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

Last updated: November 11, 2026
Sponsor: SystImmune Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Small Cell Lung Cancer

Neuroendocrine Carcinoma

Lung Disease

Treatment

Carboplatin+ Etoposide + Atezolizumab followed by Atezolizumab and Lurbinectedin

BL-M14D1 and Atezolizumab

Clinical Study ID

NCT07625644
BL-M14D1-LC-301
  • Ages > 18
  • All Genders

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).

Eligibility Criteria

Inclusion

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 combinationwith 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

Exclusion Criteria:

  • Received any kind of platinum or etoposide treatment for limited stage (LS) SCLCwithin 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 cellcarcinoma of the skin, squamous cell carcinoma of the skin and/or carcinoma in situafter adequate resection, or other malignancy treated with curative intent with adisease-free interval of at least 3 years

  • Other protocol-defined inclusion/exclusion criteria apply.

Study Design

Total Participants: 550
Treatment Group(s): 2
Primary Treatment: Carboplatin+ Etoposide + Atezolizumab followed by Atezolizumab and Lurbinectedin
Phase: 3
Study Start date:
August 04, 2026
Estimated Completion Date:
June 30, 2031

Study 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.

Connect with a study center

  • Canberra Hospital

    Garran, Australian Capital Territory 2605
    Australia

    Site Not Available

  • Tasman Oncology

    Southport, Queensland 4215
    Australia

    Site Not Available

  • Flinders Medical Centre

    Bedford Park, South Australia 5042
    Australia

    Site Not Available

  • One Clinical Research

    Nedlands, 6009
    Australia

    Site Not Available

  • MHAT Dr. Tota Venkova

    Gabrovo, 5300
    Bulgaria

    Site Not Available

  • MHAT Heart and Brain

    Pleven, 5800
    Bulgaria

    Site Not Available

  • Complex Oncology Center

    Plovdiv, 4000
    Bulgaria

    Site Not Available

  • MHAT Pulmed

    Plovdiv, 4002
    Bulgaria

    Site Not Available

  • Medical Centre FutureMeds

    Plovdiv, 1431
    Bulgaria

    Site Not Available

  • MHAT Serdikamed

    Sofia, 1632
    Bulgaria

    Site Not Available

  • UMHAT Sveti Ivan Rilski

    Sofia, 1431
    Bulgaria

    Suspended

  • Arthur Child Cancer Centre

    Calgary, Alberta T2N 5G2
    Canada

    Site Not Available

  • University of Sherbrooke

    Greenfield Park, Quebec J4V 2H1
    Canada

    Site Not Available

  • Nemocnice Agel Vítkovice

    Ostrava, 703 00
    Czechia

    Site Not Available

  • Fakultní nemocnice Ostrava (FN Ostrava)

    Ostrava-Poruba, 708 52
    Czechia

    Site Not Available

  • General University Hospital in Prague

    Prague, 128 08
    Czechia

    Site Not Available

  • Nemocnice České Budějovice, a.s.

    České Budějovice, 370 01
    Czechia

    Site Not Available

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

    Créteil, 94010
    France

    Site Not Available

  • CLB - Centre Léon Bérard

    Lyon, 69008
    France

    Site Not Available

  • IPC - lnstitut Paoli-Calmettes

    Marseille, 13273
    France

    Site Not Available

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

    Paris, 75005
    France

    Site Not Available

  • ICO - L'Institut de Cancérologie de L'Ouest

    Saint-Herblain, 44805
    France

    Site Not Available

  • Gustave Roussy

    Villejuif, 94805
    France

    Site Not Available

  • Caucasus Medical Centre

    Tbilisi, 0186
    Georgia

    Active - Recruiting

  • LLC Todua Clinic

    Tbilisi, 0119
    Georgia

    Active - Recruiting

  • LTD High Technology Hospital Medcenter

    Tbilisi, 0114
    Georgia

    Active - Recruiting

  • Ltd New Hospitals

    Tbilisi, 0114
    Georgia

    Active - Recruiting

  • Pineo Medical Ecosystem LtD

    Tbilisi, 0114
    Georgia

    Active - Recruiting

  • The First Medical Clinic LLC

    Tbilisi, 0180
    Georgia

    Active - Recruiting

  • Lungenklinik/Lungenkrebszentrum Köln-Merheim

    Cologne, 51109
    Germany

    Site Not Available

  • KEM | Evangelische Kliniken Essen Mitte gGmbH

    Essen, 45136
    Germany

    Site Not Available

  • Krankenhaus Martha-Maria Halle-Dölau

    Halle, 06120
    Germany

    Site Not Available

  • Henry Dunant Hospital Center

    Athens, 11526
    Greece

    Site Not Available

  • European Interbalkan Medical Center

    Thessaloniki, 57001
    Greece

    Site Not Available

  • St Luke's Hospital

    Thessaloniki, 55236
    Greece

    Site Not Available

  • Theageneio Anticancer Hospital

    Thessaloniki, 54639
    Greece

    Site Not Available

  • Semmelweis University Department of Pulmonology

    Budapest, 1083
    Hungary

    Site Not Available

  • Mátrai Gyógyintézet

    Gyöngyös, 7151
    Hungary

    Suspended

  • Bács-Kiskun Vármegyei Oktatókórház, Oncoradiology Center

    Kecskemét, 6000
    Hungary

    Site Not Available

  • Református Pulmonológiai Intézet

    Törökbálint, 2045
    Hungary

    Site Not Available

  • Fortis Hospital Bangalore

    Bangalore, 560076
    India

    Site Not Available

  • Erode Cancer Center

    Erode, 638012
    India

    Site Not Available

  • Sarvodaya Hospital and Research Institute

    Faridabad, 121006
    India

    Site Not Available

  • Malabar Cancer Centre

    Kannur, 670103
    India

    Site Not Available

  • IPGMER and SSKM Hospital

    Kolkata, 700020
    India

    Site Not Available

  • Noble Hospital Private Limited

    Pune, 411040
    India

    Site Not Available

  • Vendant Multispeciality Hospital

    Pune, 411019
    India

    Site Not Available

  • Nirmal Hospital Private Limited

    Surat, 395002
    India

    Site Not Available

  • Karnataka Medical College and Research Institute

    Vidyānagar, 580021
    India

    Site Not Available

  • Centro di Riferimento Oncologico

    Aviano, 33081
    Italy

    Site Not Available

  • Policlinico Paolo Giaccone University Hospital

    Palermo, 90127
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    Roma, 00168
    Italy

    Site Not Available

  • Regina Elena Institute for Cancer Research

    Roma, 00144
    Italy

    Site Not Available

  • AOUS Le Scotte, UOC Immunoterapia Oncologica

    Siena, 53100
    Italy

    Site Not Available

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

    Bialystok, 15-540
    Poland

    Site Not Available

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

    Gdynia, 81-519
    Poland

    Site Not Available

  • Oddzial Onkologii Klinicznej

    Katowice, 40-514
    Poland

    Site Not Available

  • Instytut "Centrum Zdrowia Matki Polki", Klinika Onkologii

    Lodz, 93-338
    Poland

    Site Not Available

  • Szpital Specjalistyczny w Prabutach Spolka z ograniczona odpowiedzialnoscia, Oddzial pulmonologii

    Prabuty, 82-550
    Poland

    Site Not Available

  • University Clinical Centre of Serbia, Clinic for pulmonology

    Belgrade, 11000
    Serbia

    Site Not Available

  • University Hospital Medical Center Bezanijska Kosa

    Belgrade, 11000
    Serbia

    Site Not Available

  • University Clinical Center Kragujevac

    Kragujevac, 34000
    Serbia

    Site Not Available

  • Institute for pulmonary diseases of Vojvodina

    Novi Sad, 21208
    Serbia

    Site Not Available

  • National Cancer Center

    Goyang-si, 10408
    South Korea

    Site Not Available

  • Cha University Bundang Medical Center

    Gyeonggi-do, 59
    South Korea

    Site Not Available

  • Chonnam National University Hwasun Hospital

    Jeongnam, 500
    South Korea

    Site Not Available

  • Korea University Guro Hospital

    Seoul, 08308
    South Korea

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul, 06230
    South Korea

    Site Not Available

  • The Catholic University of Korea Seoul St. Mary's Hospital

    Seoul, 222
    South Korea

    Site Not Available

  • St. Vincent's Hospital, The Catholic University in Korea

    Suwon, 16247
    South Korea

    Site Not Available

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

    A Coruña, 15006
    Spain

    Site Not Available

  • Hospital Universitario de Badajoz

    Badajoz, 06080
    Spain

    Site Not Available

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041
    Spain

    Site Not Available

  • Vall d'Hebron Institute of Oncology

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Universitario Insular de Gran Canaria

    Las Palmas de Gran Canaria, 35016
    Spain

    Site Not Available

  • Centro de Investigación Oncológica Clara Campal

    Madrid, 28050
    Spain

    Site Not Available

  • Hospital Clinico San Carlos

    Madrid, 28040
    Spain

    Site Not Available

  • Highlands Oncology Group

    Springdale, Arkansas 72762
    United States

    Active - Recruiting

  • OPN Healthcare

    Glendale, California 91203
    United States

    Active - Recruiting

  • MemorialCare Todd Cancer Institute

    Long Beach, California 90806
    United States

    Active - Recruiting

  • Valkyrie Clinical Trials

    Los Angeles, California 90067
    United States

    Active - Recruiting

  • Total Health and Research Center

    Miami, Florida 33176
    United States

    Active - Recruiting

  • Astera Cancer Care

    East Brunswick, New Jersey 08816
    United States

    Active - Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

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