NCT05870319进行中（未招募）3 期
A Randomized, Open-Label, Multicenter Phase 3 Study to Evaluate SKB264 Monotherapy Versus Pemetrexed in Combination With Platinum in Patients With Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With EGFR Mutation Who Have Failed to Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 376
- 试验地点
- 2
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
This is a randomized, open-label, multicenter Phase 3 clinical study to evaluate SKB264 monotherapy versus pemetrexed in combination with platinum in subjects with locally advanced or metastatic non-squamous NSCLC with EGFR mutation who have failed to EGFR-TKI therapy.
详细描述
This is a randomized, open-label, multicenter Phase 3 clinical study to evaluate SKB264 monotherapy versus pemetrexed in combination with platinum in subjects with locally advanced or metastatic non-squamous NSCLC with EGFR mutation who have failed to EGFR-TKI therapy. The primary objective is to compare the efficacy and safety of SKB264 monotherapy versus pemetrexed in combination with platinum in patients with locally advanced or metastatic non-squamous NSCLC with EGFR mutation who have failed to EGFR-TKI therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged ≥18 to ≤75 years at the time of signing the ICF;
- •Histologically or cytologically confirmed non-squamous NSCLC and locally advanced (stage IIIB/IIIC) or metastatic (Stage IV) non-squamous NSCLC not amenable to radical surgery and/or radical concurrent/sequential chemoradiotherapy;
- •EGFR-sensitive mutations;
- •Failure of prior EGFR-TKI therapy;
- •At least one measurable target lesion per RECIST 1.1 as assessed by the investigator;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- •Expected survival ≥12 weeks;
- •Adequate organ and bone marrow function;
- •Female subjects of childbearing potential and male subjects with partners of childbearing potential who use effective medical contraception from the time of signing the informed consent form until 6 months after the last dose;
- •Subjects voluntarily participate in the study, sign the ICF, and will be able to comply with the protocol-specified visits and relevant procedures
排除标准
- •Histologically or cytologically confirmed presence of small cell lung cancer, neuroendocrine carcinoma, and carcinosarcoma components or squamous cell carcinoma components of more than 10%;
- •Other malignancies within 3 years prior to the first dose;
- •History of (noninfectious) interstitial lung disease (ILD)/noninfectious pneumonitis requiring steroid therapy and current ILD/noninfectious pneumonitis;
- •Subjects with active chronic inflammatory bowel disease, GI tract obstruction, severe ulcers, perforation gastrointestinal, abdominal abscess, or acute GI tract bleed;
- •Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1 (per NCI CTCAE 5.0) or to the level specified in the eligibility criteria;
- •Subjects with human immunodeficiency virus (HIV) test positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection;
- •Prior TROP2-targeted therapy;
- •Prior treatment with any drug therapy targeting topoisomerase I inhibitor, including antibody-drug conjugates (ADCs);
- •Major surgery within 4 weeks prior to the first dose or expected to require major surgery during the study;
- •Subjects who have received live vaccines within 30 days prior to the first dose, or are scheduled to receive live vaccines during the study;
- •Pregnant or lactating women;
研究组 & 干预措施
SKB264 by IV infusion on Days 1 and 15 of each 4-week cycle;
Experimental
干预措施: SKB264 (Drug)
pemetrexed+ carboplatin or on Day 1 of each 3-week cycle, with 4 cycles chemo
Active Comparator
干预措施: Pemetrexed (Drug)
pemetrexed+ carboplatin or on Day 1 of each 3-week cycle, with 4 cycles chemo
Active Comparator
干预措施: Carboplatin (Drug)
pemetrexed+ carboplatin or on Day 1 of each 3-week cycle, with 4 cycles chemo
Active Comparator
干预措施: Cisplatin (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: From baseline until disease progression, death, or other protocol defined reason,up to approximately 36 months
PFS assessed by BIRC per RECIST 1.1
次要结局
- Overall survival (OS)(From the date of randomization to the date of death due to any cause. Up to 2 years.)
- Progression-free survival (PFS)(From baseline until disease progression, death, or other protocol defined reason,up to approximately 36 months)
- Duration of response(DOR)(From baseline until disease progression, death, or other protocol defined reason, up to approximately 36 months)
- Time to response(TTR)(Up to 2 years)
- Objective response rate(ORR)(Up to 2 years)
- Disease control rate(DCR)(Up to 2 years)
- AEs and SAEs(AEs should be observed and recorded from signing the ICF until 30 days after the last dose. AEs occurring 30 days after the last dose are not required to be actively collected by the investigator.)
- Mean change from baseline in the European Organisation for Research and Treatment of Cancer (EORTC) complementary 13-item quality-of-life questionnaire - lung cancer symptoms questionnaire (QLQ-LC13)(Up to 2 years)
- Mean change from baseline in the European Organisation for Research and Treatment of Cancer (EORTC) 30-item core quality-of-life questionnaire (QLQ-C30）(Up to 2 years)
研究者
研究点 (2)
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