米国の ES-SCLC 患者における HLX10 + 化学療法 (カルボプラチン - エトポシド) の有効性と安全性を評価する
未治療の進行期小細胞肺癌（ES-SCLC）米国患者におけるHLX10プラス化学療法（カルボプラチン-エトポシド）とアテゾリズマブプラス化学療法との比較における無作為化非盲検試験
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)
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究場所
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Alabama
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Birmingham、Alabama、アメリカ、35223
- Alabama Oncology
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Arizona
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Goodyear、Arizona、アメリカ、85338
- City of Hope - Phoenix
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Tucson、Arizona、アメリカ、85715
- Arizona Clinical Research Center (ACRC)
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Arkansas
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Springdale、Arkansas、アメリカ、72762
- Highlands Oncology Group
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California
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Fountain Valley、California、アメリカ、92708
- Compassionate Care Research Group
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Fullerton、California、アメリカ、92835
- Providence Medical Foundation
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Glendale、California、アメリカ、91204
- Los Angeles Cancer Network
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Los Alamitos、California、アメリカ、90720
- OPN - Oncology Physician Network
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Los Angeles、California、アメリカ、90034
- Kaiser Permanente Research (Southern California)
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Sacramento、California、アメリカ、95817
- UC Davis
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Colorado
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Colorado Springs、Colorado、アメリカ、80920
- UCHealth Memorial Hospital North
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Greeley、Colorado、アメリカ、80631
- MD Anderson- North Colorado Medical Center
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Florida
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Brooksville、Florida、アメリカ、34613
- Advanced Cancer Treatment Centers
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Jacksonville、Florida、アメリカ、32256
- Cancer Specialists North Florida
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Miami、Florida、アメリカ、33140
- Mount Sinai Comprehensive Cancer Center
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Ocala、Florida、アメリカ、34473
- Florida Cancer Affiliates- (Ocala Oncology - Main)
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Orange City、Florida、アメリカ、32763
- Mid Florida Hematology and Oncology Center
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Plantation、Florida、アメリカ、33322
- BRCR Global
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Pompano Beach、Florida、アメリカ、33064
- Napa Research
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Tamarac、Florida、アメリカ、33321
- Advanced Research
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Hawaii
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Honolulu、Hawaii、アメリカ、96814
- Straub Benioff Medical Center
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Illinois
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Chicago、Illinois、アメリカ、60099
- City of Hope- Chicago
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Decatur、Illinois、アメリカ、62526
- Cancer Center of Decatur
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Tinley Park、Illinois、アメリカ、60487
- Accellacare of Duly
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Indiana
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Dyer、Indiana、アメリカ、46311
- Northwest Cancer Centers
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Kansas
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Wichita、Kansas、アメリカ、67214
- Cancer Center of Kansas
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Kentucky
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Lexington、Kentucky、アメリカ、40503
- Baptist Health Lexington
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Pikeville、Kentucky、アメリカ、41501
- Pikeville Hospital
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Louisiana
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Alexandria、Louisiana、アメリカ、71301
- CHRISTUS St. Frances Cabrini Cancer Center
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Hammond、Louisiana、アメリカ、70433
- Pontchartrain Cancer Center
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Michigan
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Southfield、Michigan、アメリカ、48075
- Henry Ford Health Providence Southfield Hospital
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Minnesota
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Saint Paul、Minnesota、アメリカ、55101
- Health Partners Cancer Center at Regions Hospital
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Mississippi
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Hattiesburg、Mississippi、アメリカ、39401
- Hattiesburg Clinic Hematology/Oncology
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Missouri
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Kansas City、Missouri、アメリカ、64132
- MidAmerica Division Inc., c/o Research Medical Center
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Osage Beach、Missouri、アメリカ、65065
- Lake Regional
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Montana
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Billings、Montana、アメリカ、59102
- St. Vincent Frontier Cancer Center
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Nebraska
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Omaha、Nebraska、アメリカ、68106
- University of Nebraska Medical Center
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Nevada
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Reno、Nevada、アメリカ、89502
- Renown Health
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New Hampshire
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Lebanon、New Hampshire、アメリカ、03756
- Dartmouth Hitchcock Medical Center
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New Jersey
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Freehold、New Jersey、アメリカ、03756
- Regional Cancer Care Associates LLC RCCA
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Neptune City、New Jersey、アメリカ、07753
- Jersey Shore University Medical Center
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New York
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Elmhurst、New York、アメリカ、11373
- Elmhurst (BRANY site)
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Lake Success、New York、アメリカ、11042
- Northwell Health
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Stony Brook、New York、アメリカ、11794
- Stony Brook Cancer Center
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Williamsville、New York、アメリカ、14221
- Great Lakes Cancer Care (Kaleida Health)
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Ohio
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Akron、Ohio、アメリカ、44304
- Summa Health
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Canton、Ohio、アメリカ、44708
- Cleveland Clinic Mercy Hospital
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Canton、Ohio、アメリカ、44710
- Aultman Cancer Center
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Cleveland、Ohio、アメリカ、44106
- University Hospitals Cleveland Medical Center
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Massillon、Ohio、アメリカ、44646
- Tricounty Hematology and Oncology Associates
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Pennsylvania
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Wynnewood、Pennsylvania、アメリカ、19096
- Lankenau Medical Center
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Rhode Island
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Providence、Rhode Island、アメリカ、02908
- CharterCARE (Roger Williams)
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Texas
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Corpus Christi、Texas、アメリカ、78404
- CHRISTUS Institute for Innovation & Advanced Clinical Care
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Edinburg、Texas、アメリカ、78539
- DHR Research
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Houston、Texas、アメリカ、77090
- Millennium Research and Clinical Development
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Kingwood、Texas、アメリカ、77339
- Lumi Research
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Lubbock、Texas、アメリカ、79410
- Joe Arrington Cancer Research and Treatment Center
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Tyler、Texas、アメリカ、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、アメリカ、84106
- Utah Cancer Specialists
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Salt Lake City、Utah、アメリカ、84112
- Huntsman Cancer Institute
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Washington
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Olympia、Washington、アメリカ、98502
- American Oncology Network Vista Oncology Division
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Tacoma、Washington、アメリカ、98405
- Northwest Medical Specialties, PLLC
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West Virginia
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Morgantown、West Virginia、アメリカ、26505
- West Virginia University Cancer Institute
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Wisconsin
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Madison、Wisconsin、アメリカ、53792
- University of Wisconsin Carbone Cancer Center
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Milwaukee、Wisconsin、アメリカ、53226
- Froedtert Hospital- Medical College of Wisconsin
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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 |
|
アクティブコンパレータ：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 |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
OS
時間枠：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).
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Objective response rate (ORR)
時間枠：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)
時間枠：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
時間枠：Approximately up to 24 months
|
PFS2 (assessed by the investigator based on RECIST 1.1) |
Approximately up to 24 months
|
|
Duration of response (DOR)
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：Approximately up to 24 months
|
HLX10 anti-drug antibody (ADA) |
Approximately up to 24 months
|
|
Neutralizing antibody (NAb)
時間枠：Approximately up to 24 months
|
Neutralizing antibody (NAb) positive rate |
Approximately up to 24 months
|
|
Quality of life assessment
時間枠：Approximately up to 24 months
|
Lung cancer Quality of life assessment |
Approximately up to 24 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Exploratory Endpoint
時間枠：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
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。