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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | BL-M14D1: Administered on days 1 of every 21 days Atezolizumab: Administered dose on days 1 of every 21 days |
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| Arm B | Experimental | BL-M14D1: Administered on days 1 of every 21 days Atezolizumab: Administered dose on days 1 of every 21 days |
|
| Arm C | Active Comparator | 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall survival (OS) is defined as the time from randomization to death from any cause. | Up to approximately 2 years |
| Participants with Serious Adverse Events (SAEs) | Measuring the number of participants with serious adverse events (SAEs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Beth Metzheiser | Contact | 425-453-6841 | beth.metzheiser@systimmune.com |
| Name | Affiliation | Role |
|---|---|---|
| Rishi Jain, MD | SystImmune Inc. | Study Director |
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Blinded Independent Central Review (BICR)
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| 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. |
|
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| Up to approximately 5 years |
| Participants with treatment-emergent adverse events (TEAEs) | Measuring the number of participants with Treatment-emergent adverse events (TEAEs) leading to discontinuation | Up to approximately 5 years |
| Evaluate the safety of BL-M14D1 in combination with atezolizumab | Death | Up to approximately 5 years |
| Participants with abnormal lab results | Measure number of participants with abnormal laboratory results | Up to approximately 5 years |
| To compare and quantify the impact of BL-M14D1 in combination with atezolizumab on participants' quality of life and functional status | Participant Reported Outcome (PRO) using 2 European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ) | Up to 5 years |
| Overall Response Rate (ORR) | To assess the clinical efficacy of BL-M14D1 as measured by ORR using RECIST criteria v 1.1 per BICR and investigator | Up to 5 years |
| Disease Control Rate (DCR) | To assess the clinical efficacy of BL-M14D1 as measured by DCR using RECIST criteria v 1.1 per BICR and investigator | Up to 5 years |
| Duration Of Response (DOR) | To assess the clinical efficacy of BL-M14D1 as measured by DOR using RECIST criteria v 1.1 per BICR and investigator or death from any cause, whichever occur first | Up to 5 years |
| Time To Response (TTR) | To assess the clinical efficacy of BL-M14D1 as measured by TTR using RECIST criteria v 1.1 per BICR and investigator | Up to 5 years |
| Progression Free Survival (PFS) | To assess the clinical efficacy of BL-M14D1 as measured by PFS using RECIST criteria v 1.1 by investigator or death from any cause, whichever occurs first | Up to 5 years |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| D018288 | Carcinoma, Small Cell |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| C098534 | EC regimen |
| C568606 | PM 01183 |
| D005047 | Etoposide |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D056831 | Coordination Complexes |
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