Lung Cancer, Lung Cancer Metastatic, Lung Cancer Stage IV, Sclc, SCLC,Extensive Stage, Small Cell Carcinoma, Small-cell Lung Cancer, Small Cell Lung Cancer Extensive Stage
Conditions
Keywords
DLL3, First Line
Brief summary
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).
Detailed 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.
Interventions
DRUGBL-M14D1 and Atezolizumab
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.
DRUGCarboplatin+ Etoposide + Atezolizumab followed by Atezolizumab and Lurbinectedin
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.
Sponsors
SystImmune Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Blinded Independent Central Review (BICR)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR) | Up to approximately 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Up to approximately 2 years | Overall survival (OS) is defined as the time from randomization to death from any cause. |
| Participants with Serious Adverse Events (SAEs) | Up to approximately 5 years | Measuring the number of participants with serious adverse events (SAEs) |
| Participants with treatment-emergent adverse events (TEAEs) | Up to approximately 5 years | Measuring the number of participants with Treatment-emergent adverse events (TEAEs) leading to discontinuation |
| Evaluate the safety of BL-M14D1 in combination with atezolizumab | Up to approximately 5 years | Death |
| Participants with abnormal lab results | Up to approximately 5 years | Measure number of participants with abnormal laboratory results |
| To compare and quantify the impact of BL-M14D1 in combination with atezolizumab on participants' quality of life and functional status | Up to 5 years | Participant Reported Outcome (PRO) using 2 European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ) |
| Overall Response Rate (ORR) | Up to 5 years | To assess the clinical efficacy of BL-M14D1 as measured by ORR using RECIST criteria v 1.1 per BICR and investigator |
| Disease Control Rate (DCR) | Up to 5 years | To assess the clinical efficacy of BL-M14D1 as measured by DCR using RECIST criteria v 1.1 per BICR and investigator |
| Duration Of Response (DOR) | Up to 5 years | 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 |
| Time To Response (TTR) | Up to 5 years | To assess the clinical efficacy of BL-M14D1 as measured by TTR using RECIST criteria v 1.1 per BICR and investigator |
| Progression Free Survival (PFS) | Up to 5 years | 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 |
Countries
Australia, Bulgaria, Canada, Czechia, France, Georgia, Germany, Greece, Hungary, Italy, Poland, Serbia, Spain, United States
Contacts
CONTACTLoren VanPelt
STUDY_DIRECTORJunliang Cai, MD
SystImmune Inc.
Outcome results
None listed