550 Participants NeededMy employer runs this trial

BL-M14D1 + Atezolizumab for Small Cell Lung Cancer

Recruiting at 61 trial locations
BM
LV
Overseen ByLoren VanPelt
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: SystImmune Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Who Is on the Research Team?

JC

Junliang Cai, MD

Principal Investigator

SystImmune Inc.

Are You a Good Fit for This Trial?

This trial is for adults with newly diagnosed extensive-stage small cell lung cancer who have not received prior treatment. Participants must be healthy enough for chemo and immunotherapy, have at least one tumor that can be measured, good organ function, and be able to carry out daily activities.

Inclusion Criteria

At least one measurable lesion based on RECIST v1.1 per investigator assessment
I am able to receive platinum chemotherapy with an anti-PD-L1 drug.
I am fully active or restricted in physically strenuous activity only.
See 2 more

Exclusion Criteria

Other protocol-defined inclusion/exclusion criteria apply
I have received platinum or etoposide treatment for limited stage SCLC in the past 6 months.
I have received topoisomerase inhibitor-based ADC therapy before.
See 3 more

What Are the Treatments Tested in This Trial?

Interventions

  • Atezolizumab
  • BL-M14D1

Trial Overview

The study compares a new drug combo (BL-M14D1 plus Atezolizumab) against the standard treatment (Carboplatin, Etoposide, and Atezolizumab followed by Atezolizumab and Lurbinectedin). Patients are randomly assigned to either group.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: Arm BExperimental Treatment1 Intervention
Group II: Arm AExperimental Treatment1 Intervention
Group III: Arm CActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

SystImmune Inc.

Lead Sponsor

Trials
23
Recruited
1,800+