A Phase 3 interventional study of BL-M14D1 and Atezolizumab and Carboplatin+ Etoposide + Atezolizumab followed by Atezolizumab and Lurbinectedin in Small Cell Lung Cancer Extensive Stage, Small-cell Lung Cancer and Small Cell Carcinoma, sponsored by SystImmune Inc.. Recruiting at 62 sites in 14 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by SystImmune Inc. (part of Sichuan Biokin Pharmaceutical Co., Ltd.) · Phase 3, Interventional, and Treatment
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.
1,301 studies on the registry are indexed under Small Cell Lung Carcinoma; 367 are open to participants now.
This study's planned enrollment of 550 is above the median of 56 across 1,077 interventional studies indexed under Small Cell Lung Carcinoma.
Browse Small Cell Lung Carcinoma studies →SystImmune Inc. is the lead sponsor of 9 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BL-M14D1: Administered on days 1 of every 21 days Atezolizumab: Administered dose on days 1 of every 21 days
Drug: BL-M14D1 and Atezolizumab
BL-M14D1: Administered on days 1 of every 21 days Atezolizumab: Administered dose on days 1 of every 21 days
Drug: BL-M14D1 and Atezolizumab
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)
Drug: Carboplatin+ Etoposide + Atezolizumab followed by Atezolizumab and Lurbinectedin
Drug pages: Anti-DLL3 Antibody-drug Conjugate BL-M14D1 · 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.
Also known as: BL-M14D1, Atezolizumab
Drug pages: Carboplatin · Etoposide · Atezolizumab · PM 01183
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.
Also known as: Etoposide, Atezolizumab, Lurbinectedin, Carboplatin
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
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
Participants with Serious Adverse Events (SAEs)
Measuring the number of participants with serious adverse events (SAEs)
Time frame: 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
Time frame: Up to approximately 5 years
Evaluate the safety of BL-M14D1 in combination with atezolizumab
Death
Time frame: Up to approximately 5 years
Participants with abnormal lab results
Measure number of participants with abnormal laboratory results
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 5 years
Started Aug 2026 (actual). Primary completion is estimated for Jan 2030, 41 months after the start.
Of 56 industry-sponsored phase 3 interventional studies under Small Cell Lung Carcinoma, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 44. This study's planned 41 months is above that.
Counting every sponsor, half of 69 studies reached it within 44 months; a quarter within 31 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Anti-DLL3 Antibody-drug Conjugate BL-M14D1 · Atezolizumab