To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC

Study Overview
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Brief Summary
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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)

Official Title
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A Randomized, Open-label Study of Serplulimab Plus Chemotherapy (Carboplatin-Etoposide) in Comparison With Atezolizumab Plus Chemotherapy in Previously Untreated US Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) (ASTRIDE)

Conditions
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Extensive Stage Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Serplulimab + chemotherapy (carboplatin-etoposide)
* Drug: Atezolizumab + chemotherapy (carboplatin-etoposide)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Serplulimab + chemotherapy<br>Serplulimab + chemotherapy (carboplatin-etoposide) | Drug: Serplulimab + chemotherapy (carboplatin-etoposide)<br>* Drug: Serplulimab is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc. Drug: carboplatin and etoposide chemotherapeutics<br>|
| Active Comparator: Atezolizumab + chemotherapy<br>Atezolizumab + chemotherapy (carboplatin-etoposide) | Drug: Atezolizumab + chemotherapy (carboplatin-etoposide)<br>* Drug: Atezolizumab is a monoclonal antibody targeting PD-L1，developed by Roche Pharma AG. Drug: carboplatin and etoposide chemotherapeutics<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | Overall assessment | A period from randomization through death regardless of causality (approximately up to 24 months). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Objective response rate | approximately up to 14 months | 
| PFS | Progression-free survival | approximately up to 24 months | 
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Adverse events are described and graded using the grading categories defined in CTCAE, Version 5.0 | approximately up to 24 months | 
| Maximum Plasma Concentration (Cmax) | The maximum concentration (Cmax) of Serplulimab will be measured | approximately up to 24 months | 
| Minimum Plasma Concentration (Cmin) | The minimum concentration (Cmin) of Serplulimab will be measured | approximately up to 24 months | 
| Average Plasma Concentration (Cavg) | The average Plasma Concentration (Cavg) of Serplulimab will be measured | approximately up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extensive Stage Small Cell Lung Cancer, Anti-PD-1 Monoclonal Antibody