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

Status
Active
Cancer Type
Lung Cancer
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT05468489
Protocol IDs
ASTRIDE (HLX10-005-SCLC301-E) (primary)
NCI-2023-03864
ASTRIDE
HLX10-005-SCLC301-E
Study Sponsor
Shanghai Henlius Biotech

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)

Eligibility

  1. 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.

Treatment Sites in Georgia

City of Hope Atlanta


600 Celebrate Life Parkway
Newnan, GA 30265
770-400-6169
www.cityofhope.org/locations/atlanta/atlanta-cancer-center

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.