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) KEYNOTE-091 - MK-3475-091

Merck Sharp & Dohme LLC0 个研究点目标入组 739 人开始时间: 2024年5月29日最近更新: 2024年8月21日

适应症

试验速览

阶段: 1 期
状态: 招募中
发起方: Merck Sharp & Dohme LLC
入组人数: 739

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

年龄范围: 18 至 65+（—）
性别: All

入选标准

•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;, ? No chronic use of immunosuppressive agents and/or systemic corticosteroids or any use in the last 3 days prior to the first infusion of trial treatment:, ? 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), ? Availability of tumor sample obtained at surgical resection for PD-L1 Immunohistochemistry (IHC) expression assessment. Patients must submit the tumor sample during screening for PDL1 IHC expression testing at a central pathology laboratory. Patients will be eligible to participate regardless of the level of PD-L1 status, however tissue must be considered satisfactory for characterization of PD-L1 status. Patients whose samples are inadequate for PD-L1 determination will not be randomized;, ? Resection margins proved microscopically free (R0); Resection margins are 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 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 lobespecific;, ? 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 extension of tumor in resected mediastinal (N2) lymph nodes. Extracapsular tumor extension is permitted in resected N1 lymph nodes;, ? 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;, ? Corticosteroid use on study for management of ECIs (pembrolizumab Event of Clinical Interest), as premedication for the administration of chemotherapies, and/or a premedication for IV contrast allergies/reactions is allowed;, ? Participants who receive adjuvant chemotherapy must begin adjuvant chemotherapy within 12 weeks of the surgery date. Patients receiving adjuvant chemotherapy must be randomized and dosed with pembrolizumab/placebo at least 3 weeks but no more than 12 weeks from the last dose of chemotherapy (Day 1 of last cycle)., ? Corticosteroid use on study for management of ECIs (pembrolizumab Event of Clinical Interest), as premedication for the administration of chemotherapies, and/or a premedication for IV contrast allergies/reactions is a

排除标准

•Not available. According to study design, all exclusion criteria are included within inclusion criteria.

研究者

发起方

Merck Sharp & Dohme LLC

相似试验

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)non-small cell lung cancer / lung cancer1003866610029107

NL-OMON53053Merck Sharp & Dohme (MSD)50

招募中

不适用

IMMUNOTHERAPEUTIC TREATMENT WITH PEMBROLIZUMAB (ANTIBODY) IN PATIENTS WITH EARLY STAGE NON-SMALL CELL LUNG CANCER-C349 Bronchus or lung, unspecifiedBronchus or lung, unspecifiedC349

PER-019-17Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.,

进行中（未招募）

1 期

Immunotherapeutic treatment with Pembrolizumab (antibody) in patients with early stage non-small cell lung cancerStage IB (T = 4 cm), II and IIIA NSCLCMedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2015-000575-27-DEMerck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.1,180

进行中（未招募）

1 期

Immunotherapeutic treatment with Pembrolizumab (antibody) in patients with early stage non-small cell lung cancerStage IB (T = 4 cm), II and IIIA NSCLCMedDRA version: 19.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2015-000575-27-LVMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.1,380

进行中（未招募）

1 期

EUCTR2015-000575-27-PTMerck Sharp & Dohme LLC1,180