NCT05483543招募中2 期
A Prospective, Phase II, Single-arm Study Evaluating the Efficacy and Safety of Pamiparib in Consolidation Therapy for Limited-stage Small Cell Lung Cancer That Has Not Progressed After Concurrent Chemoradiotherapy
适应症
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
- 44
- 试验地点
- 1
- 主要终点
- 1-year Progression Free Survival Rate
研究概览
简要总结
This study is a prospective, single-arm, phase II clinical trial, with 1-year PFS as the endpoint, to evaluate the efficacy and associated toxicity of Pamiparib as single-agent consolidation treatment in patients with limited-stage small cell lung cancer(LS-SCLC) patients who have not progressed following platinum-based concurrent chemoradiotherapy(cCRT) .
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient or a legally authorized representative must provide study-specific informed consent prior to study entry, had good compliance and cooperated with the follow-up.
- •Age at least 18 years
- •Pathologically (histologically or cytologically) proven diagnosis of limited stage small cell lung cancer (Stage Tx, T1-T4, N0-3, M0, American Joint Committee on Cancer [AJCC] staging, 8th edition [Ed.]), within 60 days prior to registration
- •Patients must have had measurable disease (per Response Evaluation Criteria in Solid Tumors [RECIST], version 1.1) prior to the required cycle of cCRT
- •Patients must be free of disease progression and not be able to receive other antitumor therapy within 6 weeks of completion of cCRT
- •Patients must submit archived or freshly biopsied tumor tissue (formalin-fixed, paraffin-embedded tissue block or approximately 15 unstained sections [must have >8 sections]) along with the relevant pathology report.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 30 days prior to registration
- •Patient life expectancy must be >12 weeks
排除标准
- •Mixed SCLC or NSCLC confirmed by histology
- •Previous tumor resection for LS-SCLC
- •Any patient treatable by surgery or stereotactic body radiation therapy/stereotactic ablative radiation therapy should be excluded
- •Expected to receive any other form of anti-tumor therapy during the study period
- •Previous treatment with PARP inhibitor drugs
- •Any active malignancy within 2 years prior to enrollment, excluding the specific cancers being studied in this study and locally recurrent cancers that have been cured (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, cervical cancer carcinoma in situ or carcinoma in situ of the breast)
- •Women who are pregnant, breastfeeding, or planning to become pregnant during the study
- •Concurrent participation in another therapeutic clinical trial
研究组 & 干预措施
Pamiparib monoagent
Experimental
Drug: Pamiparib 40mg bid orally
干预措施: Pamiparib (Drug)
结局指标
主要结局
1-year Progression Free Survival Rate
时间窗: One year after the start of intervention
One-year PFS rate was define as the percentage of patients who did not experience disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death due to any cause within 1 year from the date cCRT treatment ended.
次要结局
- Progression Free Survival(Two years)
- Overall Survival(Two years)
- AEs/SAEs(Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first)
研究者
Zhengfei Zhu
Fudan University
Fudan University
研究点 (1)
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