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

Phase 3

Recruiting

• Conditions: Extensive Stage Small Cell Lung Cancer
• Interventions: Drug: Serplulimab + chemotherapy (carboplatin-etoposide); Drug: Atezolizumab + chemotherapy (carboplatin-etoposide)

• Registration Number: NCT05468489
• Lead Sponsor: Shanghai Henlius Biotech

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-11
• Study First Submitted QC: 2022-07-19
• Study First Posted: 2022-07-21
• Study Start: 2022-11-18
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-23
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Serplulimab + chemotherapy	Serplulimab + chemotherapy (carboplatin-etoposide)	Serplulimab + chemotherapy (carboplatin-etoposide)
Atezolizumab + chemotherapy	Atezolizumab + chemotherapy (carboplatin-etoposide)	Atezolizumab + chemotherapy (carboplatin-etoposide)

Primary Outcome Measures

Name	Time	Method
OS	A period from randomization through death regardless of causality (approximately up to 24 months).	Overall assessment

Secondary Outcome Measures

Name	Time	Method
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
Maximum Plasma Concentration (Cmax)	approximately up to 24 months	The maximum concentration (Cmax) of Serplulimab will be measured
Minimum Plasma Concentration (Cmin)	approximately up to 24 months	The minimum concentration (Cmin) of Serplulimab will be measured
PFS	approximately up to 24 months	Progression-free survival
Average Plasma Concentration (Cavg)	approximately up to 24 months	The average Plasma Concentration (Cavg) of Serplulimab will be measured
ORR	approximately up to 14 months	Objective response rate

Trial Locations

Locations (97)

Alabama Oncology; 🇺🇸 Birmingham, Alabama, United States

O'Neal Comprehensive Cancer Center; 🇺🇸 Birmingham, Alabama, United States

City of Hope - Phoenix; 🇺🇸 Goodyear, Arizona, United States

Arizona Clinical Research Center (ACRC); 🇺🇸 Tucson, Arizona, United States

Highlands Oncology Group; 🇺🇸 Springdale, Arkansas, United States

OPN - Oncology Physician Network; 🇺🇸 Los Alamitos, California, United States

Compassionate Care Research Group; 🇺🇸 Fountain Valley, California, United States

Providence Medical Foundation; 🇺🇸 Fullerton, California, United States

Los Angeles Cancer Network; 🇺🇸 Glendale, California, United States

Long Beach Memorial Medical Center; 🇺🇸 Long Beach, California, United States

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