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NCT07625644PHASE3Recruiting

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

SystImmune Inc.

Start Date

8/4/2026

Completion Date

6/1/2031

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).

Detailed Description

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

Age Range: 18 years to No maximum

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.

Interventions

DRUG

BL-M14D1 and Atezolizumab

DRUG

Carboplatin+ Etoposide + Atezolizumab followed by Atezolizumab and Lurbinectedin

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Conditions

Small Cell Lung Cancer Extensive StageSmall-cell Lung CancerSmall Cell CarcinomaSclcSCLC,Extensive StageLung CancerLung Cancer MetastaticLung Cancer Stage IV

Locations

Highlands Oncology Group

Springdale, Arkansas 72762

United States

Los Alamitos Hematology/Oncology Medical Group

Glendale, California 91203

United States

MemorialCare Todd Cancer Institute

Long Beach, California 90806

United States

Valkyrie Clinical Trials

Los Angeles, California 90067

United States

Total Health and Research Center

Miami, Florida 33176

United States

Astera Cancer Care

East Brunswick, New Jersey 08816

United States

Virginia Cancer Specialists

Fairfax, Virginia 22031

United States

Canberra Hospital

Garran, Australian Capital Territory 2605

Australia

Tasman Oncology

Southport, Queensland 4215

Australia

Flinders Medical Centre

Bedford Park, South Australia 5042

Australia

MHAT Dr. Tota Venkova

Gabrovo, 5300

Bulgaria

MHAT Heart and Brain

Pleven, 5800

Bulgaria

Medical Centre FutureMeds

Plovdiv, 1431

Bulgaria

MHAT Pulmed

Plovdiv, 4002

Bulgaria

UMHAT Sveti Ivan Rilski

Sofia, 1431

Bulgaria

MHAT Serdikamed

Sofia, 1632

Bulgaria

Arthur Child Cancer Centre

Calgary, Alberta T2N 5G2

Canada

University of Sherbrooke

Greenfield Park, Quebec J4V 2H1

Canada

Nemocnice České Budějovice, a.s.

České Budějovice, 370 01

Czechia

Nemocnice Agel Vítkovice

Ostrava, 703 00

Czechia

Fakultní nemocnice Ostrava (FN Ostrava)

Ostrava-Poruba, 708 52

Czechia

Organization Centre Hospitalier Intercommunal de Creteil (CHIC) - Centre de Recherche Clinique (CRC) (Clinical Research Center)

Créteil, 94010

France

CLB - Centre Léon Bérard

Lyon, 69008

France

IPC - lnstitut Paoli-Calmettes

Marseille, 13273

France

Universite Pierre et Marie Curie (UPMC) - Center de Recherche des Cordeliers (CRC)

Paris, 75005

France

ICO - L'Institut de Cancérologie de L'Ouest

Saint-Herblain, 44805

France

LTD High Technology Hospital Medcenter

Tbilisi, 0114

Georgia

Ltd New Hospitals

Tbilisi, 0114

Georgia

Pineo Medical Ecosystem LtD

Tbilisi, 0114

Georgia

LLC Todua Clinic

Tbilisi, 0119

Georgia

The First Medical Clinic LLC

Tbilisi, 0180

Georgia

Caucasus Medical Centre

Tbilisi, 0186

Georgia

Lungenklinik/Lungenkrebszentrum Köln-Merheim

Cologne, 51109

Germany

KEM | Evangelische Kliniken Essen Mitte gGmbH

Essen, 45136

Germany

Krankenhaus Martha-Maria Halle-Dölau

Halle, 06120

Germany

Henry Dunant Hospital Center

Athens, 11526

Greece

Theageneio Anticancer Hospital

Thessaloniki, 54639

Greece

St Luke's Hospital

Thessaloniki, 55236

Greece

European Interbalkan Medical Center

Thessaloniki, 57001

Greece

Semmelweis University Department of Pulmonology

Budapest, 1083

Hungary

Mátrai Gyógyintézet

Gyöngyös, 7151

Hungary

Bács-Kiskun Vármegyei Oktatókórház, Oncoradiology Center

Kecskemét, 6000

Hungary

Református Pulmonológiai Intézet

Törökbálint, 2045

Hungary

Centro di Riferimento Oncologico

Aviano, 33081

Italy

Policlinico Paolo Giaccone University Hospital

Palermo, 90127

Italy

Regina Elena Institute for Cancer Research

Roma, 00144

Italy

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168

Italy

AOUS Le Scotte, UOC Immunoterapia Oncologica

Siena, 53100

Italy

Uniwersytecki Szpital Kliniczny w Bialymstoku, II Klinika Chorob Pluc, Raka Pluca i Chorob Wewnetrznych

Bialystok, 15-540

Poland

Szpitale Pomorskie Spolka z ograniczona odpowiedzialnoscia, Oddzial Onkologii i Radioterapii - Dzial Onkologii Klinicznej

Gdynia, 81-519

Poland

Oddzial Onkologii Klinicznej

Katowice, 40-514

Poland

Instytut "Centrum Zdrowia Matki Polki", Klinika Onkologii

Lodz, 93-338

Poland

Szpital Specjalistyczny w Prabutach Spolka z ograniczona odpowiedzialnoscia, Oddzial pulmonologii

Prabuty, 82-550

Poland

University Clinical Centre of Serbia, Clinic for pulmonology

Belgrade, 11000

Serbia

University Hospital Medical Center Bezanijska Kosa

Belgrade, 11000

Serbia

University Clinical Center Kragujevac

Kragujevac, 34000

Serbia

Institute for pulmonary diseases of Vojvodina

Novi Sad, 21208

Serbia

Complejo Hospitalario Universitario A Coruna (CHUAC) - Hospital Teresa Herrera

A Coruña, 15006

Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041

Spain

Hospital Universitario Insular de Gran Canaria

Las Palmas de Gran Canaria, 35016

Spain

Hospital Clinico San Carlos

Madrid, 28040

Spain

Centro de Investigación Oncológica Clara Campal

Madrid, 28050

Spain