Lung Cancer Clinical Trial

A Randomized, Double-blind, Placebo Controlled Phase III Study to Investigate Efficacy and Safety of First-Line Treatment With HLX10 + Chemotherapy (Carboplatin-Nanoparticle Albumin Bound (Nab) Paclitaxel) in Patients With Stage IIIB/IIIC or IV NSCLC

Summary

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).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patients with histologically or cytologically confirmed stage IIIB/IIIC and stage IV (AJCC Edition 8) squamous NSCLC where surgery or radiotherapy cannot be performed.
No known sensitizing EGFR mutations or ALK, ROS1 gene rearrangements.
Major organs are functioning well
Participant must keep contraception
Patients with prior denosumab use who can agree to switch to bisphosphonate therapy for bone metastases in the study.

Exclusion Criteria:

Patients with histologically non-squamous NSCLC. Mixed tumors will be classified according to the primary cell type. Patients do not meet the requirements for enrollment if small cell components and neuroendocrine carcinoma components are present. For non-small cell histology, patients meet the requirements for enrollment if squamous components (e.g., adenosquamous) are present.
Patients with known history of severe hypersensitivity to any monoclonal antibody.
Patients with known hypersensitivity to any compositions of carboplatin or nab-paclitaxel.
Pregnant or breastfeeding females.
Patients with a known history of psychotropic drug abuse or drug addiction; or a history of alcohol abuse.
Patients who have other factors that could lead to the early termination of this study based on the investigator's judgment.

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

537

Study ID:

NCT04033354

Recruitment Status:

Active, not recruiting

Sponsor:

Shanghai Henlius Biotech

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There is 1 Location for this study

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Oncology and Hematology Associates of Southwest Virginia
Roanoke Virginia, 24014, United States
Anhui Medical University - The Second Hospital
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, , China
Beijing Friendship Hospital
Beijing Beijing, , China
Peking University First Hospital
Beijing Beijing, , China
Daping Hospital
Chongqing Chongqing, , China
The Second Affiliated Hospital of Army Medical University,PLA
Chongqing Chongqing, , 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)
Ha'erbin Heilongjiang, , China
The fourth affiliated hospital of Harbin medical university
Ha'erbin 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, , China
Shanghai Pulmonary Hospital
Shanghai Shanghai, , China
West China Hospital, Sichuan University
Chengdu Sichuan, , China
Tianjin Medical University Cancer Hospital
Tianjin Tianjin, , China
Tianjin Medical University General Hospital
Tianjin Tianjin, , 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
Białystok , , Poland
Wojew. Wielospecjalistyczne Centrum Onkologii i Traumatologi
Łódź , , Poland
LLC "VitaMed "
Moscow , , Russian Federation
University Clinic of Headaches
Moscow , , Russian Federation
Budgetary Healthcare Institution of Omsk Region "C
Omsk , , Russian Federation
GBUZ Orenburg Regional Clinical Oncology Dispensar
Orenburg , , Russian Federation
First St. Petersburg State Medical University n. a. Pavlov
Saint Petersburg , , Russian Federation
Limited Liability Company "AV Medical Group"
Saint Petersburg , , Russian Federation
LLC - Strategic Medical systems - Oncology - Oncology
Saint Petersburg , , Russian Federation
PMI "Evromedservice"
Saint Petersburg , , Russian Federation
Volgograd Regional Clinical Oncology Dispensary
Volgograd , , Russian Federation
Ankara University Medical Faculty - Oncology
Ankara , , Turkey
Hacettepe University Medical Faculty - Medical Oncology
Ankara , , Turkey
Trakya University Medical Faculty
Edirne , , Turkey
Istanbul University Cerrahpasa Medical Faculty
Istanbul , , Turkey
Medipol Mega Hospital
Istanbul , , Turkey
Ege University Medical Faculty
Ä°zmir , , Turkey
Izmir Medical Park Hospital - Medical Oncology
Ä°zmir , , Turkey
Kocaeli University Research and Practice Hospital
Kocaeli , , Turkey
Necmettin Erbakan University Meram Medical Faculty
Konya , , Turkey
Inonu University Turgut Ozal Medical Center
Malatya , , Turkey
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
Luts'k , , Ukraine
Medychnyi tsentr "Onkolaif" LL
Zaporizhzhia , , Ukraine
Zaporozhye Regional Clinical O
Zaporizhzhia , , Ukraine

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

537

Study ID:

NCT04033354

Recruitment Status:

Active, not recruiting

Sponsor:


Shanghai Henlius Biotech

How clear is this clinincal trial information?

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