NL-OMON53053招募中3 期
A randomized, phase 3 trial with anti-PD-1 monoclonal antibody pembrolizumab (MK-3475) versus placebo for patients with early stage NSCLC after resection and completion of standard adjuvant therapy (PEARLS) - PEARLS
Merck Sharp & Dohme (MSD)0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patient enrollment will follow a three- steps procedure as illustrated in
- •Section 4 (step 1 registration, step 2 central confirmation of PD-L1 status,
- •step 3 randomization). Patients must meet all of the criteria described in
- •Sections 3.1, 3.2 and 3.3 to be eligible for randomization in step 3.
- •1) Registration - step 1 (ORTA step 1)
- •Before patient registration, written informed consent for tumor testing must be
- •given according to ICH/GCP and national/local regulations. For patients that
- •accept to participate in the translational research, we recommend the informed
- •consent for translational research be signed before registration step 1;
- •Pathological diagnosis of NSCLC confirmed at surgery, any histology is eligible;
- •Confirmed UICC v7 stage IB with T >= 4 cm, II-IIIA NSCLC after complete surgical
- •resection (lobectomy, sleeve lobectomy, bi-lobectomy or pneumonectomy) as
- •documented in the pathology report;
- •(Note: TNM stage according to the 7th edition of the TNM classification for
- •lung cancer)
- •Resection margins proved microscopically free (R0); Resection margins should
- •must be considered to beare evaluated at the bronchial, venous and arterial
- •stumps, peribronchial soft tissue, any peripheral margin near the tumor or of
- •additionally resected tissue;
- •A systematic complete mediastinal lymph node dissection or a lobe-specific
- •mediastinal lymph node dissection (Appendix K) is recommended. At a minimum,
- •the pathology and/or operative report must include the examination of at least
- •two different mediastinal lymph node (N2) levels, one of which is the
- •subcarinal (level 7) and the second of which is lobe-specific;
- •A systematic nodal dissection is recommended or at least a lobe-specific
- •systematic nodal dissection. However, the intraoperative lymph node evaluation
- •can be accepted if no lymph nodes are found in those area and there is clear
- •documentation in the operative report by the surgeon of exploration of the
- •required lymph node areas. At minimum, the pathology and/or operative report
- •should include the examination of at least two different mediastinal nodal (N2)
- •station with one being subcarinal (level 7);
- •In the uncommon clinical situation where the surgeon thoroughly examines a
- •particular mediastinal lymph node level and does not find any lymph nodes, that
- •mediasintal lymph node level may be counted among the minimum two required
- •levels. However, the surgeon must clearly document in the operative report or
- •in a separate written statement that the lymph node level was explored and no
- •lymph nodes were present. Normal appearing lymph nodes, if present, must be
- •biopsied or/removed;
- •No extracapsular nodal extension of the tumor in resected mediastinal (N2)
- •lymph nodes. Extracapsular tumor extension is permitted in resected N1 lymph
- •The highest mediastinal node removed can be positive for malignancy;.
- •Carcinoma in situ can be present at bronchial margin;.
- •Patients with two synchronous primary non-small cell lung cancers are excluded
- •from the study;
- •Availability of tumor sample obtained at surgical resection for PD-L1
- •Immunohistochemistry (IHC) expression assessment. Patients must submit the
- •tumor sample during screening for PD-L1 IHC expression testing at a central
- •pathology laboratory. Patients will be eligible to participate regardless of
- •the level of PD
排除标准
- •Please refer to D4a. All eligibility criteria are listed in this section.
研究者
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