NCT07306624招募中2 期
A Multicenter, Phase 2 Clinical Trial Based on an Adaptive Design to Evaluate the Safety and Efficacy of Nelmastobart in Combination With Docetaxel in Patients With Advanced/Metastatic Non-Small Cell Lung Cancer Who Are Resistant or Intolerant to Platinum-based Chemotherapy and/or Immunotherapy
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- STCube, Inc.
- 入组人数
- 62
- 试验地点
- 6
- 主要终点
- Progression free survival by central reviewer
研究概览
简要总结
A Multicenter, Phase 2 Clinical Trial Based on an Adaptive Design to Evaluate the Safety and Efficacy of Nelmastobart in Combination with Docetaxel in Patients with Advanced/Metastatic Non-Small Cell Lung Cancer Who Are Resistant or Intolerant to Platinum-based Chemotherapy and/or Immunotherapy
详细描述
This is a singble arm, open label, phase 2 study to evaluate safety and preliminary efficacy for Nelmastobart 800mg and docetaxel 75mg/m2 combination regimen for both AGA negative and positive NSCLC patients who have failed at least 1 line of platinum based chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed stage IIIb, IIIc, or IV recurrent NSCLC
- •BTN1A1 TPS score ≥50
- •Subjects with positive AGA must have progressed after At least 1 platinum-based chemotherapy and/or immunotherapy AND at least 1 locally approved targeted therapy appropriate to the AGA
- •Subjects with negative AGA must have progressed after prior PD1/ (PDL therapy and/or at least 1platinum-based chemotherapy
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-
- •Adequate organ function as described in the protocol
- •Adequate cardiac function as described in the protocol
- •For female or male patients with reproductive potential: Agree to use contraception throughout the study and at least 5 months after the last dose.
- •Life expectancy of at least 3 months
- •Has agreed to provide archival tissue
排除标准
- •Known hypersensitivity to the active ingredients or excipients of the study drug.
- •History of using Docetaxel for palliative therapy.
- •Prior treatment with Cytotoxic chemotherapy or oral targeted therapy within 14 days.
- •Investigational drugs within 5 half-lives.
- •Monoclonal antibodies or ADCs within 4 weeks.
- •Use or expected use of strong CYP3A4 inhibitors (e.g., ketoconazole) within 14 days prior to the first dose.
- •Uncontrolled severe infection requiring IV treatment, or suspected infectious complications/fever.
- •Requirement for continuous high-dose steroids (>10 mg/day prednisone equivalent) or immunosuppressants within 7 days (excluding Docetaxel premedication; intermittent/replacement therapies allowed).
- •Pregnant or breastfeeding women.
- •History of autoimmune disease requiring systemic treatment within the last 2 years
- •Known active symptomatic or radiologically unstable CNS lesions
- •History of stroke, unstable angina, MI, or NYHA Class III-IV symptoms within 6 months, or current Class II.
- •Systolic BP 160 mmHg or Diastolic BP 100 mmHg, or hypertensive encephalopathy.
- •History of ILD, organizing/drug-induced pneumonia, or active pneumonia on screening (mild asymptomatic fibrosis requires consultation).
- •Recipients of allogeneic stem cell or solid organ transplants.
- •Vaccination with live or attenuated live vaccines within 30 days.
- •Maligancies other than NSCLC
- •Failure to recover from prior anti-cancer therapy side effects to CTCAE Grade 1
- •Wide-field bone marrow radiation (>30%) within 4 weeks, or limited palliative radiation within 2 weeks.
- •Major surgery within 4 weeks or incomplete recovery from surgical side effects.
- •Evidence of active HBV, HCV, or HIV infection (carriers with negative viral loads/RNA may be eligible).
- •Clinically unstable pleural or peritoneal effusion (stable cases after intervention are allowed).
研究组 & 干预措施
Nelmastobart 800mg+Docetaxel 75mg/m2
Experimental
Nelmastobart 800mg+Docetaxel 75mg/m2 fixed
干预措施: Nelmastobart and Docetaxel (Drug)
结局指标
主要结局
Progression free survival by central reviewer
时间窗: up to 3 years
Time from first dose until the date of objective disease progression or death assessed by central reviewer
次要结局
- Cmax(3 weeks)
- Area under concentration-time curve(15 weeks)
- Disease control rate, DCR(Up to 3 years)
- Duration of Response(Up to 3 years)
- Progression free survival rate(6 month)
- Overall survival(up to 3 years)
- Overall survival(up to 3 years)
- Progression Free Survival assessed by Investigator(Up to 3 years)
- Objective response rate, ORR(Up to 3 years)
- Disease control rate, DCR(Up to 3 years)
- Duration of Response(Up to 3 years)
- Progression free survival rate(6 month)
- Cmax(3 weeks)
- Area under concentration-time curve(15 weeks)
- Adverse event(time from the date of the first dose of study drug until 30 days after last dose)
研究者
研究点 (6)
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