-of-care therapy consists of carboplatin plus etoposide chemotherapy and atezolizumab, followed by maintenance treatment with atezolizumab with or without lurbinectedin.
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.
Study design
Enrollment target: 550 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2026-08-04
Estimated completion: 2031-06
Last updated: 2026-09-15
Interventions
Drug: BL-M14D1 and AtezolizumabDrug: Carboplatin+ Etoposide + Atezolizumab followed by Atezolizumab and Lurbinectedin
Primary outcomes
  • Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR) (Up to approximately 2 years)
Sponsor
SystImmune Inc. · industry
Contacts & investigators
ContactLoren VanPelt · contact · loren.vanpelt@systimmune.com · 425-453-6841
InvestigatorSarah Tannenbaum, MD · study_director, SystImmune Inc.
All locations (62)
Highlands Oncology GroupNot Yet Recruiting
Springdale, Arkansas, United States
Los Alamitos Hematology/Oncology Medical GroupRecruiting
Glendale, California, United States
MemorialCare Todd Cancer InstituteRecruiting
Long Beach, California, United States
Valkyrie Clinical TrialsRecruiting
Los Angeles, California, United States
Total Health and Research CenterNot Yet Recruiting
Miami, Florida, United States
Astera Cancer CareRecruiting
East Brunswick, New Jersey, United States
Virginia Cancer SpecialistsRecruiting
Fairfax, Virginia, United States
Canberra HospitalNot Yet Recruiting
Garran, Australian Capital Territory, Australia
Tasman OncologyNot Yet Recruiting
Southport, Queensland, Australia
Flinders Medical CentreNot Yet Recruiting
Bedford Park, South Australia, Australia
MHAT Dr. Tota VenkovaNot Yet Recruiting
Gabrovo, Bulgaria
MHAT Heart and BrainNot Yet Recruiting
Pleven, Bulgaria
Medical Centre FutureMedsNot Yet Recruiting
Plovdiv, Bulgaria
MHAT PulmedNot Yet Recruiting
Plovdiv, Bulgaria
UMHAT Sveti Ivan RilskiNot Yet Recruiting
Sofia, Bulgaria
MHAT SerdikamedNot Yet Recruiting
Sofia, Bulgaria
Arthur Child Cancer CentreNot Yet Recruiting
Calgary, Alberta, Canada
University of SherbrookeNot Yet Recruiting
Greenfield Park, Quebec, Canada
Nemocnice České Budějovice, a.s.Not Yet Recruiting
České Budějovice, Czechia
Nemocnice Agel VítkoviceNot Yet Recruiting
Ostrava, Czechia
Fakultní nemocnice Ostrava (FN Ostrava)Not Yet Recruiting
Ostrava-Poruba, Czechia
Organization Centre Hospitalier Intercommunal de Creteil (CHIC) - Centre de Recherche Clinique (CRC) (Clinical Research Center)Not Yet Recruiting
Créteil, France
CLB - Centre Léon BérardNot Yet Recruiting
Lyon, France
IPC - lnstitut Paoli-CalmettesNot Yet Recruiting
Marseille, France
Universite Pierre et Marie Curie (UPMC) - Center de Recherche des Cordeliers (CRC)Not Yet Recruiting
Paris, France
ICO - L'Institut de Cancérologie de L'OuestNot Yet Recruiting
Saint-Herblain, France
LTD High Technology Hospital MedcenterNot Yet Recruiting
Tbilisi, Georgia
Ltd New HospitalsNot Yet Recruiting
Tbilisi, Georgia
Pineo Medical Ecosystem LtDNot Yet Recruiting
Tbilisi, Georgia
LLC Todua ClinicNot Yet Recruiting
Tbilisi, Georgia
The First Medical Clinic LLCNot Yet Recruiting
Tbilisi, Georgia
Caucasus Medical CentreNot Yet Recruiting
Tbilisi, Georgia
Lungenklinik/Lungenkrebszentrum Köln-MerheimNot Yet Recruiting
Cologne, Germany
KEM | Evangelische Kliniken Essen Mitte gGmbHNot Yet Recruiting
Essen, Germany
Krankenhaus Martha-Maria Halle-DölauNot Yet Recruiting
Halle, Germany
Henry Dunant Hospital CenterNot Yet Recruiting
Athens, Greece
Theageneio Anticancer HospitalNot Yet Recruiting
Thessaloniki, Greece
St Luke's HospitalNot Yet Recruiting
Thessaloniki, Greece
European Interbalkan Medical CenterNot Yet Recruiting
Thessaloniki, Greece
Semmelweis University Department of PulmonologyNot Yet Recruiting
Budapest, Hungary
Mátrai GyógyintézetNot Yet Recruiting
Gyöngyös, Hungary
Bács-Kiskun Vármegyei Oktatókórház, Oncoradiology CenterNot Yet Recruiting
Kecskemét, Hungary
Református Pulmonológiai IntézetNot Yet Recruiting
Törökbálint, Hungary
Centro di Riferimento OncologicoNot Yet Recruiting
Aviano, Italy
Policlinico Paolo Giaccone University HospitalNot Yet Recruiting
Palermo, Italy
Regina Elena Institute for Cancer ResearchNot Yet Recruiting
Roma, Italy
Fondazione Policlinico Universitario A. Gemelli IRCCSNot Yet Recruiting
Roma, Italy
AOUS Le Scotte, UOC Immunoterapia OncologicaNot Yet Recruiting
Siena, Italy
Uniwersytecki Szpital Kliniczny w Bialymstoku, II Klinika Chorob Pluc, Raka Pluca i Chorob WewnetrznychNot Yet Recruiting
Bialystok, Poland
Szpitale Pomorskie Spolka z ograniczona odpowiedzialnoscia, Oddzial Onkologii i Radioterapii - Dzial Onkologii KlinicznejNot Yet Recruiting
Gdynia, Poland
Oddzial Onkologii KlinicznejNot Yet Recruiting
Katowice, Poland
Instytut "Centrum Zdrowia Matki Polki", Klinika OnkologiiNot Yet Recruiting
Lodz, Poland
Szpital Specjalistyczny w Prabutach Spolka z ograniczona odpowiedzialnoscia, Oddzial pulmonologiiNot Yet Recruiting
Prabuty, Poland
University Clinical Centre of Serbia, Clinic for pulmonologyNot Yet Recruiting
Belgrade, Serbia
University Hospital Medical Center Bezanijska KosaNot Yet Recruiting
Belgrade, Serbia
University Clinical Center KragujevacNot Yet Recruiting
Kragujevac, Serbia
Institute for pulmonary diseases of VojvodinaNot Yet Recruiting
Novi Sad, Serbia
Complejo Hospitalario Universitario A Coruna (CHUAC) - Hospital Teresa HerreraNot Yet Recruiting
A Coruña, Spain
Hospital de la Santa Creu i Sant PauNot Yet Recruiting
Barcelona, Spain
Hospital Universitario Insular de Gran CanariaNot Yet Recruiting
Las Palmas de Gran Canaria, Spain
Hospital Clinico San CarlosNot Yet Recruiting
Madrid, Spain
Centro de Investigación Oncológica Clara CampalNot Yet Recruiting
Madrid, Spain
BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer (BrenDeLL-Lung01) · TrialPath