NCT07120282招募中2 期
A Randomized, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Adjuvant Tislelizumab in High-Risk Stage I NSCLC
Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2025年10月28日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- 2 year disease-free survival rate, 2y-DFS rate
研究概览
简要总结
A Randomized, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Adjuvant Tislelizumab in High-Risk Stage I NSCLC
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide written informed consent form (ICF) and agree to follow study requirements and assessment schedule.
- •Aged 18 years or older.
- •Histologically confirmed stage I non - small cell lung cancer (AJCC 9th edition), with tumor size 2cm <= T <=4cm.
- •Postoperative pathological report shows at least one high-risk factor (visceral pleural invasion, lymphovascular invasion, STAS, poorly differentiated status, high-grade invasive adenocarcinoma (any structure + high grade structure >=20%, including solid, micropapillary, or complex glands)).
- •ECOG performance status 0 or
- •PD-L1 expression >=1%.
- •No EGFR/ALK sensitive mutations.
- •Achieved complete resection (R0) .
- •Within 8 weeks after surgery, with full recovery from operation.
- •Adequate organ function.
排除标准
- •Any previous treatment for current lung cancer, including radiotherapy and systemic anti-tumour therapies (chemotherapy, immunotherapy, targeted therapy, anti-angiogenesis therapy, etc.).
- •Prior chest radiotherapy (including lung, oesophageal, mediastinal, or breast cancer).
- •Patients with large - cell neuroendocrine carcinoma (LCNEC) or mixed - subtype non - small - cell lung cancer with small - cell components.
- •With EGFR/ALK sensitive mutations.
- •Underwent segmentectomy or wedge resection only.
- •Tumours involving main bronchi, or with obstructive pneumonia/atelectasis (partial or whole lung).
- •Active autoimmune disease or history of relapsing autoimmune disease.
- •History of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonitis needing hormone therapy, or current active interstitial lung disease, or on relevant treatment/intervention.
- •Any condition needing systemic corticosteroid (> 10 mg/d prednisone or equivalent) or other immunosuppressant within 14 days before randomisation
- •Used other approved systemic immunomodulators (interferon, interleukin - 2, tumour necrosis factor, thymopentin, thymosin α1, etc.) within 4 weeks before first dose.
- •Herbs used for cancer control within 14 days before first study
- •Live/attenuated vaccine receipt within 4 weeks before enrollment, or plan to receive during study or within 5 months after last tislelizumab dose.
- •History of significant disease or conditions affecting organ/system function, per investigator's judgment.
- •Severe chronic/active infection needing systemic antibacterial, antifungal, or antiviral therapy (e.g., tuberculosis) within 14 days before first study-drug dose. ·Known HIV infection.
- •Allogeneic stem - cell/organ transplant history.
- •Active malignancy within 2 years before enrollment, except the specific cancer studied and locally recurrent cancers cured (e.g., excised basal/squamous - cell skin cancer, superficial bladder cancer, cervical/ breast carcinoma in situ).
- •Specific conditions and/or alcohol/drug abuse or dependence that may hinder drug administration, affect outcome interpretation, or increase complication risks.
- •Pregnant/breastfeeding women, or men/women planning to conceive during the study.
- •Participation in another interventional clinical study (except observational studies or follow-up phases).
研究组 & 干预措施
Intervention group
Experimental
Tislelizumab 400 mg iv, q6w, for up to 1 year; patients are permitted to receive concurrent adjuvant platinum-based doublet chemotherapy (q3w, up to 4 cycles) starting from the first dose of tislelizumab; during concurrent chemotherapy, a tislelizumab dosage of 200 mg iv, q3w is allowed.
干预措施: Tislelizumab 400 mg iv, q6w, for up to 1 year for pts in intervention group (Drug)
Control group
No Intervention
Patients are permitted to receive postoperative adjuvant platinum - based doublet chemotherapy (q3w, up to 4 cycles).
结局指标
主要结局
2 year disease-free survival rate, 2y-DFS rate
时间窗: From the start of randomization to two years later
次要结局
- disease-free survival, DFS(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months)
- overall survival, OS(From date of randomization until the date of death from any cause, assessed up to 60 months)
- Number of Participants with Adverse Events as Assessed by CTCAE v5.0(From enrollment to the end of systemic anti-tumor treatment at 30 days (90 days for recording irAE ))
研究者
Zhijie Wang
Chief Physician
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
研究点 (1)
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