NCT07625644 · SystImmune Inc.
BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer (BrenDeLL-Lung01)
What this study is about
The objective of the study is to evaluate the effectiveness 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).
View original scientific 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).
Interventions
DRUG
BL-M14D1 and Atezolizumab
BL-M14D1 administered in combination with atezolizumab. BL-M14D1 will be given intravenously at the protocol-specified dose and schedule. Atezolizumab will be administered intravenously according to the approved dosing regimen.
DRUG
Carboplatin+ Etoposide + Atezolizumab followed by Atezolizumab and Lurbinectedin
Carboplatin and etoposide will be administered intravenously in combination with atezolizumab for induction therapy, followed by maintenance treatment with atezolizumab with or without lurbinectedin per protocol.
Primary outcome measures
Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR)
Time frame: Up to approximately 2 years
Progression-free survival (PFS) is defined as the time from randomization to the first documented disease progression, as assessed by blinded independent central review (BICR) according to RECIST v1.1, or death from any cause, whichever occurs first.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Springdale, Arkansas
- Glendale, California
- Long Beach, California
- Los Angeles, California
- Miami, Florida
- East Brunswick, New Jersey
- Fairfax, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 15, 2026 · Source of record for eligibility and locations