Lung Cancer Clinical 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
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:
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.
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There is 1 Location for this study
Roanoke Virginia, 24014, United States
Hefei Anhui, , China
Hefei Anhui, , China
Hefei Anhui, , China
Hefei Anhui, , China
Beijing Beijing, , China
Beijing Beijing, , China
Beijing Beijing, , China
Chongqing Chongqing, , China
Chongqing Chongqing, , China
Fuzhou Fujian, , China
Fuzhou Fujian, , China
Fuzhou Fujian, , China
Wuwei Gansu, , China
Guangzhou Guangdong, , China
Zhuhai Guangdong, , China
Liuzhou Guangxi, , China
Liuzhou Guangxi, , China
Nanning Guangxi, , China
Nanning Guangxi, , China
Haikou Hainan, , China
Baoding Hebei, , China
Cangzhou Hebei, , China
Tangshan Hebei, , China
Ha'erbin Heilongjiang, , China
Ha'erbin Heilongjiang, , China
Jiamusi Heilongjiang, , China
Qiqihar Heilongjiang, , China
Xinxiang Henan, , China
Zhengzhou Henan, , China
Wuhan Hubei, , China
Changsha Hunan, , China
Changsha Hunan, , China
Xuzhou Jiangsu, , China
Nanchang Jiangxi, , China
Changchun Jilin, , China
Changchun Jilin, , China
Changchun Jilin, , China
Changchun Jilin, , China
Changchun Jilin, , China
Chifeng Neimenggu, , China
Yinchuan Ningxia, , China
Jinan Shandong, , China
Linyi Shandong, , China
Linyi Shandong, , China
Shanghai Shanghai, , China
Shanghai Shanghai, , China
Chengdu Sichuan, , China
Tianjin Tianjin, , China
Tianjin Tianjin, , China
Kunming Yunnan, , China
Hangzhou Zhejiang, , China
Hangzhou Zhejiang, , China
Hangzhou Zhejiang, , China
Batumi , , Georgia
Kutaisi , , Georgia
Tbilisi , , Georgia
Tbilisi , , Georgia
Tbilisi , , Georgia
Tbilisi , , Georgia
Tbilisi , , Georgia
Tbilisi , , Georgia
Białystok , , Poland
Åódź , , Poland
Moscow , , Russian Federation
Moscow , , Russian Federation
Omsk , , Russian Federation
Orenburg , , Russian Federation
Saint Petersburg , , Russian Federation
Saint Petersburg , , Russian Federation
Saint Petersburg , , Russian Federation
Saint Petersburg , , Russian Federation
Volgograd , , Russian Federation
Ankara , , Turkey
Ankara , , Turkey
Edirne , , Turkey
Istanbul , , Turkey
Istanbul , , Turkey
Ä°zmir , , Turkey
Ä°zmir , , Turkey
Kocaeli , , Turkey
Konya , , Turkey
Malatya , , Turkey
Chernivtsi , , Ukraine
Dnipro , , Ukraine
Kharkiv , , Ukraine
Kirovohrad , , Ukraine
Kryvyi Rih , , Ukraine
Kyiv , , Ukraine
Luts'k , , Ukraine
Zaporizhzhia , , Ukraine
Zaporizhzhia , , Ukraine
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