BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer (BrenDeLL-Lung01)
Starting soon · Phase 3
Conditions studied: Small Cell Lung Cancer Extensive Stage, Small-cell Lung Cancer, Small Cell Carcinoma, Sclc, SCLC,Extensive Stage, Lung Cancer, Lung Cancer Metastatic, Lung Cancer Stage IV
In brief
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).
Key facts
- Study ID
- NCT07625644
- Run by
- SystImmune Inc.
- People needed
- 550
- Starts
- 2026-06-01
- Expected to finish
- 2031-06-01
- Last updated by the study team
- 2026-07-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Full record on ClinicalTrials.gov
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