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Not yet recruiting NCT07625644

BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer (BrenDeLL-Lung01)

Phase III Interventional Small Cell Lung Cancer Extensive Stage Small-cell Lung Cancer Small Cell Carcinoma Sclc

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BL-M14D1 and Atezolizumab, Carboplatin+ Etoposide + Atezolizumab followed by Atezolizumab and Lurbinectedin.
Who it may be relevant to
Registry conditions: Small Cell Lung Cancer Extensive Stage, Small-cell Lung Cancer, Small Cell Carcinoma, Sclc. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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).

Detailed 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.

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]
Secondary outcome measures (11)
  • Overall Survival (OS) [Time frame: Up to approximately 2 years]
  • Participants with Serious Adverse Events (SAEs) [Time frame: Up to approximately 5 years]
  • Participants with treatment-emergent adverse events (TEAEs) [Time frame: Up to approximately 5 years]
  • Evaluate the safety of BL-M14D1 in combination with atezolizumab [Time frame: Up to approximately 5 years]
  • Participants with abnormal lab results [Time frame: Up to approximately 5 years]
  • To compare and quantify the impact of BL-M14D1 in combination with atezolizumab on participants' quality of life and functional status [Time frame: Up to 5 years]
  • Overall Response Rate (ORR) [Time frame: Up to 5 years]
  • Disease Control Rate (DCR) [Time frame: Up to 5 years]
  • Duration Of Response (DOR) [Time frame: Up to 5 years]
  • Time To Response (TTR) [Time frame: Up to 5 years]
  • Progression Free Survival (PFS) [Time frame: Up to 5 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07625644 · BL-M14D1-LC-301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗