Small Cell Lung Cancer Extensive StagePhase 3NCT07625644
BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer (BrenDeLL-Lung01)
A Phase 3 study testing BL-M14D1 and Atezolizumab and Carboplatin+ Etoposide + Atezolizumab followed by Atezolizumab and Lurbinectedin in people with Small Cell Lung Cancer Extensive Stage and Small-cell Lung Cancer, run by SystImmune Inc. at 62 sites in 14 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer Extensive Stage, Small-cell Lung Cancer, Small Cell Carcinoma
- What is being tested?
- BL-M14D1 and Atezolizumab and Carboplatin+ Etoposide + Atezolizumab followed by Atezolizumab and Lurbinectedin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 62 sitesin 14 countries
- Study dates
- 4 Aug 2026to Jun 2031
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
62 sites in 14 countries. Contact the study team or a site near you to ask about taking part.
62 sites in 14 countries
United States7 sites, 7 recruiting
- Recruiting
Astera Cancer Care
East Brunswick, New Jersey, 08816
Neel Belani
- Recruiting
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Alexander Spira
- Recruiting
OPN Healthcare
Glendale, California, 91203
Michael Nguyen
- Recruiting
MemorialCare Todd Cancer Institute
Long Beach, California, 90806
Nilesh Vora
- Recruiting
Valkyrie Clinical Trials
Los Angeles, California, 90067
Trenis Palmer, 912-398-3205, trenis.palmer@vctcare.com
David Berz
- Recruiting
Total Health and Research Center
Miami, Florida, 33176
Francisco Belette
- Recruiting
Highlands Oncology Group
Springdale, Arkansas, 72762
Eric Schaefer
Bulgaria6 sites, 6 recruiting
- Not yet recruiting
MHAT Dr. Tota Venkova
Gabrovo, 5300
Bonka Popova
- Not yet recruiting
MHAT Heart and Brain
Pleven, 5800
Natalia Chilingirova
- Not yet recruiting
Medical Centre FutureMeds
Plovdiv, 1431
Nikolay Shopov
- Not yet recruiting
MHAT Pulmed
Plovdiv, 4002
Yanislav Ilieva
- Not yet recruiting
UMHAT Sveti Ivan Rilski
Sofia, 1431
Bozhil Robrev
- Not yet recruiting
MHAT Serdikamed
Sofia, 1632
Krasimir Koynov
Georgia6 sites, 6 recruiting
- Not yet recruiting
LTD High Technology Hospital Medcenter
Tbilisi, 0114
Tamta Makharadze
- Not yet recruiting
Ltd New Hospitals
Tbilisi, 0114
David Giorgadze
- Not yet recruiting
Pineo Medical Ecosystem LtD
Tbilisi, 0114
Marita Gugunava
- Not yet recruiting
LLC Todua Clinic
Tbilisi, 0119
Tamar Melkadze
- Not yet recruiting
The First Medical Clinic LLC
Tbilisi, 0180
Nino Khupenia
- Not yet recruiting
Caucasus Medical Centre
Tbilisi, 0186
Ivane Kiladze
France5 sites, 5 recruiting
- Not yet recruiting
Organization Centre Hospitalier Intercommunal de Creteil (CHIC) - Centre de Recherche Clinique (CRC) (Clinical Research Center)
Créteil, 94010
Christos Chouaid
- Not yet recruiting
CLB - Centre Léon Bérard
Lyon, 69008
Romane Gille
- Not yet recruiting
IPC - lnstitut Paoli-Calmettes
Marseille, 13273
Philippe Rochigneux
- Not yet recruiting
Universite Pierre et Marie Curie (UPMC) - Center de Recherche des Cordeliers (CRC)
Paris, 75005
Nicolas Girard
- Not yet recruiting
ICO - L'Institut de Cancérologie de L'Ouest
Saint-Herblain, 44805
Ludovic Doucet
Italy5 sites, 5 recruiting
- Not yet recruiting
Centro di Riferimento Oncologico
Aviano, 33081
Elisa Bertoli
- Not yet recruiting
Policlinico Paolo Giaccone University Hospital
Palermo, 90127
Valerio Gristina
- Not yet recruiting
Regina Elena Institute for Cancer Research
Roma, 00144
Federico Cappuzzo
- Not yet recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, 00168
Emilio Bria
- Not yet recruiting
AOUS Le Scotte, UOC Immunoterapia Oncologica
Siena, 53100
Michele Maio
Poland5 sites, 5 recruiting
- Not yet recruiting
Uniwersytecki Szpital Kliniczny w Bialymstoku, II Klinika Chorob Pluc, Raka Pluca i Chorob Wewnetrznych
Bialystok, 15-540
Robert Mroz
- Not yet recruiting
Szpitale Pomorskie Spolka z ograniczona odpowiedzialnoscia, Oddzial Onkologii i Radioterapii - Dzial Onkologii Klinicznej
Gdynia, 81-519
Magdalena Wroblewska
- Not yet recruiting
Oddzial Onkologii Klinicznej
Katowice, 40-514
Jacek Kabut
- Not yet recruiting
Instytut "Centrum Zdrowia Matki Polki", Klinika Onkologii
Lodz, 93-338
Ewa Kalinka
- Not yet recruiting
Szpital Specjalistyczny w Prabutach Spolka z ograniczona odpowiedzialnoscia, Oddzial pulmonologii
Prabuty, 82-550
Anna Lowczak
Spain5 sites, 5 recruiting
- Not yet recruiting
Complejo Hospitalario Universitario A Coruna (CHUAC) - Hospital Teresa Herrera
A Coruña, 15006
Maria Rosario Garcia-Campelo
- Not yet recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Margarita Majem Tarruella
- Not yet recruiting
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, 35016
Delvys Rodríguez-Abreu
- Not yet recruiting
Hospital Clinico San Carlos
Madrid, 28040
Carlos Aguado de la Rosa
- Not yet recruiting
Centro de Investigación Oncológica Clara Campal
Madrid, 28050
Gema Garcia Ledo
Greece4 sites, 4 recruiting
- Not yet recruiting
Henry Dunant Hospital Center
Athens, 11526
Giannis Mountzios
- Not yet recruiting
Theageneio Anticancer Hospital
Thessaloniki, 54639
Dora Tsiouda
- Not yet recruiting
St Luke's Hospital
Thessaloniki, 55236
Elena Fountzila
- Not yet recruiting
European Interbalkan Medical Center
Thessaloniki, 57001
Ippokratis Korantzis
Hungary4 sites, 4 recruiting
- Not yet recruiting
Semmelweis University Department of Pulmonology
Budapest, 1083
Veronika Müller
- Not yet recruiting
Mátrai Gyógyintézet
Gyöngyös, 7151
István Albert
- Not yet recruiting
Bács-Kiskun Vármegyei Oktatókórház, Oncoradiology Center
Kecskemét, 6000
Judit Kocsis
- Not yet recruiting
Református Pulmonológiai Intézet
Törökbálint, 2045
Gabriella Gálffy
Serbia4 sites, 4 recruiting
- Not yet recruiting
University Clinical Centre of Serbia, Clinic for pulmonology
Belgrade, 11000
Natalija Samardzic
- Not yet recruiting
University Hospital Medical Center Bezanijska Kosa
Belgrade, 11000
Zoran Andric
- Not yet recruiting
University Clinical Center Kragujevac
Kragujevac, 34000
Jasmina Nedovic
- Not yet recruiting
Institute for pulmonary diseases of Vojvodina
Novi Sad, 21208
Goran Stojanovic
Australia3 sites, 3 recruiting
- Not yet recruiting
Flinders Medical Centre
Bedford Park, South Australia, 5042
Chris Karapetis
- Not yet recruiting
Canberra Hospital
Garran, Australian Capital Territory, 2605
Geoffrey Peters
- Not yet recruiting
Tasman Oncology
Southport, Queensland, 4215
Kenneth O'Byrne
Czechia3 sites, 3 recruiting
- Not yet recruiting
Nemocnice České Budějovice, a.s.
České Budějovice, 370 01
Taťána Karpianusová
- Not yet recruiting
Nemocnice Agel Vítkovice
Ostrava, 703 00
Jaromír Roubec
- Not yet recruiting
Fakultní nemocnice Ostrava (FN Ostrava)
Ostrava-Poruba, 708 52
Radoslava Černeková
Germany3 sites, 3 recruiting
- Not yet recruiting
Lungenklinik/Lungenkrebszentrum Köln-Merheim
Cologne, 51109
Birgit Saers
- Not yet recruiting
KEM | Evangelische Kliniken Essen Mitte gGmbH
Essen, 45136
Julia Galuba
- Not yet recruiting
Krankenhaus Martha-Maria Halle-Dölau
Halle, 06120
Habil. Miriam Möller
Canada2 sites, 2 recruiting
- Not yet recruiting
Arthur Child Cancer Centre
Calgary, Alberta, T2N 5G2
Vishal Navani
- Not yet recruiting
University of Sherbrooke
Greenfield Park, Quebec, J4V 2H1
Francois Panet
About this study
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
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).
Read the 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.
- Conditions
- Small Cell Lung Cancer Extensive Stage, Small-cell Lung Cancer, Small Cell Carcinoma, Sclc, SCLC,Extensive Stage, Lung Cancer
- Being tested
- BL-M14D1 and Atezolizumab, Carboplatin+ Etoposide + Atezolizumab followed by Atezolizumab and Lurbinectedin
- Keywords
- DLL3, First Line
- Medical subject headings
- Small Cell Lung Carcinoma, Carcinoma, Small Cell, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BL-M14D1 and AtezolizumabDrug
Also called BL-M14D1, 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 LurbinectedinDrug
Also called Etoposide, Atezolizumab, Lurbinectedin, Carboplatin
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | BL-M14D1: Administered on days 1 of every 21 days Atezolizumab: Administered dose on days 1 of every 21 days Receives: Drug: BL-M14D1 and Atezolizumab |
| Arm B | Experimental | BL-M14D1: Administered on days 1 of every 21 days Atezolizumab: Administered dose on days 1 of every 21 days Receives: Drug: BL-M14D1 and Atezolizumab |
| Arm C | Active comparator | Medications used in the Control Arm should be administered per local label or institutional guidelines.
Induction therapy (4 cycles):
Carboplatin (AUC of 5 mg/mL*min IV) on Day 1 of each 21-day cycle Etoposide (100 mg/m2 IV) on Days 1 through 3 of each 21-day cycle Atezolizumab (1200 mg) IV on Day 1 of each 21-day cycle
Maintenance therapy (continues until discontinuation criteria are met):
Atezolizumab (1200 mg) IV on Day 1 of each 21-day cycle Lurbinectedin (3.2 mg/m2) IV on Day 1 of each 21-day cycle (to be added only if approved in region and as per PI discretion) Receives: Drug: Carboplatin+ Etoposide + Atezolizumab followed by Atezolizumab and Lurbinectedin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR)
Progression-free survival (PFS) is defined as the time from randomization to the first documented disease progression, as assessed by blinded independent central review (BICR) according to RECIST v1.1, or death from any cause, whichever occurs first.
Measured: Up to approximately 2 years
Secondary outcomes (11)
Overall Survival (OS)
Overall survival (OS) is defined as the time from randomization to death from any cause.
Measured: Up to approximately 2 years
Participants with Serious Adverse Events (SAEs)
Measuring the number of participants with serious adverse events (SAEs)
Measured: Up to approximately 5 years
Participants with treatment-emergent adverse events (TEAEs)
Measuring the number of participants with Treatment-emergent adverse events (TEAEs) leading to discontinuation
Measured: Up to approximately 5 years
Evaluate the safety of BL-M14D1 in combination with atezolizumab
Death
Measured: Up to approximately 5 years
Participants with abnormal lab results
Measure number of participants with abnormal laboratory results
Measured: Up to approximately 5 years
To compare and quantify the impact of BL-M14D1 in combination with atezolizumab on participants' quality of life and functional status
Participant Reported Outcome (PRO) using 2 European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ)
Measured: Up to 5 years
Overall Response Rate (ORR)
To assess the clinical efficacy of BL-M14D1 as measured by ORR using RECIST criteria v 1.1 per BICR and investigator
Measured: Up to 5 years
Disease Control Rate (DCR)
To assess the clinical efficacy of BL-M14D1 as measured by DCR using RECIST criteria v 1.1 per BICR and investigator
Measured: Up to 5 years
Duration Of Response (DOR)
To assess the clinical efficacy of BL-M14D1 as measured by DOR using RECIST criteria v 1.1 per BICR and investigator or death from any cause, whichever occur first
Measured: Up to 5 years
Time To Response (TTR)
To assess the clinical efficacy of BL-M14D1 as measured by TTR using RECIST criteria v 1.1 per BICR and investigator
Measured: Up to 5 years
Progression Free Survival (PFS)
To assess the clinical efficacy of BL-M14D1 as measured by PFS using RECIST criteria v 1.1 by investigator or death from any cause, whichever occurs first
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start4 Aug 2026
- Primary completionJan 2030 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung Cancer Extensive StageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SystImmune Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Junliang Cai, MD, Study director, SystImmune Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625644
- Sponsor's protocol ID
- BL-M14D1-LC-301
- Status last verified
- Oct 2026
- First submitted
- 21 May 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No