A Study of SKB264 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
NCT ID: NCT06448312
Last Updated: 2025-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
406 participants
INTERVENTIONAL
2024-06-07
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SKB264+Pembrolizumab
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.
SKB264
IV Infusion
Pembrolizumab
IV Infusion
Pembrolizumab
Participants will receive Pembrolizumab on Day 1 of each 6-week cycle.
Pembrolizumab
IV Infusion
Interventions
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SKB264
IV Infusion
Pembrolizumab
IV Infusion
Eligibility Criteria
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Inclusion Criteria
2. No prior systemic anti-cancer therapy for locally advanced or metastatic disease.
3. Participants whose tumours are PD-L1 TPS ≥ 1%.
4. At least one measurable lesion per RECIST v1.1.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no worsening within 7 days prior to randomization.
6. A life expectancy of at least 12 weeks.
7. Adequate organ and bone marrow function.
Exclusion Criteria
2. Uncontrolled or clinical significant cardiovascular disease.
3. History of noninfectious pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.
4. Active infection requiring systemic therapy within 2 weeks of randomization.
5. Active hepatitis B or hepatitis C virus infection.
6. Human immunodeficiency virus (HIV) positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
7. Known allergy to SKB264 or pembrolizumab or any of its components.
8. Prior treatment with any of the following (including in the context of adjuvant, neoadjuvant therapy):
1. 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;
2. Therapy targeting TROP2.
3. Any drug therapy that targets topoisomerase I, including antibody-drug conjugates (ADCs).
9. Major surgery within 4 weeks prior to randomization or expected major surgery during the study.
10. Pregnant or lactating women.
18 Years
75 Years
ALL
No
Sponsors
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Shanghai Oriental Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SKB264-Ⅲ-12
Identifier Type: -
Identifier Source: org_study_id
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