Clinical trial NCT04033354: 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
Official title: A Randomized, Double-Blind, Multicenter, Phase III Clinical Study of HLX10 (Recombinant Anti-PD-1 Humanized Monoclonal Antibody Injection) + Chemotherapy (Carboplatin Nanoparticle Albumin Bound (Nab)-Paclitaxel) vs Chemotherapy (Carboplatin Nab-Paclitaxel) as First-Line Therapy for Locally Advanced or Metastatic Squamous Non Small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Squamous Non Small Cell Lung Cancer
Keywords: Locally Advanced or Metastatic
Squamous Non Small Cell Lung Cancer
Lead sponsor: Shanghai Henlius Biotech
Sponsor class: INDUSTRY
First posted: 2019-07-26
Enrollment: 537
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. 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.
2. Patients with known history of severe hypersensitivity to any monoclonal antibody.
3. Patients with known hypersensitivity to any compositions of carboplatin or nab-paclitaxel.
4. Pregnant or breastfeeding females.
5. Patients with a known history of psychotropic drug abuse or drug addiction; or a history of alcohol abuse.
6. Patients who have other factors that could lead to the early termination of this study based on the investigator's judgment.

Primary outcomes:
measure: tumor assessment
timeFrame: Baseline until disease progression or death, whichever occurs first (up to approximately 24months)
Secondary outcomes:
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Oncology and Hematology Associates of Southwest Virginia
state: Virginia
city: Hefei
country: China
facility: Anhui Medical University - The Second Hospital
state: Anhui
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Hefei
country: China
facility: The First Affiliated Hospital Of Anhui Medical University
state: Anhui
city: Hefei
country: China
facility: The Second Affiliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Beijing Chaoyang Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Chongqing
country: China
facility: Daping Hospital
state: Chongqing
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Army Medical University,PLA
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospital
state: Fujian
city: Fuzhou
country: China
facility: Fuzhou Pulmonary hospital of Fujian
state: Fujian
city: Wuwei
country: China
facility: Gansu Wuwei Tumour Hospital
state: Gansu
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Zhuhai
country: China
facility: The Fifth Affiliared Hospital Sun Yat-Sen University
state: Guangdong
city: Liuzhou
country: China
facility: Liuzhou People's Hospital
state: Guangxi
city: Liuzhou
country: China
facility: Liuzhou Worker's Hospital
state: Guangxi
city: Nanning
country: China
facility: Guangxi Medical University Affiliated Tumor Hospital
state: Guangxi
city: Nanning
country: China
facility: The People's Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi
city: Haikou
country: China
facility: The Second Affiliated Hospital of Hainan Medical University
state: Hainan
city: Baoding
country: China
facility: Affiliated Hospital of Hebei University
state: Hebei
city: Cangzhou
country: China
facility: Cangzhou People's Hospital
state: Hebei
city: Tangshan
country: China
facility: Tangshan People's Hospital
state: Hebei
city: Ha'erbin
country: China
facility: Harbin Medical University - Tumor Hospital (The Third Affiliated Hospital)
state: Heilongjiang
city: Ha'erbin
country: China
facility: The fourth affiliated hospital of Harbin medical university
state: Heilongjiang
city: Jiamusi
country: China
facility: Jiamusi Cancer Hospital
state: Heilongjiang
city: Qiqihar
country: China
facility: The Third Affiliated Hospital of Qiqihar Medical University
state: Heilongjiang
city: Xinxiang
country: China
facility: The First Affiliated Hospital of Xinxiang Medical University
state: Henan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
state: Jiangsu
city: Nanchang
country: China
facility: the First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: China-japan union hospital of jilin university
state: Jilin
city: Changchun
country: China
facility: Jilin Province Cancer Hospital
state: Jilin
city: Changchun
country: China
facility: Jilin Province People's Hospital
state: Jilin
city: Changchun
country: China
facility: The first hospital of Jilin University
state: Jilin
city: Changchun
country: China
facility: The second Hospital of Jilin University
state: Jilin
city: Chifeng
country: China
facility: Chifeng Municipal Hospital
state: Neimenggu
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Jinan
country: China
facility: Shandong Cancer Hospital - Internal Medicine
state: Shandong
city: Linyi
country: China
facility: Linyi City People Hospital
state: Shandong
city: Linyi
country: China
facility: Shandong Linyi Tumor Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Eastern Hospital /Affliated Eastern Hospital of Ton
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Kunming
country: China
facility: Yunnan cancer hospital
state: Yunnan
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University
state: Zhejiang
city: Batumi
country: Georgia
facility: High Technology Hospital MedCenter LTD
city: Kutaisi
country: Georgia
facility: JSC Evex Clinics, St.Nikolozi Medical Centre
city: Tbilisi
country: Georgia
facility: Acad.F.Todua Medical Center - Research Institute of Clinical Medicine LTD
city: Tbilisi
country: Georgia
facility: Institute of Clinical Oncology LTD
city: Tbilisi
country: Georgia
facility: LTD Israeli-Georgian Medical Research Clinic HELSICORE
city: Tbilisi
country: Georgia
facility: Multiprofile Clinic Consilium Medula LTD
city: Tbilisi
country: Georgia
facility: New Hospitals LTD
city: Tbilisi
country: Georgia
facility: Scientific Research Center of Oncology LTD
city: Białystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Białymstoku
city: Łódź
country: Poland
facility: Wojew. Wielospecjalistyczne Centrum Onkologii i Traumatologi
city: Moscow
country: Russian Federation
facility: LLC "VitaMed "
city: Moscow
country: Russian Federation
facility: University Clinic of Headaches
city: Omsk
country: Russian Federation
facility: Budgetary Healthcare Institution of Omsk Region "C
city: Orenburg
country: Russian Federation
facility: GBUZ Orenburg Regional Clinical Oncology Dispensar
city: Saint Petersburg
country: Russian Federation
facility: First St. Petersburg State Medical University n. a. Pavlov
city: Saint Petersburg
country: Russian Federation
facility: Limited Liability Company "AV Medical Group"
city: Saint Petersburg
country: Russian Federation
facility: LLC - Strategic Medical systems - Oncology - Oncology
city: Saint Petersburg
country: Russian Federation
facility: PMI "Evromedservice"
city: Volgograd
country: Russian Federation
facility: Volgograd Regional Clinical Oncology Dispensary
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty - Oncology
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty - Medical Oncology
city: Edirne
country: Turkey
facility: Trakya University Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty
city: Istanbul
country: Turkey
facility: Medipol Mega Hospital
city: İzmir
country: Turkey
facility: Ege University Medical Faculty
city: İzmir
country: Turkey
facility: Izmir Medical Park Hospital - Medical Oncology
city: Kocaeli
country: Turkey
facility: Kocaeli University Research and Practice Hospital
city: Konya
country: Turkey
facility: Necmettin Erbakan University Meram Medical Faculty
city: Malatya
country: Turkey
facility: Inonu University Turgut Ozal Medical Center
city: Chernivtsi
country: Ukraine
facility: Komunalna ustanova "Chernivets
city: Dnipro
country: Ukraine
facility: Komunalnyi zaklad Miska bahato
city: Kharkiv
country: Ukraine
facility: Komunalne nekomertsiine pidpry
city: Kirovohrad
country: Ukraine
facility: PE PMC "Acinus"
city: Kryvyi Rih
country: Ukraine
facility: Medychnyi tsentr "Mriya Med-Servis"
city: Kyiv
country: Ukraine
facility: Limited Liability Company "Medical Center "Verum"
city: Luts'k
country: Ukraine
facility: Komunalne pidpryiemstvo "Volynskyi oblasnyi medychnyi tsentr onkolohii" Volynskoyi oblasnoyi rady
city: Zaporizhzhia
country: Ukraine
facility: Medychnyi tsentr "Onkolaif" LL
city: Zaporizhzhia
country: Ukraine
facility: Zaporozhye Regional Clinical O
Study officials:
References: