Recruiting
Phase 3

BL-M14D1 & Atezolizumab

Sponsor:

SystImmune Inc.

Code:

NCT07625644

Conditions

Small Cell Lung Cancer Extensive Stage

Small-cell Lung Cancer

Small Cell Carcinoma

Sclc

SCLC,Extensive Stage

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BL-M14D1 and Atezolizumab

Carboplatin+ Etoposide + Atezolizumab followed by Atezolizumab and Lurbinectedin

Study Details

Brief 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

Study ID

NCT07625644

Start date

Aug 4, 2026

Status verified date

Sep, 2026

Completion date

Jun, 2031

Anticipated

Primary completion date

Jan, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

550 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A

BL-M14D1: Administered on days 1 of every 21 days Atezolizumab: Administered dose on days 1 of every 21 days

experimental: Arm B

BL-M14D1: Administered on days 1 of every 21 days Atezolizumab: Administered dose on days 1 of every 21 days

active comparator: Arm C

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)

Interventions

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.

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 measure

  • Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR) [ Time Frame: Up to approximately 2 years ]

Central Contacts and Locations

Central contacts

Loren VanPelt

425-453-6841loren.vanpelt@systimmune.com

Locations

Los Alamitos Hematology/Oncology Medical Group

Recruiting

Glendale, California, United States, 91203

Principal Investigator:

Michael Nguyen

MemorialCare Todd Cancer Institute

Recruiting

Long Beach, California, United States, 90806

Principal Investigator:

Nilesh Vora

Valkyrie Clinical Trials

Recruiting

Los Angeles, California, United States, 90067

Contacts

Trenis Palmer

912-398-3205trenis.palmer@vctcare.com

Principal Investigator:

David Berz

Astera Cancer Care

Recruiting

East Brunswick, New Jersey, United States, 08816

Principal Investigator:

Neel Belani

Virginia Cancer Specialists

Recruiting

Fairfax, Virginia, United States, 22031

Principal Investigator:

Alexander Spira

More Information

Sponsor

SystImmune Inc.

Last update posted

Sep 15, 2026

Last verified

Sep, 2026

Keywords

  • DLL3
  • First Line

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-16. This information was provided to ClinicalTrials.gov by SystImmune Inc. on 2026-09-15.