A Study of SKB264 in Combination With Pembrolizumab Versus Chemotherapy in Combination With Pembrolizumab as First-Line Treatment for PD-L1 Negative Patients With Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
A Randomized, Open-Label, Multicenter Phase 3 Clinical Study of SKB264 in Combination With Pembrolizumab Versus Chemotherapy in Combination With Pembrolizumab as First-Line Treatment for PD-L1 Negative Patients With Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
1 other identifier
interventional
432
1 country
81
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 nonsmall-cell-lung-cancer
Started Oct 2024
81 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 30, 2024
CompletedFirst Submitted
Initial submission to the registry
November 22, 2024
CompletedFirst Posted
Study publicly available on registry
December 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
July 8, 2026
May 1, 2026
2.1 years
November 22, 2024
July 6, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (12)
Overall Survival (OS)
Randomization up to approximately 43 months
Progression-Free Survival (PFS) assessed by Investigator
Randomization up to approximately 28 months
Objective Response Rate (ORR)
Randomization up to approximately 28 months
Disease control rate (DCR)
Randomization up to approximately 28 months
Duration of Response (DoR)
Randomization up to approximately 28 months
- +7 more secondary outcomes
Study Arms (2)
SKB264+Pembrolizumab
EXPERIMENTALParticipants 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 COMPARATORParticipants will receive Pembrolizumab on Day1 of each 6-week cycle,Chemotherapy on Day1 and Day 22 of each 6-week
Interventions
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed non-squamous NSCLC, and unsuitable for radical surgery and/or radical concurrent/sequential radiochemotherapy, locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) NSCLC;
- EGFR-sensitive mutation negative \[no exon 19 deletion (19-Del) or exon 21 point mutation (L858R mutation)\] and ALK fusion gene negative, without known ROS1 gene fusion, NTRK gene fusion, BRAF V600E mutation, etc. that have been approved for targeted therapy driving gene alterations;
- No prior systemic anti-cancer therapy for locally advanced or metastatic NSCLC;
- Participants whose tumours are PD-L1 TPS \< 1%;
- At least one measurable lesion per RECIST v1.1;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no worsening within 7 days prior to randomization;
- A life expectancy of at least 12 weeks;
- Adequate organ and bone marrow function;
You may not qualify if:
- Histologically or cytologically confirmed tumors with a component of small cell lung cancer, neuroendocrine carcinoma, sarcomatoid carcinoma, or squamous cell carcinoma exceeding 10%;
- Previously received immune checkpoint inhibitors,checkpoint agonists or any treatment targeting the immune mechanism of tumors such as immune cell therapy;
- Active second malignancy;
- Symptomatic or uncontrolled cardiovascular disease，serious thromboembolic；
- History of noninfectious pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD;
- Active infection requiring systemic therapy within 2 weeks of randomization;
- Active hepatitis B or hepatitis C virus infection;
- Human immunodeficiency virus (HIV) positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection;
- Major surgery within 4 weeks prior to randomization or expected major surgery during the study;
- Pregnant or lactating women;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (81)
Beijing Cancer Hospital
Beijing, China
Beijing Chest Hospital. Capital Medical University
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2024
First Posted
December 2, 2024
Study Start
October 30, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2028
Last Updated
July 8, 2026
Record last verified: 2026-05