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AzTrials

Squamous Non Small Cell Lung CancerPhase 3NCT04033354

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

A Phase 3 study testing HLX10 and carboplatin and nab paclitaxel in people with Squamous Non Small Cell Lung Cancer, run by Shanghai Henlius Biotech at 92 sites in 7 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Squamous Non Small Cell Lung Cancer
What is being tested?
HLX10 and carboplatin and nab paclitaxel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
537 participants
Where
92 sitesin 7 countries
Study dates
14 Aug 2019to 30 Dec 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

92 sites in 7 countries.

92 sites in 7 countries

China53 sites

  • Affiliated Hospital of Hebei University

    Baoding, Hebei

  • Beijing Chaoyang Hospital

    Beijing, Beijing Municipality

  • Beijing Friendship Hospital

    Beijing, Beijing Municipality

  • Peking University First Hospital

    Beijing, Beijing Municipality

  • Cangzhou People's Hospital

    Cangzhou, Hebei

  • China-japan union hospital of jilin university

    Changchun, Jilin

  • Jilin Province Cancer Hospital

    Changchun, Jilin

  • Jilin Province People's Hospital

    Changchun, Jilin

  • The first hospital of Jilin University

    Changchun, Jilin

  • The second Hospital of Jilin University

    Changchun, Jilin

  • Hunan Cancer Hospital

    Changsha, Hunan

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan

  • West China Hospital, Sichuan University

    Chengdu, Sichuan

  • Chifeng Municipal Hospital

    Chifeng, Neimenggu

  • Daping Hospital

    Chongqing, Chongqing Municipality

  • The Second Affiliated Hospital of Army Medical University,PLA

    Chongqing, Chongqing Municipality

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian

  • Fujian Provincial Cancer Hospital

    Fuzhou, Fujian

  • Fuzhou Pulmonary hospital of Fujian

    Fuzhou, Fujian

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong

  • The Second Affiliated Hospital of Hainan Medical University

    Haikou, Hainan

  • Sir Run Run Shaw Hospital, Zhejiang University

    Hangzhou, Zhejiang

  • The First Affiliated Hospital of Zhejiang University

    Hangzhou, Zhejiang

  • The Second Affiliated Hospital of Zhejiang University

    Hangzhou, Zhejiang

  • Harbin Medical University - Tumor Hospital (The Third Affiliated Hospital)

    Harbin, Heilongjiang

  • The fourth affiliated hospital of Harbin medical university

    Harbin, Heilongjiang

  • Anhui Medical University - The Second Hospital

    Hefei, Anhui

  • Anhui Provincial Hospital

    Hefei, Anhui

  • The First Affiliated Hospital Of Anhui Medical University

    Hefei, Anhui

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

  • Jiamusi Cancer Hospital

    Jiamusi, Heilongjiang

  • Shandong Cancer Hospital - Internal Medicine

    Jinan, Shandong

  • Yunnan cancer hospital

    Kunming, Yunnan

  • Linyi City People Hospital

    Linyi, Shandong

  • Shandong Linyi Tumor Hospital

    Linyi, Shandong

  • Liuzhou People's Hospital

    Liuzhou, Guangxi

  • Liuzhou Worker's Hospital

    Liuzhou, Guangxi

  • the First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • Guangxi Medical University Affiliated Tumor Hospital

    Nanning, Guangxi

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi

  • The Third Affiliated Hospital of Qiqihar Medical University

    Qiqihar, Heilongjiang

  • Shanghai Eastern Hospital /Affliated Eastern Hospital of Ton

    Shanghai, Shanghai Municipality

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality

  • Tangshan People's Hospital

    Tangshan, Hebei

  • Tianjin Medical University Cancer Hospital

    Tianjin, Tianjin Municipality

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality

  • Hubei Cancer Hospital

    Wuhan, Hubei

  • Gansu Wuwei Tumour Hospital

    Wuwei, Gansu

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia

  • Henan Cancer Hospital

    Zhengzhou, Henan

  • The Fifth Affiliared Hospital Sun Yat-Sen University

    Zhuhai, Guangdong

Other trials in China

Turkey (Türkiye)10 sites

  • Ankara University Medical Faculty - Oncology

    Ankara

  • Hacettepe University Medical Faculty - Medical Oncology

    Ankara

  • Trakya University Medical Faculty

    Edirne

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul

  • Medipol Mega Hospital

    Istanbul

  • Ege University Medical Faculty

    Izmir

  • Izmir Medical Park Hospital - Medical Oncology

    Izmir

  • Kocaeli University Research and Practice Hospital

    Kocaeli

  • Necmettin Erbakan University Meram Medical Faculty

    Konya

  • Inonu University Turgut Ozal Medical Center

    Malatya

Other trials in Turkey (Türkiye)

Russia9 sites

  • LLC "VitaMed "

    Moscow

  • University Clinic of Headaches

    Moscow

  • Budgetary Healthcare Institution of Omsk Region "C

    Omsk

  • GBUZ Orenburg Regional Clinical Oncology Dispensar

    Orenburg

  • First St. Petersburg State Medical University n. a. Pavlov

    Saint Petersburg

  • Limited Liability Company "AV Medical Group"

    Saint Petersburg

  • LLC - Strategic Medical systems - Oncology - Oncology

    Saint Petersburg

  • PMI "Evromedservice"

    Saint Petersburg

  • Volgograd Regional Clinical Oncology Dispensary

    Volgograd

Other trials in Russia

Ukraine9 sites

  • Komunalna ustanova "Chernivets

    Chernivtsi

  • Komunalnyi zaklad Miska bahato

    Dnipro

  • Komunalne nekomertsiine pidpry

    Kharkiv

  • PE PMC "Acinus"

    Kirovohrad

  • Medychnyi tsentr "Mriya Med-Servis"

    Kryvyi Rih

  • Limited Liability Company "Medical Center "Verum"

    Kyiv

  • Komunalne pidpryiemstvo "Volynskyi oblasnyi medychnyi tsentr onkolohii" Volynskoyi oblasnoyi rady

    Lutsk

  • Medychnyi tsentr "Onkolaif" LL

    Zaporizhzhya

  • Zaporozhye Regional Clinical O

    Zaporizhzhya

Other trials in Ukraine

Georgia8 sites

  • High Technology Hospital MedCenter LTD

    Batumi

  • JSC Evex Clinics, St.Nikolozi Medical Centre

    Kutaisi

  • Acad.F.Todua Medical Center - Research Institute of Clinical Medicine LTD

    Tbilisi

  • Institute of Clinical Oncology LTD

    Tbilisi

  • LTD Israeli-Georgian Medical Research Clinic HELSICORE

    Tbilisi

  • Multiprofile Clinic Consilium Medula LTD

    Tbilisi

  • New Hospitals LTD

    Tbilisi

  • Scientific Research Center of Oncology LTD

    Tbilisi

Other trials in Georgia

Poland2 sites

  • Uniwersytecki Szpital Kliniczny w Białymstoku

    Bialystok

  • Wojew. Wielospecjalistyczne Centrum Onkologii i Traumatologi

    Lodz

Other trials in Poland

United States1 site

  • Oncology and Hematology Associates of Southwest Virginia

    Roanoke, Virginia, 24014

Other trials in United States

About this study

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)

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).

Being tested
HLX10, carboplatin and nab paclitaxel, Placebo
Keywords
Locally Advanced or Metastatic, Squamous Non Small Cell Lung Cancer
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HLX10Drug

    HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc.

  • carboplatin and nab paclitaxelDrug

    chemotherapeutics

  • PlaceboDrug

    Placebo

Study groups in NCT04033354
Study groupRoleWhat they receive
AExperimentalHLX10 + chemotherapy (carboplatin nab paclitaxel)
Receives: Drug: HLX10; Drug: carboplatin and nab paclitaxel
BPlacebo comparatorPlacebo + chemotherapy (carboplatin nab paclitaxel), After 1st PD, the subject will be unblinded by the investigator and be continued with HLX10 monotherapy
Receives: Drug: carboplatin and nab paclitaxel; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Baseline until disease progression or death, whichever occurs first (up to approximately 24months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2019
  2. Study start14 Aug 2019
  3. Primary completion30 Dec 2023 (estimated)
  4. Study completion30 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
537 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04033354
Sponsor's protocol ID
HLX10-004-NSCLC303
Status last verified
Aug 2023
First submitted
19 Jul 2019
Last updated
8 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38181795

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HLX10 and carboplatin and nab paclitaxel in people with Squamous Non Small Cell Lung Cancer, run by Shanghai Henlius Biotech at 92 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in China, Turkey (Türkiye), Russia, Ukraine, Georgia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

tumor assessment (time frame: Baseline until disease progression or death, whichever occurs first (up to approximately 24months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04033354, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.

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