2022-502738-18-00招募中2 期
MASTER PROTOCOL: A Phase 2, Open-label, Multi-arm Study of Tislelizumab in Combination With Investigational Agents With or Without Chemotherapy in Patients With Previously Untreated, Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer.
Beigene Ltd., Beigene Ltd., Beigene Ltd.9 个研究点 分布在 4 个国家目标入组 22 人开始时间: 2023年8月22日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 22
- 试验地点
- 9
- 主要终点
- Confirmed overall response rate (ORR) as assessed by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1
研究概览
简要总结
To assess the antitumor activity of tislelizumab plus investigational agent(s) with or without chemotherapy.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Histologically or cytologically confirmed NSCLC (nonsquamous or squamous) that is locally advanced or recurrent and not eligible for curative surgery and/or definitive chemoradiotherapy, or metastatic NSCLC.
- •No prior systemic treatment given as primary therapy for metastatic NSCLC. Prior adjuvant/neoadjuvant chemotherapy or definitive chemoradiation/adjuvant radiotherapy for locally advanced disease is allowed provided the last dose of chemotherapy and/or radiotherapy occurred at least 6 months before randomization/enrollment.
- •Evaluable tumor PD-L1 expression as determined by a local laboratory or by central laboratory on archival tumor tissue or fresh biopsy. Patients with unknown PD-L1 expression will not be eligible for this study.
- •At least 1 measurable lesion as defined per RECIST v1.1
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •NOTE: Other protocol and sub-study protocol defined criteria may apply
排除标准
- •Has mixed small cell lung cancer.
- •Patients with known EGFR mutations or actionable mutations with available targeted therapies.
- •Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-TIGIT, anti-LAG-3 or any other antibody or drug targeting T-cell costimulation or immune checkpoint pathways. Note: Patients who received prior neoadjuvant, adjuvant or immuno-oncology therapies targeting PD-1 or PD-L1 in consolidation are eligible, if there has been a treatment-free interval of ≥ 6 months from last dose of immuno-oncology therapy prior to radiologic recurrence of disease.
- •Has received any Chinese herbal medicine or Chinese patent medicines used to control cancer ≤ 14 days before randomization/enrollment.
- •Active leptomeningeal disease or uncontrolled, untreated brain metastasis, or active autoimmune diseases.
- •NOTE: Other protocol and sub-study protocol defined criteria may apply
结局指标
主要结局
Confirmed overall response rate (ORR) as assessed by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1
Confirmed overall response rate (ORR) as assessed by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1
次要结局
- Progression-free survival (PFS), duration of response (DOR), clinical benefit rate (CBR), and disease control rate (DCR) as assessed by the investigator per RECIST v1.1.
- The incidence and severity of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events NCI-CTCAE v5.0 in reference arms and experimental arms.
- Plasma or serum concentrations of tislelizumab and investigational agents at specified timepoints.
- Immunogenic responses to tislelizumab and investigational protein therapeutics, evaluated through the detection of antidrug antibodies (ADA).
研究者
BeiGene Clinical Support
Scientific
Beigene Ltd.
研究点 (9)
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