BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer (BrenDeLL-Lung01)
Recruiting · NCT07625644 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
BL-M14D1 and AtezolizumabCarboplatin+ Etoposide + Atezolizumab followed by Atezolizumab and Lurbinectedin
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 5 US states.
- Highlands Oncology Group - Springdale, Arkansas, United States
- Los Alamitos Hematology/Oncology Medical Group - Glendale, California, United States
- MemorialCare Todd Cancer Institute - Long Beach, California, United States
- Valkyrie Clinical Trials - Los Angeles, California, United States
- Total Health and Research Center - Miami, Florida, United States
- Astera Cancer Care - East Brunswick, New Jersey, United States
- Virginia Cancer Specialists - Fairfax, Virginia, United States
- Complejo Hospitalario Universitario A Coruna (CHUAC) - Hospital Teresa Herrera - A Coruña, Spain
- Henry Dunant Hospital Center - Athens, Greece
- Centro di Riferimento Oncologico - Aviano, Italy
- Hospital de la Santa Creu i Sant Pau - Barcelona, Spain
- University Clinical Centre of Serbia, Clinic for pulmonology - Belgrade, Serbia
- University Hospital Medical Center Bezanijska Kosa - Belgrade, Serbia
- Uniwersytecki Szpital Kliniczny w Bialymstoku, II Klinika Chorob Pluc, Raka Pluca i Chorob Wewnetrznych - Bialystok, Poland
- Semmelweis University Department of Pulmonology - Budapest, Hungary
- Lungenklinik/Lungenkrebszentrum Köln-Merheim - Cologne, Germany
- Organization Centre Hospitalier Intercommunal de Creteil (CHIC) - Centre de Recherche Clinique (CRC) (Clinical Research Center) - Créteil, France
- KEM | Evangelische Kliniken Essen Mitte gGmbH - Essen, Germany
- MHAT Dr. Tota Venkova - Gabrovo, Bulgaria
- Szpitale Pomorskie Spolka z ograniczona odpowiedzialnoscia, Oddzial Onkologii i Radioterapii - Dzial Onkologii Klinicznej - Gdynia, Poland
- Mátrai Gyógyintézet - Gyöngyös, Hungary
- Krankenhaus Martha-Maria Halle-Dölau - Halle, Germany
- Oddzial Onkologii Klinicznej - Katowice, Poland
- Bács-Kiskun Vármegyei Oktatókórház, Oncoradiology Center - Kecskemét, Hungary
- University Clinical Center Kragujevac - Kragujevac, Serbia
- Hospital Universitario Insular de Gran Canaria - Las Palmas de Gran Canaria, Spain
- Instytut "Centrum Zdrowia Matki Polki", Klinika Onkologii - Lodz, Poland
- CLB - Centre Léon Bérard - Lyon, France
- Hospital Clinico San Carlos - Madrid, Spain
- Centro de Investigación Oncológica Clara Campal - Madrid, Spain
- IPC - lnstitut Paoli-Calmettes - Marseille, France
- Institute for pulmonary diseases of Vojvodina - Novi Sad, Serbia
- Nemocnice Agel Vítkovice - Ostrava, Czechia
- Fakultní nemocnice Ostrava (FN Ostrava) - Ostrava-Poruba, Czechia
- Policlinico Paolo Giaccone University Hospital - Palermo, Italy
- Universite Pierre et Marie Curie (UPMC) - Center de Recherche des Cordeliers (CRC) - Paris, France
- MHAT Heart and Brain - Pleven, Bulgaria
- Medical Centre FutureMeds - Plovdiv, Bulgaria
- MHAT Pulmed - Plovdiv, Bulgaria
- Szpital Specjalistyczny w Prabutach Spolka z ograniczona odpowiedzialnoscia, Oddzial pulmonologii - Prabuty, Poland
- Regina Elena Institute for Cancer Research - Roma, Italy
- Fondazione Policlinico Universitario A. Gemelli IRCCS - Roma, Italy
- ICO - L'Institut de Cancérologie de L'Ouest - Saint-Herblain, France
- AOUS Le Scotte, UOC Immunoterapia Oncologica - Siena, Italy
- UMHAT Sveti Ivan Rilski - Sofia, Bulgaria
- MHAT Serdikamed - Sofia, Bulgaria
- LTD High Technology Hospital Medcenter - Tbilisi, Georgia
- Ltd New Hospitals - Tbilisi, Georgia
- Pineo Medical Ecosystem LtD - Tbilisi, Georgia
- LLC Todua Clinic - Tbilisi, Georgia
- The First Medical Clinic LLC - Tbilisi, Georgia
- Caucasus Medical Centre - Tbilisi, Georgia
- Theageneio Anticancer Hospital - Thessaloniki, Greece
- St Luke's Hospital - Thessaloniki, Greece
- European Interbalkan Medical Center - Thessaloniki, Greece
- Református Pulmonológiai Intézet - Törökbálint, Hungary
- Nemocnice České Budějovice, a.s. - České Budějovice, Czechia
- Arthur Child Cancer Centre - Calgary, Alberta, Canada
- Canberra Hospital - Garran, Australian Capital Territory, Australia
- University of Sherbrooke - Greenfield Park, Quebec, Canada
Showing 60 of 62 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →