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

ConditionsSmall Cell Lung Cancer Extensive StageSmall-cell Lung CancerSmall Cell CarcinomaSclcSCLC,Extensive StageLung CancerLung Cancer MetastaticLung Cancer Stage IV
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSystImmune Inc.

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • BL-M14D1 and Atezolizumab

    Drug

    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

    Drug

    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.

Treatment groups

550 Participants
are divided into 3 treatment groups
Group A: Arm AExperimental treatment 1 intervention
Group B: Arm BExperimental treatment 1 intervention
Group C: Arm CActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR)

Progression-free survival (PFS) is defined as the time from randomization to the first documented disease progression, as assessed by blinded independent central review (BICR) according to RECIST v1.1, or death from any cause, whichever occurs first.

Time frame
Up to approximately 2 years

Secondary outcomes

1

Overall Survival (OS)

Overall survival (OS) is defined as the time from randomization to death from any cause.

Time frame
Up to approximately 2 years
2

Participants with Serious Adverse Events (SAEs)

Measuring the number of participants with serious adverse events (SAEs)

Time frame
Up to approximately 5 years
3

Participants with treatment-emergent adverse events (TEAEs)

Measuring the number of participants with Treatment-emergent adverse events (TEAEs) leading to discontinuation

Time frame
Up to approximately 5 years
4

Evaluate the safety of BL-M14D1 in combination with atezolizumab

Death

Time frame
Up to approximately 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SystImmune Inc.

Lead sponsor

Source ClinicalTrials.gov
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