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

Systimmune

Status and phase: Not yet enrolling; Phase 3

Conditions: Lung Cancer Metastatic; Lung Cancer Stage IV; Small-cell Lung Cancer; Small Cell Carcinoma; Lung Cancer; SCLC,Extensive Stage; Small Cell Lung Cancer Extensive Stage; Sclc

Treatments: Drug: BL-M14D1 and Atezolizumab; Drug: Carboplatin+ Etoposide + Atezolizumab followed by Atezolizumab and Lurbinectedin

Study type: Interventional

Funder types: Industry

Identifiers

NCT07625644

BL-M14D1-LC-301

Details and patient eligibility

About

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).

Full description

This study is a Global Phase 3, open-label, multicenter study designed to evaluate the efficacy and safety of BL-M14D1 in combination with atezolizumab compared with standard-of-care therapy in adult participants with previously untreated extensive-stage small cell lung cancer (ES-SCLC). Standard-of-care therapy consists of carboplatin plus etoposide chemotherapy and atezolizumab, followed by maintenance treatment with atezolizumab with or without lurbinectedin.

Enrollment: 550 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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550 participants in 3 patient groups

Arm A

Experimental group

Description:

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

Treatment:

Drug: BL-M14D1 and Atezolizumab

Arm B

Experimental group

Description:

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

Treatment:

Drug: BL-M14D1 and Atezolizumab

Arm C

Active Comparator group

Description:

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)

Treatment:

Drug: Carboplatin+ Etoposide + Atezolizumab followed by Atezolizumab and Lurbinectedin