BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Canc… (NCT07625644) | Clinical Trial Compass
Not Yet RecruitingPhase 3
BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer (BrenDeLL-Lung01)
550 participantsStarted 2026-06
Plain-language summary
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 participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a new drug combination called BL-M14D1 plus atezolizumab against the current standard of care for extensive-stage small cell lung cancer — can you explain what the standard of care looks like right now, and how this experimental combination is different from what I'd receive outside a trial?
2Since this is a Phase 3 trial, there's already some earlier-phase safety data on BL-M14D1 — what do you know about the side effect profile of this drug, and are there any risks that concern you given my specific health situation?
3The trial is listed as 'not yet recruiting,' which means it isn't open yet — do you have any sense of when it might open, where the nearest participating sites might be, and whether waiting for it could affect my treatment options in the meantime?
4The main thing this trial is measuring is progression-free survival, meaning how long patients go without the cancer getting worse — is that the most important outcome for my situation, or are there other things like overall survival or quality of life that I should be weighing when comparing this trial to starting standard treatment now?
5Because this is a randomized trial comparing two groups, there's a chance I could be assigned to the standard-of-care arm rather than the new combination — would I still have access to this experimental drug if the trial ends or if I'm not assigned to that group?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR)