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

August 7, 2023 updated by: Shanghai Henlius Biotech

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)

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

537

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • Anhui Provincial Hospital
      • Hefei, Anhui, China
        • The First Affiliated Hospital of Anhui Medical University
      • Hefei, Anhui, China
        • Anhui Medical University - The Second Hospital
      • Hefei, Anhui, China
        • The Second Affiliated Hospital of Anhui Medical University
    • Beijing
      • Beijing, Beijing, China
        • Peking University First Hospital
      • Beijing, Beijing, China
        • Beijing ChaoYang Hospital
      • Beijing, Beijing, China
        • Beijing Friendship Hospital
    • Chongqing
      • Chongqing, Chongqing, China
        • Daping Hospital
      • Chongqing, Chongqing, China
        • The Second Affiliated Hospital of Army Medical University,PLA
    • Fujian
      • Fuzhou, Fujian, China
        • Fujian Medical University Union Hospital
      • Fuzhou, Fujian, China
        • Fujian Provincial Cancer Hospital
      • Fuzhou, Fujian, China
        • Fuzhou Pulmonary Hospital of Fujian
    • Gansu
      • Wuwei, Gansu, China
        • Gansu Wuwei Tumour Hospital
    • Guangdong
      • Guangzhou, Guangdong, China
        • The First Affiliated Hospital of Guangzhou Medical University
      • Zhuhai, Guangdong, China
        • The Fifth Affiliared Hospital Sun Yat-Sen University
    • Guangxi
      • Liuzhou, Guangxi, China
        • Liuzhou People's Hospital
      • Liuzhou, Guangxi, China
        • Liuzhou Worker's Hospital
      • Nanning, Guangxi, China
        • The people's hospital of Guangxi Zhuang Autonomous Region
      • Nanning, Guangxi, China
        • Guangxi Medical University Affiliated Tumor Hospital
    • Hainan
      • Haikou, Hainan, China
        • The Second Affiliated Hospital of Hainan Medical University
    • Hebei
      • Baoding, Hebei, China
        • Affiliated Hospital of Hebei University
      • Cangzhou, Hebei, China
        • Cangzhou People's Hospital
      • Tangshan, Hebei, China
        • Tangshan People's Hospital
    • Heilongjiang
      • Ha'erbin, Heilongjiang, China
        • Harbin Medical University - Tumor Hospital (The Third Affiliated Hospital)
      • Ha'erbin, Heilongjiang, China
        • The Fourth Affiliated Hospital of Harbin Medical University
      • Jiamusi, Heilongjiang, China
        • Jiamusi Cancer Hospital
      • Qiqihar, Heilongjiang, China
        • The Third Affiliated Hospital of Qiqihar Medical University
    • Henan
      • Xinxiang, Henan, China
        • The First Affiliated Hospital of Xinxiang Medical University
      • Zhengzhou, Henan, China
        • Henan Cancer Hospital
    • Hubei
      • Wuhan, Hubei, China
        • Hubei Cancer Hospital
    • Hunan
      • Changsha, Hunan, China
        • Hunan Cancer Hospital
      • Changsha, Hunan, China
        • The Third Xiangya Hospital of Central South University
    • Jiangsu
      • Xuzhou, Jiangsu, China
        • XuZhou Central Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China
        • The first affiliated Hospital of Nanchang University
    • Jilin
      • Changchun, Jilin, China
        • The First Hospital of Jilin University
      • Changchun, Jilin, China
        • The Second Hospital of Jilin University
      • Changchun, Jilin, China
        • Jilin Province People's Hospital
      • Changchun, Jilin, China
        • China-Japan Union Hospital of Jilin University
      • Changchun, Jilin, China
        • Jilin Province Cancer Hospital
    • Neimenggu
      • Chifeng, Neimenggu, China
        • Chifeng Municipal Hospital
    • Ningxia
      • Yinchuan, Ningxia, China
        • General Hospital of Ningxia Medical University
    • Shandong
      • Jinan, Shandong, China
        • Shandong Cancer Hospital - Internal Medicine
      • Linyi, Shandong, China
        • Linyi City People Hospital
      • Linyi, Shandong, China
        • Shandong Linyi Tumor Hospital
    • Shanghai
      • Shanghai, Shanghai, China
        • Shanghai Pulmonary Hospital
      • Shanghai, Shanghai, China
        • Shanghai Eastern Hospital /Affliated Eastern Hospital of Ton
    • Sichuan
      • Chengdu, Sichuan, China
        • West China Hospital, Sichuan University
    • Tianjin
      • Tianjin, Tianjin, China
        • Tianjin Medical University General Hospital
      • Tianjin, Tianjin, China
        • Tianjin Medical University Cancer Hospital
    • Yunnan
      • Kunming, Yunnan, China
        • Yunnan cancer hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • The Second Affiliated Hospital of Zhejiang University
      • Hangzhou, Zhejiang, China
        • The First Affiliated Hospital of Zhejiang University
      • Hangzhou, Zhejiang, China
        • Sir Run Run Shaw Hospital, Zhejiang University
  • Georgia
      • Batumi, Georgia
        • High Technology Hospital MedCenter Ltd
      • Kutaisi, Georgia
        • JSC Evex Clinics, St.Nikolozi Medical Centre
      • Tbilisi, 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
  • Poland
      • Białystok, Poland
        • Uniwersytecki Szpital Kliniczny w Białymstoku
      • Łódź, Poland
        • Wojew. Wielospecjalistyczne Centrum Onkologii i Traumatologi
  • Russian Federation
      • Moscow, Russian Federation
        • LLC "VitaMed "
      • Moscow, Russian Federation
        • University Clinic of Headaches
      • Omsk, Russian Federation
        • Budgetary Healthcare Institution of Omsk Region "C
      • Orenburg, Russian Federation
        • GBUZ Orenburg Regional Clinical Oncology Dispensar
      • Saint Petersburg, 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"
      • Volgograd, Russian Federation
        • Volgograd regional clinical oncology dispensary
  • Turkey
      • Ankara, Turkey
        • Ankara University Medical Faculty - Oncology
      • Ankara, Turkey
        • Hacettepe University Medical Faculty - Medical Oncology
      • Edirne, Turkey
        • Trakya University Medical Faculty
      • Istanbul, Turkey
        • Istanbul University Cerrahpasa Medical Faculty
      • Istanbul, Turkey
        • Medipol Mega Hospital
      • Kocaeli, Turkey
        • Kocaeli University Research and Practice Hospital
      • Konya, Turkey
        • Necmettin Erbakan University Meram Medical Faculty
      • Malatya, Turkey
        • Inonu University Turgut Ozal Medical Center
      • İzmir, Turkey
        • Ege University Medical Faculty
      • İzmir, Turkey
        • Izmir Medical Park Hospital - Medical Oncology
  • Ukraine
      • Chernivtsi, Ukraine
        • Komunalna ustanova "Chernivets
      • Dnipro, Ukraine
        • Komunalnyi zaklad Miska bahato
      • Kharkiv, Ukraine
        • Komunalne nekomertsiine pidpry
      • Kirovohrad, Ukraine
        • PE PMC "Acinus"
      • Kryvyi Rih, Ukraine
        • Medychnyi tsentr "Mriya Med-Servis"
      • Kyiv, Ukraine
        • Limited Liability Company "Medical Center "Verum"
      • Luts'k, Ukraine
        • Komunalne pidpryiemstvo "Volynskyi oblasnyi medychnyi tsentr onkolohii" Volynskoyi oblasnoyi rady
      • Zaporizhzhia, Ukraine
        • Medychnyi tsentr "Onkolaif" LL
      • Zaporizhzhia, Ukraine
        • Zaporozhye Regional Clinical O
  • United States
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • Oncology and Hematology Associates of Southwest Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
HLX10 + chemotherapy (carboplatin nab paclitaxel)
Drug: HLX10
HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc.
Drug: carboplatin and nab paclitaxel
chemotherapeutics
Placebo Comparator: B
Placebo + chemotherapy (carboplatin nab paclitaxel), After 1st PD, the subject will be unblinded by the investigator and be continued with HLX10 monotherapy
Drug: Placebo
Placebo
Drug: carboplatin and nab paclitaxel
chemotherapeutics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tumor assessment
Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 24months)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Henlius Biotech

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2019

Primary Completion (Estimated)

December 30, 2023

Study Completion (Estimated)

December 30, 2023

Study Registration Dates

First Submitted

July 19, 2019

First Submitted That Met QC Criteria

July 24, 2019

First Posted (Actual)

July 26, 2019

Study Record Updates

Last Update Posted (Actual)

August 8, 2023

Last Update Submitted That Met QC Criteria

August 7, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HLX10-004-NSCLC303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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