För att utvärdera effektivitet och säkerhet av HLX10 + kemoterapi (karboplatin-etoposid) hos amerikanska patienter med ES-SCLC
En randomiserad, öppen studie av HLX10 Plus-kemoterapi (karboplatin-etoposid) i jämförelse med Atezolizumab Plus-kemoterapi hos tidigare obehandlade amerikanska patienter med småcellig lungcancer i ett omfattande stadium (ES-SCLC)
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)
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 2
Kontakter och platser
Studieorter
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Alabama
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Birmingham, Alabama, Förenta staterna, 35223
- Alabama Oncology
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Arizona
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Goodyear, Arizona, Förenta staterna, 85338
- City of Hope - Phoenix
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Tucson, Arizona, Förenta staterna, 85715
- Arizona Clinical Research Center (ACRC)
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Arkansas
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Springdale, Arkansas, Förenta staterna, 72762
- Highlands Oncology Group
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California
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Fountain Valley, California, Förenta staterna, 92708
- Compassionate Care Research Group
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Fullerton, California, Förenta staterna, 92835
- Providence Medical Foundation
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Glendale, California, Förenta staterna, 91204
- Los Angeles Cancer Network
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Los Alamitos, California, Förenta staterna, 90720
- OPN - Oncology Physician Network
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Los Angeles, California, Förenta staterna, 90034
- Kaiser Permanente Research (Southern California)
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Sacramento, California, Förenta staterna, 95817
- UC Davis
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Colorado
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Colorado Springs, Colorado, Förenta staterna, 80920
- UCHealth Memorial Hospital North
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Greeley, Colorado, Förenta staterna, 80631
- MD Anderson- North Colorado Medical Center
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Florida
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Brooksville, Florida, Förenta staterna, 34613
- Advanced Cancer Treatment Centers
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Jacksonville, Florida, Förenta staterna, 32256
- Cancer Specialists North Florida
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Miami, Florida, Förenta staterna, 33140
- Mount Sinai Comprehensive Cancer Center
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Ocala, Florida, Förenta staterna, 34473
- Florida Cancer Affiliates- (Ocala Oncology - Main)
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Orange City, Florida, Förenta staterna, 32763
- Mid Florida Hematology and Oncology Center
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Plantation, Florida, Förenta staterna, 33322
- BRCR Global
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Pompano Beach, Florida, Förenta staterna, 33064
- Napa Research
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Tamarac, Florida, Förenta staterna, 33321
- Advanced Research
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Hawaii
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Honolulu, Hawaii, Förenta staterna, 96814
- Straub Benioff Medical Center
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Illinois
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Chicago, Illinois, Förenta staterna, 60099
- City of Hope- Chicago
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Decatur, Illinois, Förenta staterna, 62526
- Cancer Center of Decatur
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Tinley Park, Illinois, Förenta staterna, 60487
- Accellacare of Duly
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Indiana
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Dyer, Indiana, Förenta staterna, 46311
- Northwest Cancer Centers
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Kansas
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Wichita, Kansas, Förenta staterna, 67214
- Cancer Center of Kansas
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Kentucky
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Lexington, Kentucky, Förenta staterna, 40503
- Baptist Health Lexington
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Pikeville, Kentucky, Förenta staterna, 41501
- Pikeville Hospital
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Louisiana
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Alexandria, Louisiana, Förenta staterna, 71301
- CHRISTUS St. Frances Cabrini Cancer Center
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Hammond, Louisiana, Förenta staterna, 70433
- Pontchartrain Cancer Center
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Michigan
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Southfield, Michigan, Förenta staterna, 48075
- Henry Ford Health Providence Southfield Hospital
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Minnesota
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Saint Paul, Minnesota, Förenta staterna, 55101
- Health Partners Cancer Center at Regions Hospital
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Mississippi
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Hattiesburg, Mississippi, Förenta staterna, 39401
- Hattiesburg Clinic Hematology/Oncology
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Missouri
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Kansas City, Missouri, Förenta staterna, 64132
- MidAmerica Division Inc., c/o Research Medical Center
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Osage Beach, Missouri, Förenta staterna, 65065
- Lake Regional
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Montana
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Billings, Montana, Förenta staterna, 59102
- St. Vincent Frontier Cancer Center
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Nebraska
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Omaha, Nebraska, Förenta staterna, 68106
- University of Nebraska Medical Center
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Nevada
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Reno, Nevada, Förenta staterna, 89502
- Renown Health
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New Hampshire
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Lebanon, New Hampshire, Förenta staterna, 03756
- Dartmouth Hitchcock Medical Center
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New Jersey
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Freehold, New Jersey, Förenta staterna, 03756
- Regional Cancer Care Associates LLC RCCA
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Neptune City, New Jersey, Förenta staterna, 07753
- Jersey Shore University Medical Center
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New York
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Elmhurst, New York, Förenta staterna, 11373
- Elmhurst (BRANY site)
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Lake Success, New York, Förenta staterna, 11042
- Northwell Health
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Stony Brook, New York, Förenta staterna, 11794
- Stony Brook Cancer Center
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Williamsville, New York, Förenta staterna, 14221
- Great Lakes Cancer Care (Kaleida Health)
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Ohio
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Akron, Ohio, Förenta staterna, 44304
- Summa Health
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Canton, Ohio, Förenta staterna, 44708
- Cleveland Clinic Mercy Hospital
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Canton, Ohio, Förenta staterna, 44710
- Aultman Cancer Center
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Cleveland, Ohio, Förenta staterna, 44106
- University Hospitals Cleveland Medical Center
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Massillon, Ohio, Förenta staterna, 44646
- Tricounty Hematology and Oncology Associates
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Pennsylvania
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Wynnewood, Pennsylvania, Förenta staterna, 19096
- Lankenau Medical Center
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Rhode Island
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Providence, Rhode Island, Förenta staterna, 02908
- CharterCARE (Roger Williams)
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Texas
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Corpus Christi, Texas, Förenta staterna, 78404
- CHRISTUS Institute for Innovation & Advanced Clinical Care
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Edinburg, Texas, Förenta staterna, 78539
- DHR Research
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Houston, Texas, Förenta staterna, 77090
- Millennium Research and Clinical Development
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Kingwood, Texas, Förenta staterna, 77339
- Lumi Research
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Lubbock, Texas, Förenta staterna, 79410
- Joe Arrington Cancer Research and Treatment Center
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Tyler, Texas, Förenta staterna, 75701
- The University of Texas Health Science Center at Tyler/HOPE Cancer Center
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Utah
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Salt Lake City, Utah, Förenta staterna, 84106
- Utah Cancer Specialists
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Salt Lake City, Utah, Förenta staterna, 84112
- Huntsman Cancer Institute
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Washington
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Olympia, Washington, Förenta staterna, 98502
- American Oncology Network Vista Oncology Division
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Tacoma, Washington, Förenta staterna, 98405
- Northwest Medical Specialties, PLLC
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West Virginia
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Morgantown, West Virginia, Förenta staterna, 26505
- West Virginia University Cancer Institute
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Wisconsin
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Madison, Wisconsin, Förenta staterna, 53792
- University of Wisconsin Carbone Cancer Center
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Milwaukee, Wisconsin, Förenta staterna, 53226
- Froedtert Hospital- Medical College of Wisconsin
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Patients who have received chemoradiotherapy for previous limited stage SCLC must be treated with curative intent and have a treatment-free interval of at least 6 months from the last course of chemotherapy, radiotherapy, or chemoradiotherapy to the diagnosis of extensive stage SCLC.
At least one measurable lesion as assessed according to RECIST 1.1 within 4 weeks prior to randomization.
Every effort should be made to provide tumor tissues for the determination of PD-L1 expression.
Prior antineoplastic therapy including Chinese medicine therapy, which has been approved as antineoplastic therapy by NMPA or its instruction has antineoplastic therapy effect, must have been ≥ 2 weeks from the first dose in this study with treatment-related AEs resolved to NCI-CTCAE Grade ≤ 1 (except for Grade 2 alopecia).
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.
Normal major organ functions.
Female patients must meet one of the following conditions: Menopause, Surgically sterilized or of child-bearing potential, must meet the following: negative serum pregnancy test within 7 days prior to randomization and agree to use birth control methods with an annual failure rate <1% or maintain abstinence. Must not be breast-feeding.
Male patients must: agree to abstinence or take contraception measures as follows: male patients with a pregnant partner or a partner of childbearing potential must remain abstinent or use a condom or had vasectomy to prevent embryonic exposure during study treatment and for at least 6 months after the last dose of study drug. Periodic abstinence and external ejaculation are ineligible methods of contraception.
Exclusion Criteria:
Histologically or cytologically confirmed mixed SCLC.
Other active malignancies within 5 years or at the same time. Localized tumors that have been cured, such as basal cell carcinoma, squamous-cell skin cancer, superficial bladder cancer, prostate carcinoma in situ, cervical cancer in situ and breast cancer in situ are acceptable.
Patients who are preparing for or have received an organ or bone marrow transplant.
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Patients with indwelling catheters are allowed regardless of drainage frequency.
Patients with known or documented active CNS metastases and/or carcinomatous meningitis at screening. However, the following subjects are allowed to be enrolled: 1) Subjects with asymptomatic brain metastases may be included but are required to receive regular brain imaging as a site of lesion. 2) Subjects with treated brain metastases which have been stable for at least 2 weeks, with no evidence of new or enlarging brain metastases, and with discontinued steroids 3 days prior to study drug administration.
Subjects with spinal cord compression that has not been treated with surgery and/or radiotherapy.
Patients with myocardial infarction within half a year before the first dose of the study drug, poorly controlled arrhythmia.
Class III to IV cardiac insufficiency according to NYHA classification.
Subject has uncontrolled or symptomatic hypercalcemia.
Subject with peripheral neuropathy ≥ Grade 2 by CTCAE.
Human immunodeficiency virus (HIV) infection, positive test for HIV antibody.
Active or latent pulmonary tuberculosis.
Subjects with previous and concurrent interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis and severe impaired pulmonary function that may interfere with the detection and management of suspected drug-related pulmonary toxicity, as judged by the investigator.
Hepatitis B or Hepatitis C or Hepatitis B and C co-infection.
Known active or suspected autoimmune diseases. Subjects in a stable state with no need for systemic immunosuppressant therapy are allowed to enroll.
Have received treatment with live vaccines within 28 days prior to the first administration. Subjects may receive inactivated viral vaccines for seasonal influenza but may not receive live attenuated influenza vaccines via intranasal route.
Subjects requiring treatment with systemic corticosteroids or other immunosuppressive drugs within 14 days prior to the first dose or during the study. However, in the absence of active autoimmune disease, subjects are allowed to use topical or inhaled steroids and adrenal hormone replacement therapy at doses equivalent to ≤ 10 mg/day of prednisone efficacy.
With any active infection requiring systemic anti-infective treatment at the time of first dose of study treatment.
Major surgery within 28 days prior to the first dose of the study drug, defined as: surgeries requiring at least 3 weeks of recovery to be able to receive treatment in this study.
Radical radiation therapy within 3 months prior to study medications. Note: Palliative radiotherapy to bone or palliative radiotherapy to superficial lesions is allowed according to local standards 14 days prior to the first dose. Radiotherapy covering more than 30% of the bone marrow area within 28 days prior to the first dose is not allowed.
The subject has previously received other antibodies/drugs against immune checkpoints, such as PD-1, PD-L1, CTLA4, etc.
Participation in any other ongoing clinical studies, or less than 14 days from the end of the previous clinical study treatment to the start of this trial.
Known history of severe allergy to any monoclonal antibody.
Known hypersensitivity to carboplatin or etoposide.
Pregnant or lactating females.
Active use of psychotropics abuse or drug abuse.
In the judgment of the investigator, the subject has any other factors that may lead to a premature discontinuation.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Serplulimab + chemotherapy
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 |
|
Aktiv komparator: Atezolizumab + chemotherapy
Atezolizumab + chemotherapy (carboplatin-etoposide) |
Drug: Atezolizumab is a monoclonal antibody targeting PD-L1，developed by Roche Pharma AG. Drug: carboplatin and etoposide chemotherapeutics |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
OS
Tidsram: A period from randomization through death regardless of causality (approximately up to 24 months).
|
Overall assessment |
A period from randomization through death regardless of causality (approximately up to 24 months).
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Objective response rate (ORR)
Tidsram: approximately up to 14 months
|
Objective response rate (ORR) (assessed by independent radiology review committee [IRRC] and the investigator based on Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) |
approximately up to 14 months
|
|
Progression-free survival (PFS)
Tidsram: approximately up to 24 months
|
Progression-free survival (PFS) (assessed by IRRC and the investigator based on RECIST 1.1) |
approximately up to 24 months
|
|
PFS2
Tidsram: Approximately up to 24 months
|
PFS2 (assessed by the investigator based on RECIST 1.1) |
Approximately up to 24 months
|
|
Duration of response (DOR)
Tidsram: Approximately up to 24 months
|
Duration of response (DOR) (assessed by IRRC and the investigator based on RECIST 1.1) |
Approximately up to 24 months
|
|
Adverse events
Tidsram: approximately up to 24 months
|
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment. |
approximately up to 24 months
|
|
Observed concentration of HLX10 in serum
Tidsram: Approximately up to 24 months
|
Observed concentration of HLX10 in serum |
Approximately up to 24 months
|
|
Estimated PK exposure of HLX10 in serum from population pharmacokinetic analysis, expressed as mg·h/L
Tidsram: Approximately up to 24 months
|
The PK data obtained in this study will be pooled with other data from HLX10 (Serplulimab) clinical trials for further population pharmacokinetic analyses. The differences in PK exposure between American population and the obtained populations (Asian and non-Asian) will be compared through model simulation. |
Approximately up to 24 months
|
|
HLX10 anti-drug antibody (ADA)
Tidsram: Approximately up to 24 months
|
HLX10 anti-drug antibody (ADA) |
Approximately up to 24 months
|
|
Neutralizing antibody (NAb)
Tidsram: Approximately up to 24 months
|
Neutralizing antibody (NAb) positive rate |
Approximately up to 24 months
|
|
Quality of life assessment
Tidsram: Approximately up to 24 months
|
Lung cancer Quality of life assessment |
Approximately up to 24 months
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Exploratory Endpoint
Tidsram: Approximately up to 24 months
|
Potential prognostic and predictive biomarkers, including PD-L1 expression in tumor tissue and SCLC-related blood biomarker |
Approximately up to 24 months
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ASTRIDE (HLX10-005-SCLC301-E)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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