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The study aims to evaluate the efficacy and safety of SKB264 in combination with pembrolizumab versus chemotherapy in combination with pembrolizumab in the first-line treatment of patients with locally advanced or metastatic non-squamous NSCLC with PD-L1 negative.
This is a randomized, open-label, multicenter, Phase 3 study to evaluate the efficacy and safety of SKB264 in combination with pembrolizumab versus chemotherapy in combination with pembrolizumab in the first-line treatment of patients with locally advanced or metastatic non-squamous NSCLC with PD-L1 negative.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SKB264+Pembrolizumab | Experimental | Participants will receive SKB264 on Day 1、Day 15 and Day 29 of each 6-week cycle,Pembrolizumab on Day1 of each 6-week cycle. |
|
| Pembrolizumab+Chemotherapy | Active Comparator | Participants will receive Pembrolizumab on Day1 of each 6-week cycle,Chemotherapy on Day1 and Day 22 of each 6-week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SKB264 | Drug | IV Infusion |
| |
| Pembrolizumab |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) | PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first. | Randomization up to approximately 28 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the time from randomization until the date of death due to any cause. | Randomization up to approximately 43 months |
| Progression-Free Survival (PFS) assessed by Investigator |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | China | ||||
| Beijing Chest Hospital. Capital Medical University |
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Participants will be randomised in a 1:1 ratio to one of two intervention groups.
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| Drug |
IV Infusion |
|
| pemetrexed | Drug | IV Infusion |
|
| carboplatin or cisplatin | Drug | IV Infusion |
|
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator or death due to any cause, whichever occurs first.
| Randomization up to approximately 28 months |
| Objective Response Rate (ORR) | ORR is defined as the percentage of patients who achieve complete response(CR) or partial response (PR), as assessed by BICR/investigator per RECIST 1.1 | Randomization up to approximately 28 months |
| Disease control rate (DCR) | DCR is defined as the percentage of patients who achieve CR, PR or stable disease (SD), as assessed by BICR/ investigator per RECIST 1.1 | Randomization up to approximately 28 months |
| Duration of Response (DoR) | DoR is defined as the time from the date of first documented CR or PR until date of documented disease progression per RECIST 1.1, as assessed by BICR/investigator or death due to any cause, whichever occurs first. | Randomization up to approximately 28 months |
| Time to Response (TTR) | TTR is defined as the time from the date of randomization until the first documentation of CR or PR as assessed by BICR/investigator per RECIST 1.1. | Randomization up to approximately 28 months |
| AEs and SAEs | Incidence and severity of AEs and SAEs (per CTCAE v5.0), and clinically significant abnormal laboratory results | All AEs should be observed and recorded from the first dose until 30 days after the last dose. SAEs were observed and recorded until 90 days after the last dose of pembrolizumab or 30 days after the last dose of SKB264,whichever occurred later. |
| Health-Related Quality of Life Assessed by EORTC QLQ-C30 | The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) is used to assess participants's health-related quality of life. The scale covers functional domains, symptom domains, and overall health status/total quality of life domain. All domain scores are standardized to a range of 0 to 100. For functional domains and overall health status/total quality of life, higher scores indicate better functional status and quality of life; for symptom domains, higher scores indicate more symptoms or problems (worse quality of life). This study will compare changes from baseline in quality-of-life scores across all dimensions, analyze time to deterioration in general health status, symptoms and function, and summarize the number and percentage of participants with clinically meaningful changes post-baseline. | Randomization up to approximately 28months |
| Lung Cancer-Related Symptoms Assessed by EORTC QLQ-LC13 Symptom Domain | The symptom domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) is used to assess lung cancer-related symptoms and treatment-related symptoms. The scale includes both multiple-item and single-item measurement parameters. Scores are standardized to a range of 0 to 100. Higher scores indicate more severe symptoms (worse outcome). This study will compare changes from baseline in symptom scores, analyze time to deterioration of cancer-related symptoms, and summarize the number and percentage of participants with clinically meaningful changes post-baseline. | From randomization up to approximately 28 months |
| PK | PK parameters of SKB264-ADC, SKB264-TAB and free KL610023, such as maximum concentration (Cmax), minimum concentration (Cmin ), etc. | Randomization up to approximately 28months |
| Immunogenicity | Anti-drug antibody (ADA) of SKB264 in the serum of subjects will be determined using MSD-based Bridging-ECLA. | Randomization up to approximately 28months |
| Biomarkers | Correlation between the expression level of TROP2 in tumor tissues and the efficacy. | Tumor tissue samples should be provided for TROP2 testing after subjects are eligible for screening. |
| Beijing |
| China |
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | China |
| Peking University Third Hospital | Beijing | China |
| The First Hospital of Jilin University | Changchun | China |
| Jilin Cancer Hospital | Changcun | China |
| Hunan Cancer Hospital | Changsha | China |
| Xiangya Hospital, Central South University | Changsha | China |
| Xiangya Second Hospital of Central South University | Changsha | China |
| Chengdu Fifth People's Hospital | Chengdu | China |
| Sichuan Provincial People's Hospital | Chengdu | China |
| The General Hospital of Western Theater Command | Chengdu | China |
| University of Electronic Science and Technology of China, Sichuan Cancer Hospital and Institute & Cancer, The Second People's Hospital of Sichuan Province | Chengdu | China |
| West China Hospital of Sichuan University | Chengdu | China |
| Army Medical Center of PLA (Daping Hospital) | Chongqing | China |
| Chongqing University Cancer Hospital | Chongqing | China |
| The Second Affiliated Hospital of Army Medical University | Chongqing | China |
| The Southwest Hospial Of AMU | Chongqing | China |
| The Second Affiliated Hospital of Dalian Medical University | Dalian | China |
| Fujian Cancer Hospital | Fuzhou | China |
| The 900 Hospital of the Joint Logistics Support Force of the People's Liberation Army of China | Fuzhou | China |
| First Affiliated Hospital of Gannan Medical University | Ganzhou | China |
| Affiliated Cancer Hospital and Institute of Guangzhou Medical University | Guangzhou | China |
| Sun Yat-sen University Cancer Center | Guangzhou | China |
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | China |
| Affiliated Hospital of Guilin Medical University | Guilin | China |
| Sir Run Run Shaw Hospital (SRRSH) | Hangzhou | China |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | China |
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | China |
| Zhejiang Cancer Hospital | Hangzhou | China |
| Harbin Medical University Cancer Hospital | Ha’erbin | China |
| The 2nd Affiliated Hospital of Harbin Medical University | Ha’erbin | China |
| Anhui Provincial Chest Hospital | Hefei | China |
| The Second Affiliated Hospital Of Anhui Medical University | Hefei | China |
| Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences | Jinan | China |
| Shandong Provincial Hospital | Jinan | China |
| The Third Affiliated Hospital of Kunming Medical University | Kunming | China |
| Gansu Provincial Cancer Hospital | Lanzhou | China |
| Linyi Cancer Hospital | Linyi | China |
| The First Affiliated Hospital of Henan University of Science & Technology, | Luoyang | China |
| Mianyang Central Hospital, School of Medicine, University of Electronic Science and Technology of China | Mianyang | China |
| Jiangxi Cancer Hospital | Nanchang | China |
| The First Affiliated Hospital of Nanchang University | Nanchang | China |
| Affiliated Hospital of North Sichuan Medical College | Nanchong | China |
| Jiangsu Cancer Hospital | Nanjing | China |
| Jiangsu Province Hospital | Nanjing | China |
| Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School | Nanjing | China |
| Guangxi Medical University Cancer Hospital | Nanning | China |
| People's Hospital of Guangxi Zhuang Autonomous Region | Nanning | China |
| The First Affiliated Hospital of Guangxi Medical University | Nanning | China |
| The Second People's Hospital of Neijiang | Neijiang | China |
| The Affiliated Hospital of Qingdao University | Qingdao | China |
| Huashan Hospital Affiliated to Fudan University | Shanghai | China |
| Shanghai Chest Hospital | Shanghai | China |
| Shanghai Oriental Hospital | Shanghai | China |
| Shanghai Pulmonary Hospital | Shanghai | China |
| Zhongshan Hospital of Fudan University | Shanghai | China |
| Yuebei People's Hospital | Shaoguan | China |
| Shengjing Hospital, China Medical University | Shengyang | China |
| China Medical University First Affiliated Hospital | Shenyang | China |
| Liaoning Cancer Hospital | Shenyang | China |
| The Fourth Hospital of Hebei Medical University | Shijiazhuang | China |
| Shanxi Province Cancer Hospital | Taiyuan | China |
| Taizhou Hospital of Zhejiang Province | Taizhou | China |
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | China |
| Affiliated Tumor Hospital of Xinjiang Medical University | Ürümqi | China |
| Weifang People's Hospital | Weifang | China |
| Hubei Cancer Hospital | Wuhan | China |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | China |
| Zhongnan Hospital of Wuhan University | Wuhan | China |
| The First Affiliated Hospital of XiAn Jiaotong University | Xi'an | China |
| The Second Affiliated Hospital of XiAn Jiaotong University | Xi'an | China |
| The First Affiliated Hospital Of Xiamen University | Xiamen | China |
| Xiangyang Central Hospital | Xiangyang | China |
| The First Affiliated Hospital of Xinxiang Medical University | Xinxiang | China |
| Yibin Second People's Hospital | Yibin | China |
| General Hospital of Ningxia Medical University | Yinchuan | China |
| Henan Cancer Hospital | Zhengzhou | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | China |
| The Second Affiliated Hospital Of Zunyi Medical University | Zunyi | China |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D000068437 | Pemetrexed |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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