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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05468489
Recruitment Status : Recruiting
First Posted : July 21, 2022
Last Update Posted : June 17, 2024
Sponsor:
Information provided by (Responsible Party):
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)

Condition or disease Intervention/treatment Phase
Extensive Stage Small Cell Lung Cancer Drug: Serplulimab + chemotherapy (carboplatin-etoposide) Drug: Atezolizumab + chemotherapy (carboplatin-etoposide) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : November 18, 2022
Estimated Primary Completion Date : October 31, 2024
Estimated Study Completion Date : December 31, 2025


Arm Intervention/treatment
Experimental: Serplulimab + chemotherapy
Serplulimab + chemotherapy (carboplatin-etoposide)
Drug: Serplulimab + chemotherapy (carboplatin-etoposide)

Drug: Serplulimab is an innovative monoclonal antibody targeting PD-1,developed by Shanghai Henlius Biotech, Inc.

Drug: carboplatin and etoposide chemotherapeutics


Active Comparator: Atezolizumab + chemotherapy
Atezolizumab + chemotherapy (carboplatin-etoposide)
Drug: Atezolizumab + chemotherapy (carboplatin-etoposide)

Drug: Atezolizumab is a monoclonal antibody targeting PD-L1,developed by Roche Pharma AG.

Drug: carboplatin and etoposide chemotherapeutics





Primary Outcome Measures :
  1. OS [ Time Frame: A period from randomization through death regardless of causality (approximately up to 24 months). ]
    Overall assessment


Secondary Outcome Measures :
  1. ORR [ Time Frame: approximately up to 14 months ]
    Objective response rate

  2. PFS [ Time Frame: approximately up to 24 months ]
    Progression-free survival

  3. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: approximately up to 24 months ]
    Adverse events are described and graded using the grading categories defined in CTCAE, Version 5.0

  4. Maximum Plasma Concentration (Cmax) [ Time Frame: approximately up to 24 months ]
    The maximum concentration (Cmax) of Serplulimab will be measured

  5. Minimum Plasma Concentration (Cmin) [ Time Frame: approximately up to 24 months ]
    The minimum concentration (Cmin) of Serplulimab will be measured

  6. Average Plasma Concentration (Cavg) [ Time Frame: approximately up to 24 months ]
    The average Plasma Concentration (Cavg) of Serplulimab will be measured



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05468489


Contacts
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Contact: Marshika Vickers 510-473-2872 marshika_vickers@henlius.com

Locations
Show Show 84 study locations
Sponsors and Collaborators
Shanghai Henlius Biotech
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Responsible Party: Shanghai Henlius Biotech
ClinicalTrials.gov Identifier: NCT05468489    
Other Study ID Numbers: ASTRIDE (HLX10-005-SCLC301-E)
First Posted: July 21, 2022    Key Record Dates
Last Update Posted: June 17, 2024
Last Verified: June 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Henlius Biotech:
Extensive Stage Small Cell Lung Cancer
Anti-PD-1 Monoclonal Antibody
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carboplatin
Etoposide
Etoposide phosphate
Atezolizumab
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immune Checkpoint Inhibitors
Antineoplastic Agents, Immunological