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

Squamous Non Small Cell Lung Cancer Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04033354
• Other study ID #: HLX10-004-NSCLC303
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 14, 2019
• Est. completion date: December 30, 2023

Study information

• Verified date: August 2023
• Source: Shanghai Henlius Biotech
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 537
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Squamous Non Small Cell Lung Cancer

Intervention

Drug:
• HLX10
HLX10 is an innovative monoclonal antibody targeting PD-1,developed by Shanghai Henlius Biotech, Inc.
• carboplatin and nab paclitaxel
chemotherapeutics
• Placebo
Placebo

Locations

Country	Name	City	State
China	Affiliated Hospital of Hebei University	Baoding	Hebei
China	Beijing Chaoyang Hospital	Beijing	Beijing
China	Beijing Friendship Hospital	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Cangzhou People's Hospital	Cangzhou	Hebei
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	Hunan Cancer Hospital	Changsha	Hunan
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	Chifeng Municipal Hospital	Chifeng	Neimenggu
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	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
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	The Second Affiliated Hospital of Hainan Medical University	Haikou	Hainan
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	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	Jiamusi Cancer Hospital	Jiamusi	Heilongjiang
China	Shandong Cancer Hospital - Internal Medicine	Jinan	Shandong
China	Yunnan cancer hospital	Kunming	Yunnan
China	Linyi City People Hospital	Linyi	Shandong
China	Shandong Linyi Tumor Hospital	Linyi	Shandong
China	Liuzhou People's Hospital	Liuzhou	Guangxi
China	Liuzhou Worker's Hospital	Liuzhou	Guangxi
China	the First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Guangxi Medical University Affiliated Tumor Hospital	Nanning	Guangxi
China	The People's Hospital of Guangxi Zhuang Autonomous Region	Nanning	Guangxi
China	The Third Affiliated Hospital of Qiqihar Medical University	Qiqihar	Heilongjiang
China	Shanghai Eastern Hospital /Affliated Eastern Hospital of Ton	Shanghai	Shanghai
China	Shanghai Pulmonary Hospital	Shanghai	Shanghai
China	Tangshan People's Hospital	Tangshan	Hebei
China	Tianjin Medical University Cancer Hospital	Tianjin	Tianjin
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	Hubei Cancer Hospital	Wuhan	Hubei
China	Gansu Wuwei Tumour Hospital	Wuwei	Gansu
China	The First Affiliated Hospital of Xinxiang Medical University	Xinxiang	Henan
China	Xuzhou Central Hospital	Xuzhou	Jiangsu
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia
China	Henan Cancer Hospital	Zhengzhou	Henan
China	The Fifth Affiliared Hospital Sun Yat-Sen University	Zhuhai	Guangdong
Georgia	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
Poland	Uniwersytecki Szpital Kliniczny w Bialymstoku	Bialystok
Poland	Wojew. Wielospecjalistyczne Centrum Onkologii i Traumatologi	Lódz
Russian Federation	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
Turkey	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	Izmir
Turkey	Izmir Medical Park Hospital - Medical Oncology	Izmir
Turkey	Kocaeli University Research and Practice Hospital	Kocaeli
Turkey	Necmettin Erbakan University Meram Medical Faculty	Konya
Turkey	Inonu University Turgut Ozal Medical Center	Malatya
Ukraine	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
United States	Oncology and Hematology Associates of Southwest Virginia	Roanoke	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Henlius Biotech

Countries where clinical trial is conducted

United States,  China,  Georgia,  Poland,  Russian Federation,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Baseline until disease progression or death, whichever occurs first (up to approximately 24months)