BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer (BrenDeLL-Lung01)
Sponsor: SystImmune Inc.
ClinicalTrials ID:NCT07625644
This Phase 3, open-label, multicenter study assesses the efficacy and safety of BL-M14D1 with atezolizumab versus standard therapy in untreated ES-SCLC adults. Eligible participants must have confirmed ES-SCLC, be suitable for platinum-based chemotherapy with anti-PD-L1, and meet specific health criteria. Interventions include BL-M14D1 with atezolizumab or carboplatin, etoposide, and atezolizumab.
Patient Parameters
| Parameter | Options |
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Program Overview
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).
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.
Eligibility Criteria
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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Highlands Oncology Group | 72762 | Springdale | Arkansas |
| Los Alamitos Hematology/Oncology Medical Group | 91203 | Glendale | California |
| MemorialCare Todd Cancer Institute | 90806 | Long Beach | California |
| Valkyrie Clinical Trials | 90067 | Los Angeles | California |
| Total Health and Research Center | 33176 | Miami | Florida |
| Astera Cancer Care | 08816 | East Brunswick | New Jersey |
| Virginia Cancer Specialists | 22031 | Fairfax | Virginia |
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