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

NCT07625644 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 550

Last updated 2026-07-16

No results posted yet for this study

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).

Conditions

  • Small Cell Lung Cancer Extensive Stage
  • Small-cell Lung Cancer
  • Small Cell Carcinoma
  • Sclc
  • SCLC,Extensive Stage
  • Lung Cancer
  • Lung Cancer Metastatic
  • Lung Cancer Stage IV

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.

Sponsors & Collaborators

  • SystImmune Inc.

    lead INDUSTRY

Principal Investigators

  • Rishi Jain, MD · SystImmune Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2030-01-31
Completion
2031-06-30
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07625644 on ClinicalTrials.gov