BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer (BrenDeLL-Lung01)
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests BL-M14D1 plus atezolizumab against standard treatment. It looks at how well the treatment works and how safe it is in adults with small cell lung cancer that has spread widely and has not yet been treated.
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have small cell lung cancer that has spread widely, confirmed by a tissue or cell test, and are starting first treatment.
- Can receive platinum-based chemotherapy plus an anti-PD-L1 drug, which helps the immune system fight cancer.
- Have at least one cancer spot that the study doctor can measure.
- Are fully active or can do light work despite limits on hard physical activity.
- Have organs that work well enough for the study.
Who can't join
- Received platinum chemotherapy or etoposide for limited-stage small cell lung cancer within the past 6 months.
- Previously received an antibody-drug conjugate (ADC) containing a topoisomerase inhibitor—a drug linked to an antibody that targets cancer cells.
- Have a history of severe heart disease.
- Have an active autoimmune disease, where the immune system attacks the body, or an active disease that causes inflammation.
- Have another past or current cancer. Exceptions include certain skin cancers or cancers that have not spread beyond where they started and were fully removed, or another cancer treated to cure it with at least 3 years free of disease.
Simplified for readability. The official criteria below are what the study team uses.
Official 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.
Study sites (7)
AR
- Highlands Oncology Group · Springdale, AR 72762Eric Schaefer · Principal investigatorMore trials in Springdale
CA
- OPN Healthcare · Glendale, CA 91203Michael Nguyen · Principal investigatorMore trials in Glendale
- MemorialCare Todd Cancer Institute · Long Beach, CA 90806Nilesh Vora · Principal investigatorMore trials in Long Beach
- Valkyrie Clinical Trials · Los Angeles, CA 90067Trenis Palmer · Study contact · 912-398-3205 · trenis.palmer@vctcare.comDavid Berz · Principal investigatorMore trials in Los Angeles
FL
- Total Health and Research Center · Miami, FL 33176Francisco Belette · Principal investigatorMore trials in Miami
NJ
- Astera Cancer Care · East Brunswick, NJ 08816Neel Belani · Principal investigatorMore trials in East Brunswick
VA
- Virginia Cancer Specialists · Fairfax, VA 22031Alexander Spira · Principal investigatorMore trials in Fairfax