Compares BL-M14D1 plus atezolizumab with standard treatment in untreated small cell lung cancer
Tests BL-M14D1 with atezolizumab in adults with untreated extensive-stage lung cancer.
Plain-language title generated from the registry record
Registry title: BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer (BrenDeLL-Lung01)
Key facts
- Where
- Budapest, Gyöngyös, Kecskemét, and Törökbálint, HungarySee the 4 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Which best describes your lung cancer?
- Has the cancer spread to other parts of the body, or is it too advanced to be removed by surgery?
Source: NCT07625644, who can take part
Where in Hungary
- Semmelweis University Department of PulmonologyBudapest, HungaryNot yet recruiting
- Matrai GyogyintezetGyöngyös, HungaryNot yet recruiting
- Bács-Kiskun Vármegyei Oktatókórház, Oncoradiology CenterKecskemét, HungaryNot yet recruiting
- Református Pulmonológiai IntézetTörökbálint, HungaryNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- SystImmune Inc.
- Trial code
- NCT07625644
- Record updated
- 15 October 2026
- Original description
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 full original descriptionShow less
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).
Inclusion: 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: 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; Participants with history of severe heart disease; Participants with active autoimmune diseases and inflammatory diseases,; Other protocol-defined inclusion/exclusion criteria apply.