NCT07625644RecruitingPhase 3
BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer (BrenDeLL-Lung01)
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
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 550 (estimated)
- First submitted
- 21 May 2026
- Start date
- 4 Aug 2026
- Primary completion date
- Jan 2030
- Lead sponsor
- SystImmune Inc.
- Diseases
- Lung cancer
- NCT number
- NCT07625644
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 550
- From 4 Aug 2026 to the primary completion date, Jan 2030
- 62 sites in 14 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 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 illness
- Participants with history of severe heart disease
- Participants with active autoimmune diseases and inflammatory diseases,
Other
- Other protocol-defined inclusion/exclusion criteria apply.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (62)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Flinders Medical Centre Coordinator of this site? Confirm its status | Bedford Park | Australia | Not yet recruiting |
| Canberra Hospital Coordinator of this site? Confirm its status | Garran | Australia | Not yet recruiting |
| Tasman Oncology Coordinator of this site? Confirm its status | Southport | Australia | Not yet recruiting |
| MHAT Dr. Tota Venkova Coordinator of this site? Confirm its status | Gabrovo | Bulgaria | Not yet recruiting |
| MHAT Heart and brain Coordinator of this site? Confirm its status | Pleven | Bulgaria | Not yet recruiting |
| MHAT Pulmed Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Not yet recruiting |
| Medical Centre FutureMeds Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Not yet recruiting |
| UMHAT Sveti Ivan Rilski Coordinator of this site? Confirm its status | Sofia | Bulgaria | Not yet recruiting |
| MHAT Serdikamed Coordinator of this site? Confirm its status | Sofia | Bulgaria | Not yet recruiting |
| Arthur Child Cancer Centre Coordinator of this site? Confirm its status | Calgary | Canada | Not yet recruiting |
| University of Sherbrooke Coordinator of this site? Confirm its status | Greenfield Park | Canada | Not yet recruiting |
| Nemocnice České Budějovice, a.s. Coordinator of this site? Confirm its status | České Budějovice | Czechia | Not yet recruiting |
| Nemocnice Agel Vítkovice Coordinator of this site? Confirm its status | Ostrava | Czechia | Not yet recruiting |
| Fakultní nemocnice Ostrava (FN Ostrava) Coordinator of this site? Confirm its status | Ostrava-Poruba | Czechia | Not yet recruiting |
| Lungenklinik/Lungenkrebszentrum Köln-Merheim Coordinator of this site? Confirm its status | Cologne | Germany | Not yet recruiting |
| KEM | Evangelische Kliniken Essen Mitte gGmbH Coordinator of this site? Confirm its status | Essen | Germany | Not yet recruiting |
| Krankenhaus Martha-Maria Halle-Dolau Coordinator of this site? Confirm its status | Halle | Germany | Not yet recruiting |
| Complejo Hospitalario Universitario A Coruna (CHUAC) - Hospital Teresa Herrera Coordinator of this site? Confirm its status | A Coruña | Spain | Not yet recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Hospital Universitario Insular de Gran Canaria Coordinator of this site? Confirm its status | Las Palmas de Gran Canaria | Spain | Not yet recruiting |
| Centro de Investigación Oncológica Clara Campal Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Organization Centre Hospitalier Intercommunal de Creteil (CHIC) - Centre de Recherche Clinique (CRC) (Clinical Research Center) Coordinator of this site? Confirm its status | Créteil | France | Not yet recruiting |
| CLB - Centre Léon Bérard Coordinator of this site? Confirm its status | Lyon | France | Not yet recruiting |
| IPC - lnstitut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Not yet recruiting |
| Universite Pierre et Marie Curie (UPMC) - Center de Recherche des Cordeliers (CRC) Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| ICO - L'Institut de Cancérologie de L'Ouest Coordinator of this site? Confirm its status | Saint-Herblain | France | Not yet recruiting |
| Caucasus Medical Centre Coordinator of this site? Confirm its status | Tbilisi | Georgia | Not yet recruiting |
| LTD "New Hospitals" Coordinator of this site? Confirm its status | Tbilisi | Georgia | Not yet recruiting |
| The First Medical Clinic LLC Coordinator of this site? Confirm its status | Tbilisi | Georgia | Not yet recruiting |
| Pineo Medical Ecosystem LtD Coordinator of this site? Confirm its status | Tbilisi | Georgia | Not yet recruiting |
| LTD High Technology Hospital Medcenter Coordinator of this site? Confirm its status | Tbilisi | Georgia | Not yet recruiting |
| Llc Todua Clinic Coordinator of this site? Confirm its status | Tbilisi | Georgia | Not yet recruiting |
| Henry Dunant Hospital Center Coordinator of this site? Confirm its status | Athens | Greece | Not yet recruiting |
| Theageneio Anticancer Hospital Coordinator of this site? Confirm its status | Thessaloniki | Greece | Not yet recruiting |
| European Interbalkan Medical Center Coordinator of this site? Confirm its status | Thessaloniki | Greece | Not yet recruiting |
| St. Luke's Hospital Coordinator of this site? Confirm its status | Thessaloniki | Greece | Not yet recruiting |
| Semmelweis University Department of Pulmonology Coordinator of this site? Confirm its status | Budapest | Hungary | Not yet recruiting |
| Matrai Gyogyintezet Coordinator of this site? Confirm its status | Gyöngyös | Hungary | Not yet recruiting |
| Bács-Kiskun Vármegyei Oktatókórház, Oncoradiology Center Coordinator of this site? Confirm its status | Kecskemét | Hungary | Not yet recruiting |
| Református Pulmonológiai Intézet Coordinator of this site? Confirm its status | Törökbálint | Hungary | Not yet recruiting |
| Centro di Riferimento Oncologico Coordinator of this site? Confirm its status | Aviano | Italy | Not yet recruiting |
| Policlinico Paolo Giaccone University Hospital Coordinator of this site? Confirm its status | Palermo | Italy | Not yet recruiting |
| Regina Elena Institute for Cancer Research Coordinator of this site? Confirm its status | Roma | Italy | Not yet recruiting |
| Fondazione Policlinico Universitario A. Gemelli IRCCS Coordinator of this site? Confirm its status | Roma | Italy | Not yet recruiting |
| AOUS Le Scotte, UOC Immunoterapia Oncologica Coordinator of this site? Confirm its status | Siena | Italy | Not yet recruiting |
| Uniwersytecki Szpital Kliniczny w Bialymstoku, II Klinika Chorob Pluc, Raka Pluca i Chorob Wewnetrznych Coordinator of this site? Confirm its status | Bialystok | Poland | Not yet recruiting |
| Szpitale Pomorskie Spolka z ograniczona odpowiedzialnoscia, Oddzial Onkologii i Radioterapii - Dzial Onkologii Klinicznej Coordinator of this site? Confirm its status | Gdynia | Poland | Not yet recruiting |
| Oddzial Onkologii Klinicznej Coordinator of this site? Confirm its status | Katowice | Poland | Not yet recruiting |
| Instytut "Centrum Zdrowia Matki Polki", Klinika Onkologii Coordinator of this site? Confirm its status | Lodz | Poland | Not yet recruiting |
| Szpital Specjalistyczny w Prabutach Spolka z ograniczona odpowiedzialnoscia, Oddzial pulmonologii Coordinator of this site? Confirm its status | Prabuty | Poland | Not yet recruiting |
| University Hospital Medical Center Bezanijska Kosa Coordinator of this site? Confirm its status | Belgrade | Serbia | Not yet recruiting |
| University Clinical Centre of Serbia, Clinic for pulmonology Coordinator of this site? Confirm its status | Belgrade | Serbia | Not yet recruiting |
| University Clinical Center Kragujevac Coordinator of this site? Confirm its status | Kragujevac | Serbia | Not yet recruiting |
| Institute for pulmonary diseases of Vojvodina Coordinator of this site? Confirm its status | Novi Sad | Serbia | Not yet recruiting |
| Astera Cancer Care Coordinator of this site? Confirm its status | East Brunswick | United States | Recruiting |
| Virginia Cancer Specialists Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| OPN Healthcare Coordinator of this site? Confirm its status | Glendale | United States | Recruiting |
| MemorialCare Todd Cancer Institute Coordinator of this site? Confirm its status | Long Beach | United States | Recruiting |
| Valkyrie Clinical Trials Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Total Health and Research Center Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Highlands Oncology Group Coordinator of this site? Confirm its status | Springdale | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.