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

a study on Lung Cancer Lung Tumor

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
completion around
Principal Investigator
by David Gandara (ucdavis)

Description

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)

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)

Keywords

Extensive Stage Small Cell Lung Cancer, Anti-PD-1 Monoclonal Antibody, Lung Neoplasms, Small Cell Lung Carcinoma, Carboplatin, Etoposide, Etoposide phosphate, Atezolizumab, Serplulimab + chemotherapy (carboplatin-etoposide), Atezolizumab + chemotherapy (carboplatin-etoposide), Serplulimab + chemotherapy, Atezolizumab + chemotherapy

Eligibility

You can join if…

Open to people ages 18 years and up

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.

You CAN'T join if...

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.

Locations

  • UC Davis accepting new patients
    Sacramento California 95817 United States
  • Kaiser Permanente Research (Southern California) accepting new patients
    Los Angeles California 90034 United States
  • Compassionate Care Research Group accepting new patients
    Fountain Valley California 92708 United States
  • California Research Institute accepting new patients
    Los Angeles California 90027 United States
  • Los Angeles Cancer Network accepting new patients
    Glendale California 91204 United States
  • OPN - Oncology Physician Network accepting new patients
    Los Alamitos California 90720 United States
  • Providence Medical Foundation accepting new patients
    Fullerton California 92835 United States
  • OPN - Oncology Physician Network accepting new patients
    Arcadia California 91107 United States
  • Long Beach Memorial Medical Center accepting new patients
    Long Beach California 90806 United States

Lead Scientist at University of California Health

  • David Gandara (ucdavis)
    Professor, MED: Int Med Hematology/Oncology, School of Medicine. Authored (or co-authored) 509 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Shanghai Henlius Biotech
ID
NCT05468489
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 200 study participants
Last Updated