Extensive Stage Small Cell Lung Cancer
Conditions
Keywords
Extensive Stage Small Cell Lung Cancer, Anti-PD-1 Monoclonal Antibody
Brief summary
This is a randomized, open-label study of Serplulimab plus chemotherapy (Carboplatin-Etoposide) in comparison with Atezolizumab plus chemotherapy in previously untreated US patients with ES-SCLC. Subjects in this study will be randomized to arm A or B at 1:1 ratio as follows: * Arm A (Serplulimab): Serplulimab + chemotherapy (carboplatin-etoposide) * Arm B (control): Atezolizumab + chemotherapy (carboplatin-etoposide)
Interventions
DRUGSerplulimab + chemotherapy (carboplatin-etoposide)
Drug: Serplulimab is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc. Drug: carboplatin and etoposide chemotherapeutics
DRUGAtezolizumab + chemotherapy (carboplatin-etoposide)
Drug: Atezolizumab is a monoclonal antibody targeting PD-L1，developed by Roche Pharma AG. Drug: carboplatin and etoposide chemotherapeutics
Sponsors
Shanghai Henlius Biotech
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Voluntary participation in clinical studies. Male or female aged ≥ 18 years at the time of signing the ICF. Histologically or cytologically diagnosed with ES-SCLC (according to the Veterans Administration Lung Study Group staging system). No prior systemic therapy for ES-SCLC. At least one measurable lesion as assessed according to RECIST 1.1 within 4 weeks prior to randomization. Major organs are functioning well. Every effort should be made to provide tumor tissues for the determination of PD-L1 expression. An ECOG PS score of 0 or 1. An expected survival ≥ 12 weeks. Subjects with prior denosumab use that can and agree to switch to bisphosphonate therapy for bone metastases starting prior to randomization and throughout treatment. Participant must keep contraception.
Exclusion criteria
Histologically or cytologically confirmed mixed SCLC. Known history of severe allergy to any monoclonal antibody. Known hypersensitivity to carboplatin or etoposide. Patients with myocardial infarction within half a year before the first dose of the study drug, poorly controlled arrhythmia. Pregnant or breastfeeding females. Patients with a known history of psychotropic drug abuse or drug addiction. Patients who have other factors that could lead to the early termination of this study based on the investigator's judgment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OS | A period from randomization through death regardless of causality (approximately up to 24 months). | Overall assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | approximately up to 24 months | Progression-free survival |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | approximately up to 24 months | Adverse events are described and graded using the grading categories defined in CTCAE, Version 5.0 |
| ORR | approximately up to 14 months | Objective response rate |
| Minimum Plasma Concentration (Cmin) | approximately up to 24 months | The minimum concentration (Cmin) of Serplulimab will be measured |
| Average Plasma Concentration (Cavg) | approximately up to 24 months | The average Plasma Concentration (Cavg) of Serplulimab will be measured |
| Maximum Plasma Concentration (Cmax) | approximately up to 24 months | The maximum concentration (Cmax) of Serplulimab will be measured |
Countries
United States
Outcome results
None listed