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This study is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of HLX10 + chemotherapy vs chemotherapy in subjects with locally advanced or metastatic squamous NSCLC who have not previously received systemic treatment.
Eligible subjects in this study will be randomized to Arm A or Arm B at 2:1 ratio as follows:
Arm A (HLX10 arm): HLX10 + chemotherapy (carboplatin nab paclitaxel) Arm B (placebo arm): Placebo + chemotherapy (carboplatin nab paclitaxel) The three stratification factors for randomization include: PD-L1 expression level (Tumor Proportion Scores [TPS]≥50%, 50%>TPS≥1%, TPS<1%), Asian population (yes or no), NSCLC stage (stage IIIB/IIIC or stage IV), and carboplatin AUC (5 or 6).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | HLX10 + chemotherapy (carboplatin nab paclitaxel) |
|
| B | Placebo Comparator | Placebo + chemotherapy (carboplatin nab paclitaxel), After 1st PD, the subject will be unblinded by the investigator and be continued with HLX10 monotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HLX10 | Drug | HLX10 is an innovative monoclonal antibody targeting PD-1,developed by Shanghai Henlius Biotech, Inc. |
|
| Measure | Description | Time Frame |
|---|---|---|
| tumor assessment | Progression-free survival (PFS) (assessed by the independent radiology review committee [IRRC] based on Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) | Baseline until disease progression or death, whichever occurs first (up to approximately 24months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology and Hematology Associates of Southwest Virginia | Roanoke | Virginia | 24014 | United States | ||
| Anhui Medical University - The Second Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38181795 | Derived | Zhou C, Hu Y, Arkania E, Kilickap S, Ying K, Xu F, Wu L, Wang X, Viguro M, Makharadze T, Sun H, Luo F, Shi J, Zang A, Pan Y, Chen Z, Jia Z, Kuchava V, Lu P, Zhang L, Cheng Y, Kang W, Wang Q, Yu H, Li J, Zhu J; ASTRUM-004 Investigators. A global phase 3 study of serplulimab plus chemotherapy as first-line treatment for advanced squamous non-small-cell lung cancer (ASTRUM-004). Cancer Cell. 2024 Feb 12;42(2):198-208.e3. doi: 10.1016/j.ccell.2023.12.004. Epub 2024 Jan 4. |
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| carboplatin and nab paclitaxel | Drug | chemotherapeutics |
|
| Placebo | Drug | Placebo |
|
| Hefei |
| Anhui |
| China |
| Anhui Provincial Hospital | Hefei | Anhui | China |
| The First Affiliated Hospital Of Anhui Medical University | Hefei | Anhui | China |
| The Second Affiliated Hospital of Anhui Medical University | Hefei | Anhui | China |
| Beijing Chaoyang Hospital | Beijing | Beijing Municipality | China |
| Beijing Friendship Hospital | Beijing | Beijing Municipality | China |
| Peking University First Hospital | Beijing | Beijing Municipality | China |
| Daping Hospital | Chongqing | Chongqing Municipality | China |
| The Second Affiliated Hospital of Army Medical University,PLA | Chongqing | Chongqing Municipality | China |
| Fujian Medical University Union Hospital | Fuzhou | Fujian | China |
| Fujian Provincial Cancer Hospital | Fuzhou | Fujian | China |
| Fuzhou Pulmonary hospital of Fujian | Fuzhou | Fujian | China |
| Gansu Wuwei Tumour Hospital | Wuwei | Gansu | China |
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | China |
| The Fifth Affiliared Hospital Sun Yat-Sen University | Zhuhai | Guangdong | China |
| Liuzhou People's Hospital | Liuzhou | Guangxi | China |
| Liuzhou Worker's Hospital | Liuzhou | Guangxi | China |
| Guangxi Medical University Affiliated Tumor Hospital | Nanning | Guangxi | China |
| The People's Hospital of Guangxi Zhuang Autonomous Region | Nanning | Guangxi | China |
| The Second Affiliated Hospital of Hainan Medical University | Haikou | Hainan | China |
| Affiliated Hospital of Hebei University | Baoding | Hebei | China |
| Cangzhou People's Hospital | Cangzhou | Hebei | China |
| Tangshan People's Hospital | Tangshan | Hebei | China |
| Harbin Medical University - Tumor Hospital (The Third Affiliated Hospital) | Harbin | Heilongjiang | China |
| The fourth affiliated hospital of Harbin medical university | Harbin | Heilongjiang | China |
| Jiamusi Cancer Hospital | Jiamusi | Heilongjiang | China |
| The Third Affiliated Hospital of Qiqihar Medical University | Qiqihar | Heilongjiang | China |
| The First Affiliated Hospital of Xinxiang Medical University | Xinxiang | Henan | China |
| Henan Cancer Hospital | Zhengzhou | Henan | China |
| Hubei Cancer Hospital | Wuhan | Hubei | China |
| Hunan Cancer Hospital | Changsha | Hunan | China |
| The Third Xiangya Hospital of Central South University | Changsha | Hunan | China |
| Xuzhou Central Hospital | Xuzhou | Jiangsu | China |
| the First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | China |
| China-japan union hospital of jilin university | Changchun | Jilin | China |
| Jilin Province Cancer Hospital | Changchun | Jilin | China |
| Jilin Province People's Hospital | Changchun | Jilin | China |
| The first hospital of Jilin University | Changchun | Jilin | China |
| The second Hospital of Jilin University | Changchun | Jilin | China |
| Chifeng Municipal Hospital | Chifeng | Neimenggu | China |
| General Hospital of Ningxia Medical University | Yinchuan | Ningxia | China |
| Shandong Cancer Hospital - Internal Medicine | Jinan | Shandong | China |
| Linyi City People Hospital | Linyi | Shandong | China |
| Shandong Linyi Tumor Hospital | Linyi | Shandong | China |
| Shanghai Eastern Hospital /Affliated Eastern Hospital of Ton | Shanghai | Shanghai Municipality | China |
| Shanghai Pulmonary Hospital | Shanghai | Shanghai Municipality | China |
| West China Hospital, Sichuan University | Chengdu | Sichuan | China |
| Tianjin Medical University Cancer Hospital | Tianjin | Tianjin Municipality | China |
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | China |
| Yunnan cancer hospital | Kunming | Yunnan | China |
| Sir Run Run Shaw Hospital, Zhejiang University | Hangzhou | Zhejiang | China |
| The First Affiliated Hospital of Zhejiang University | Hangzhou | Zhejiang | China |
| The Second Affiliated Hospital of Zhejiang University | Hangzhou | Zhejiang | China |
| High Technology Hospital MedCenter LTD | Batumi | Georgia |
| JSC Evex Clinics, St.Nikolozi Medical Centre | Kutaisi | Georgia |
| Acad.F.Todua Medical Center - Research Institute of Clinical Medicine LTD | Tbilisi | Georgia |
| Institute of Clinical Oncology LTD | Tbilisi | Georgia |
| LTD Israeli-Georgian Medical Research Clinic HELSICORE | Tbilisi | Georgia |
| Multiprofile Clinic Consilium Medula LTD | Tbilisi | Georgia |
| New Hospitals LTD | Tbilisi | Georgia |
| Scientific Research Center of Oncology LTD | Tbilisi | Georgia |
| Uniwersytecki Szpital Kliniczny w Białymstoku | Bialystok | Poland |
| Wojew. Wielospecjalistyczne Centrum Onkologii i Traumatologi | Lodz | Poland |
| LLC "VitaMed " | Moscow | Russia |
| University Clinic of Headaches | Moscow | Russia |
| Budgetary Healthcare Institution of Omsk Region "C | Omsk | Russia |
| GBUZ Orenburg Regional Clinical Oncology Dispensar | Orenburg | Russia |
| First St. Petersburg State Medical University n. a. Pavlov | Saint Petersburg | Russia |
| Limited Liability Company "AV Medical Group" | Saint Petersburg | Russia |
| LLC - Strategic Medical systems - Oncology - Oncology | Saint Petersburg | Russia |
| PMI "Evromedservice" | Saint Petersburg | Russia |
| Volgograd Regional Clinical Oncology Dispensary | Volgograd | Russia |
| Ankara University Medical Faculty - Oncology | Ankara | Turkey (Türkiye) |
| Hacettepe University Medical Faculty - Medical Oncology | Ankara | Turkey (Türkiye) |
| Trakya University Medical Faculty | Edirne | Turkey (Türkiye) |
| Istanbul University Cerrahpasa Medical Faculty | Istanbul | Turkey (Türkiye) |
| Medipol Mega Hospital | Istanbul | Turkey (Türkiye) |
| Ege University Medical Faculty | Izmir | Turkey (Türkiye) |
| Izmir Medical Park Hospital - Medical Oncology | Izmir | Turkey (Türkiye) |
| Kocaeli University Research and Practice Hospital | Kocaeli | Turkey (Türkiye) |
| Necmettin Erbakan University Meram Medical Faculty | Konya | Turkey (Türkiye) |
| Inonu University Turgut Ozal Medical Center | Malatya | Turkey (Türkiye) |
| Komunalna ustanova "Chernivets | Chernivtsi | Ukraine |
| Komunalnyi zaklad Miska bahato | Dnipro | Ukraine |
| Komunalne nekomertsiine pidpry | Kharkiv | Ukraine |
| PE PMC "Acinus" | Kirovohrad | Ukraine |
| Medychnyi tsentr "Mriya Med-Servis" | Kryvyi Rih | Ukraine |
| Limited Liability Company "Medical Center "Verum" | Kyiv | Ukraine |
| Komunalne pidpryiemstvo "Volynskyi oblasnyi medychnyi tsentr onkolohii" Volynskoyi oblasnoyi rady | Lutsk | Ukraine |
| Medychnyi tsentr "Onkolaif" LL | Zaporizhzhia | Ukraine |
| Zaporozhye Regional Clinical O | Zaporizhzhia | Ukraine |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D013660 | Taxes |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
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