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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

Primary Purpose

Squamous Non Small Cell Lung Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
HLX10
carboplatin and nab paclitaxel
Placebo
Sponsored by
Shanghai Henlius Biotech
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Squamous Non Small Cell Lung Cancer focused on measuring Locally Advanced or Metastatic, Squamous Non Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Oncology and Hematology Associates of Southwest Virginia
  • Anhui Medical University - The Second Hospital
  • Anhui Provincial Hospital
  • The First Affiliated Hospital Of Anhui Medical University
  • The Second Affiliated Hospital of Anhui Medical University
  • Beijing Chaoyang Hospital
  • Beijing Friendship Hospital
  • Peking University First Hospital
  • Daping Hospital
  • The Second Affiliated Hospital of Army Medical University,PLA
  • Fujian Medical University Union Hospital
  • Fujian Provincial Cancer Hospital
  • Fuzhou Pulmonary hospital of Fujian
  • Gansu Wuwei Tumour Hospital
  • The First Affiliated Hospital of Guangzhou Medical University
  • The Fifth Affiliared Hospital Sun Yat-Sen University
  • Liuzhou People's Hospital
  • Liuzhou Worker's Hospital
  • Guangxi Medical University Affiliated Tumor Hospital
  • The People's Hospital of Guangxi Zhuang Autonomous Region
  • The Second Affiliated Hospital of Hainan Medical University
  • Affiliated Hospital of Hebei University
  • Cangzhou People's Hospital
  • Tangshan People's Hospital
  • Harbin Medical University - Tumor Hospital (The Third Affiliated Hospital)
  • The fourth affiliated hospital of Harbin medical university
  • Jiamusi Cancer Hospital
  • The Third Affiliated Hospital of Qiqihar Medical University
  • The First Affiliated Hospital of Xinxiang Medical University
  • Henan Cancer Hospital
  • Hubei Cancer Hospital
  • Hunan Cancer Hospital
  • The Third Xiangya Hospital of Central South University
  • Xuzhou Central Hospital
  • the First Affiliated Hospital of Nanchang University
  • China-japan union hospital of jilin university
  • Jilin Province Cancer Hospital
  • Jilin Province People's Hospital
  • The first hospital of Jilin University
  • The second Hospital of Jilin University
  • Chifeng Municipal Hospital
  • General Hospital of Ningxia Medical University
  • Shandong Cancer Hospital - Internal Medicine
  • Linyi City People Hospital
  • Shandong Linyi Tumor Hospital
  • Shanghai Eastern Hospital /Affliated Eastern Hospital of Ton
  • Shanghai Pulmonary Hospital
  • West China Hospital, Sichuan University
  • Tianjin Medical University Cancer Hospital
  • Tianjin Medical University General Hospital
  • Yunnan cancer hospital
  • Sir Run Run Shaw Hospital, Zhejiang University
  • The First Affiliated Hospital of Zhejiang University
  • The Second Affiliated Hospital of Zhejiang University
  • High Technology Hospital MedCenter LTD
  • JSC Evex Clinics, St.Nikolozi Medical Centre
  • Acad.F.Todua Medical Center - Research Institute of Clinical Medicine LTD
  • Institute of Clinical Oncology LTD
  • LTD Israeli-Georgian Medical Research Clinic HELSICORE
  • Multiprofile Clinic Consilium Medula LTD
  • New Hospitals LTD
  • Scientific Research Center of Oncology LTD
  • Uniwersytecki Szpital Kliniczny w Białymstoku
  • Wojew. Wielospecjalistyczne Centrum Onkologii i Traumatologi
  • LLC "VitaMed "
  • University Clinic of Headaches
  • Budgetary Healthcare Institution of Omsk Region "C
  • GBUZ Orenburg Regional Clinical Oncology Dispensar
  • First St. Petersburg State Medical University n. a. Pavlov
  • Limited Liability Company "AV Medical Group"
  • LLC - Strategic Medical systems - Oncology - Oncology
  • PMI "Evromedservice"
  • Volgograd Regional Clinical Oncology Dispensary
  • Ankara University Medical Faculty - Oncology
  • Hacettepe University Medical Faculty - Medical Oncology
  • Trakya University Medical Faculty
  • Istanbul University Cerrahpasa Medical Faculty
  • Medipol Mega Hospital
  • Ege University Medical Faculty
  • Izmir Medical Park Hospital - Medical Oncology
  • Kocaeli University Research and Practice Hospital
  • Necmettin Erbakan University Meram Medical Faculty
  • Inonu University Turgut Ozal Medical Center
  • Komunalna ustanova "Chernivets
  • Komunalnyi zaklad Miska bahato
  • Komunalne nekomertsiine pidpry
  • PE PMC "Acinus"
  • Medychnyi tsentr "Mriya Med-Servis"
  • Limited Liability Company "Medical Center "Verum"
  • Komunalne pidpryiemstvo "Volynskyi oblasnyi medychnyi tsentr onkolohii" Volynskoyi oblasnoyi rady
  • Medychnyi tsentr "Onkolaif" LL
  • Zaporozhye Regional Clinical O

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

HLX10 + chemotherapy (carboplatin nab paclitaxel)

Placebo + chemotherapy (carboplatin nab paclitaxel), After 1st PD, the subject will be unblinded by the investigator and be continued with HLX10 monotherapy

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
July 19, 2019
Last Updated
August 7, 2023
Sponsor
Shanghai Henlius Biotech
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1. Study Identification

Unique Protocol Identification Number
NCT04033354
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 14, 2019 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Henlius Biotech

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Non Small Cell Lung Cancer
Keywords
Locally Advanced or Metastatic, Squamous Non Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
537 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
HLX10 + chemotherapy (carboplatin nab paclitaxel)
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Placebo + chemotherapy (carboplatin nab paclitaxel), After 1st PD, the subject will be unblinded by the investigator and be continued with HLX10 monotherapy
Intervention Type
Drug
Intervention Name(s)
HLX10
Intervention Description
HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc.
Intervention Type
Drug
Intervention Name(s)
carboplatin and nab paclitaxel
Intervention Description
chemotherapeutics
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
tumor assessment
Description
Progression-free survival (PFS) (assessed by the independent radiology review committee [IRRC] based on Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)
Time Frame
Baseline until disease progression or death, whichever occurs first (up to approximately 24months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Oncology and Hematology Associates of Southwest Virginia
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Anhui Medical University - The Second Hospital
City
Hefei
State/Province
Anhui
Country
China
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
Country
China
Facility Name
The First Affiliated Hospital Of Anhui Medical University
City
Hefei
State/Province
Anhui
Country
China
Facility Name
The Second Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
Country
China
Facility Name
Beijing Chaoyang Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Beijing Friendship Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Daping Hospital
City
Chongqing
State/Province
Chongqing
Country
China
Facility Name
The Second Affiliated Hospital of Army Medical University,PLA
City
Chongqing
State/Province
Chongqing
Country
China
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
Country
China
Facility Name
Fujian Provincial Cancer Hospital
City
Fuzhou
State/Province
Fujian
Country
China
Facility Name
Fuzhou Pulmonary hospital of Fujian
City
Fuzhou
State/Province
Fujian
Country
China
Facility Name
Gansu Wuwei Tumour Hospital
City
Wuwei
State/Province
Gansu
Country
China
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
The Fifth Affiliared Hospital Sun Yat-Sen University
City
Zhuhai
State/Province
Guangdong
Country
China
Facility Name
Liuzhou People's Hospital
City
Liuzhou
State/Province
Guangxi
Country
China
Facility Name
Liuzhou Worker's Hospital
City
Liuzhou
State/Province
Guangxi
Country
China
Facility Name
Guangxi Medical University Affiliated Tumor Hospital
City
Nanning
State/Province
Guangxi
Country
China
Facility Name
The People's Hospital of Guangxi Zhuang Autonomous Region
City
Nanning
State/Province
Guangxi
Country
China
Facility Name
The Second Affiliated Hospital of Hainan Medical University
City
Haikou
State/Province
Hainan
Country
China
Facility Name
Affiliated Hospital of Hebei University
City
Baoding
State/Province
Hebei
Country
China
Facility Name
Cangzhou People's Hospital
City
Cangzhou
State/Province
Hebei
Country
China
Facility Name
Tangshan People's Hospital
City
Tangshan
State/Province
Hebei
Country
China
Facility Name
Harbin Medical University - Tumor Hospital (The Third Affiliated Hospital)
City
Ha'erbin
State/Province
Heilongjiang
Country
China
Facility Name
The fourth affiliated hospital of Harbin medical university
City
Ha'erbin
State/Province
Heilongjiang
Country
China
Facility Name
Jiamusi Cancer Hospital
City
Jiamusi
State/Province
Heilongjiang
Country
China
Facility Name
The Third Affiliated Hospital of Qiqihar Medical University
City
Qiqihar
State/Province
Heilongjiang
Country
China
Facility Name
The First Affiliated Hospital of Xinxiang Medical University
City
Xinxiang
State/Province
Henan
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Hubei Cancer Hospital
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
Country
China
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Xuzhou Central Hospital
City
Xuzhou
State/Province
Jiangsu
Country
China
Facility Name
the First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Name
China-japan union hospital of jilin university
City
Changchun
State/Province
Jilin
Country
China
Facility Name
Jilin Province Cancer Hospital
City
Changchun
State/Province
Jilin
Country
China
Facility Name
Jilin Province People's Hospital
City
Changchun
State/Province
Jilin
Country
China
Facility Name
The first hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Facility Name
The second Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Facility Name
Chifeng Municipal Hospital
City
Chifeng
State/Province
Neimenggu
Country
China
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
Country
China
Facility Name
Shandong Cancer Hospital - Internal Medicine
City
Jinan
State/Province
Shandong
Country
China
Facility Name
Linyi City People Hospital
City
Linyi
State/Province
Shandong
Country
China
Facility Name
Shandong Linyi Tumor Hospital
City
Linyi
State/Province
Shandong
Country
China
Facility Name
Shanghai Eastern Hospital /Affliated Eastern Hospital of Ton
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Tianjin Medical University Cancer Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
Yunnan cancer hospital
City
Kunming
State/Province
Yunnan
Country
China
Facility Name
Sir Run Run Shaw Hospital, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
The First Affiliated Hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
The Second Affiliated Hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
High Technology Hospital MedCenter LTD
City
Batumi
Country
Georgia
Facility Name
JSC Evex Clinics, St.Nikolozi Medical Centre
City
Kutaisi
Country
Georgia
Facility Name
Acad.F.Todua Medical Center - Research Institute of Clinical Medicine LTD
City
Tbilisi
Country
Georgia
Facility Name
Institute of Clinical Oncology LTD
City
Tbilisi
Country
Georgia
Facility Name
LTD Israeli-Georgian Medical Research Clinic HELSICORE
City
Tbilisi
Country
Georgia
Facility Name
Multiprofile Clinic Consilium Medula LTD
City
Tbilisi
Country
Georgia
Facility Name
New Hospitals LTD
City
Tbilisi
Country
Georgia
Facility Name
Scientific Research Center of Oncology LTD
City
Tbilisi
Country
Georgia
Facility Name
Uniwersytecki Szpital Kliniczny w Białymstoku
City
Białystok
Country
Poland
Facility Name
Wojew. Wielospecjalistyczne Centrum Onkologii i Traumatologi
City
Łódź
Country
Poland
Facility Name
LLC "VitaMed "
City
Moscow
Country
Russian Federation
Facility Name
University Clinic of Headaches
City
Moscow
Country
Russian Federation
Facility Name
Budgetary Healthcare Institution of Omsk Region "C
City
Omsk
Country
Russian Federation
Facility Name
GBUZ Orenburg Regional Clinical Oncology Dispensar
City
Orenburg
Country
Russian Federation
Facility Name
First St. Petersburg State Medical University n. a. Pavlov
City
Saint Petersburg
Country
Russian Federation
Facility Name
Limited Liability Company "AV Medical Group"
City
Saint Petersburg
Country
Russian Federation
Facility Name
LLC - Strategic Medical systems - Oncology - Oncology
City
Saint Petersburg
Country
Russian Federation
Facility Name
PMI "Evromedservice"
City
Saint Petersburg
Country
Russian Federation
Facility Name
Volgograd Regional Clinical Oncology Dispensary
City
Volgograd
Country
Russian Federation
Facility Name
Ankara University Medical Faculty - Oncology
City
Ankara
Country
Turkey
Facility Name
Hacettepe University Medical Faculty - Medical Oncology
City
Ankara
Country
Turkey
Facility Name
Trakya University Medical Faculty
City
Edirne
Country
Turkey
Facility Name
Istanbul University Cerrahpasa Medical Faculty
City
Istanbul
Country
Turkey
Facility Name
Medipol Mega Hospital
City
Istanbul
Country
Turkey
Facility Name
Ege University Medical Faculty
City
İzmir
Country
Turkey
Facility Name
Izmir Medical Park Hospital - Medical Oncology
City
İzmir
Country
Turkey
Facility Name
Kocaeli University Research and Practice Hospital
City
Kocaeli
Country
Turkey
Facility Name
Necmettin Erbakan University Meram Medical Faculty
City
Konya
Country
Turkey
Facility Name
Inonu University Turgut Ozal Medical Center
City
Malatya
Country
Turkey
Facility Name
Komunalna ustanova "Chernivets
City
Chernivtsi
Country
Ukraine
Facility Name
Komunalnyi zaklad Miska bahato
City
Dnipro
Country
Ukraine
Facility Name
Komunalne nekomertsiine pidpry
City
Kharkiv
Country
Ukraine
Facility Name
PE PMC "Acinus"
City
Kirovohrad
Country
Ukraine
Facility Name
Medychnyi tsentr "Mriya Med-Servis"
City
Kryvyi Rih
Country
Ukraine
Facility Name
Limited Liability Company "Medical Center "Verum"
City
Kyiv
Country
Ukraine
Facility Name
Komunalne pidpryiemstvo "Volynskyi oblasnyi medychnyi tsentr onkolohii" Volynskoyi oblasnoyi rady
City
Luts'k
Country
Ukraine
Facility Name
Medychnyi tsentr "Onkolaif" LL
City
Zaporizhzhia
Country
Ukraine
Facility Name
Zaporozhye Regional Clinical O
City
Zaporizhzhia
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this 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

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