About 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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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,

Trial design

Treatments tested in this trial

  • BL-M14D1 and Atezolizumab
  • Carboplatin+ Etoposide + Atezolizumab followed by Atezolizumab and Lurbinectedin

Treatment groups

550 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

SystImmune Inc.

Lead sponsor