A Study of SKB264 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
A Randomized, Open-Label, Multicenter Phase III Clinical Study of SKB264 in Combination With Pembrolizumab Versus Pembrolizumab as First-Line Treatment for PD-L1 Positive Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
1 other identifier
interventional
406
1 country
64
Brief Summary
The aim of the study is to evaluate the efficacy and safety of SKB264 in combination with pembrolizumab as firstline treatment for patients with PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).
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 Jun 2024
Shorter than P25 for phase_3 nonsmall-cell-lung-cancer
64 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2024
CompletedFirst Posted
Study publicly available on registry
June 7, 2024
CompletedStudy Start
First participant enrolled
June 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
May 8, 2026
May 1, 2026
2.4 years
June 3, 2024
May 5, 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 22months
Secondary Outcomes (11)
Overall Survival (OS)
Randomization up to approximately 40 months
Progression-Free Survival (PFS) assessed by Investigator
Randomization up to approximately 22months
Objective Response Rate (ORR)
Randomization up to approximately 22months
Disease control rate (DCR)
Randomization up to approximately 22months
Duration of Response (DoR)
Randomization up to approximately 22months
- +6 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
ACTIVE COMPARATORParticipants will receive Pembrolizumab on Day 1 of each 6-week cycle.
Interventions
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed NSCLC that is locally advanced (Stage ⅢB/ⅢC) or metastatic (Stage IV) NSCLC that is not amenable to radical surgery and/or radical radiotherapy regardless of concurrent chemotherapy.
- No prior systemic anti-cancer therapy for locally advanced or metastatic disease.
- 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:
- Active second malignancy.
- Uncontrolled or clinical significant cardiovascular disease.
- 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.
- Known allergy to SKB264 or pembrolizumab or any of its components.
- Prior treatment with any of the following (including in the context of adjuvant, neoadjuvant therapy):
- Immune checkpoint inhibitors (e.g., anti-PD-1/L1 antibody, anti-CTLA-4 antibody, etc.), checkpoint agonists (e.g., ICOS, CD40, CD137, GITR, OX40 antibody, etc.), any treatment targeting the immune mechanism of tumors such as immune cell therapy;
- Therapy targeting TROP2.
- Any drug therapy that targets topoisomerase I, including antibody-drug conjugates (ADCs).
- 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 (64)
Hebei University Affiliated Hospital
Baoding, China
Beijing Chest Hospital. Capital Medical University
Beijing, China
Beijing Institute for Cancer Research
Beijing, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Jilin Cancer Hospital
Changchun, China
The First Hospital of Jilin University
Changchun, China
Hunan Cancer Hospital
Changsha, China
The Second People's Hospital of Hunan Province（Brain Hospital of Hunan Province）
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
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 Southwest Hospital Of AMU
Chongqing, China
The Second Affiliated Hospital of Dalian Medical University
Dalian, China
Dongguan People's Hospital
Dongguan, China
Fujian Cancer Hospital
Fuzhou, China
Fujian Medical University Union Hospital
Fuzhou, China
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, China
Sun Yat-sen Memorial Hospital Sun Yat-sen University
Guangzhou, China
Sun Yat-sen University Cancer Center
Guangzhou, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, China
Sir Run Run Shaw Hospital (SRRSH)
Hangzhou, China
Zhejiang Cancer Hospital
Hangzhou, China
Harbin Medical University Cancer Hospital
Harbin, China
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, 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 Yunnan Cancer Hospital
Kunming, China
Gansu Provincial Cancer Hospital
Lanzhou, 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
Jiangsu Province Hospital
Nanjing, China
Guangxi Medical University Cancer Hospital
Nanning, China
People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, China
Shanghai Chest Hospital
Shanghai, China
Shanghai East Hospital, Tongji University
Shanghai, China
Shanghai Pulmonary Hospital
Shanghai, China
Zhongshan Hospital of Fudan University
Shanghai, China
Yuebei People's Hospital
Shaoguan, China
China Medical University First Affiliated Hospital
Shenyang, China
Liaoning Cancer Hospital
Shenyang, China
Shengjing Hospital, China Medical University
Shenyang, China
Shanxi Province Cancer Hospital
Taiyuan, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
Hubei Cancer Hospital
Wuhan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
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
Affiliated Tumor Hospital of Xinjiang Medical University
Xinjiang, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, China
Subei People's Hospital of Jiangsu province
Yangzhou, China
Yibin Second People's Hospital
Yibin, China
The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital，Henan Academy of Innovations in Medical Science
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)
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
June 3, 2024
First Posted
June 7, 2024
Study Start
June 7, 2024
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
May 8, 2026
Record last verified: 2026-05