Clinical trial · Interventional
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
NCT07625644CI-TRIAL-00118229recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer Metastatic | — | UNRESOLVED | — |
| Lung Cancer Stage IV | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
| Sclc | Lung Small Cell Carcinoma | ALIAS | 0.90 |
| SCLC,Extensive Stage | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Small Cell Carcinoma | Small Cell Neuroendocrine Carcinoma | ALIAS | 0.90 |
| Small-cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
| Small Cell Lung Cancer Extensive Stage | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BL-M14D1 and Atezolizumab | Drug | — | UNRESOLVED |
| Carboplatin+ Etoposide + Atezolizumab followed by Atezolizumab and Lurbinectedin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- BL-M14D1: Administered on days 1 of every 21 days Atezolizumab: Administered dose on days 1 of every 21 days
- interventionNames
- Drug: BL-M14D1 and Atezolizumab
- type
- EXPERIMENTAL
- label
- Arm B
- description
- BL-M14D1: Administered on days 1 of every 21 days Atezolizumab: Administered dose on days 1 of every 21 days
- interventionNames
- Drug: BL-M14D1 and Atezolizumab
- type
- ACTIVE_COMPARATOR
- label
- Arm C
- description
- Medications used in the Control Arm should be administered per local label or institutional guidelines. Induction therapy (4 cycles): Carboplatin (AUC of 5 mg/mL\*min IV) on Day 1 of each 21-day cycle Etoposide (100 mg/m2 IV) on Days 1 through 3 of each 21-day cycle Atezolizumab (1200 mg) IV on Day 1 of each 21-day cycle Maintenance therapy (continues until discontinuation criteria are met): Atezolizumab (1200 mg) IV on Day 1 of each 21-day cycle Lurbinectedin (3.2 mg/m2) IV on Day 1 of each 21-day cycle (to be added only if approved in region and as per PI discretion)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.