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NOT YET RECRUITING
NCT07625644
PHASE3

Evaluate BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer

Sponsor: SystImmune Inc.

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

550

Start Date

2026-06

Completion Date

2031-06

Last Updated

2026-06-04

Healthy Volunteers

No

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.