A Multicenter, Double Blind, Randomized, Controlled Study of M7824 with Concurrent Chemoradiation Followed by M7824 versus Concurrent Chemoradiation Plus Placebo Followed by Durvalumab in Participants with Unresectable Stage III Non-small Cell Lung Cancer - MS200647_0005 (Intr@pid Lung 005)

Merck0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Merck
入组人数: 20

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

入排标准

年龄范围: 18 至 99（—）

入选标准

•Participants are eligible to be included in the study only if all the following
•criteria apply:
•1. Are * 18 years of age at the time of signing the informed consent. In Japan,
•if a patient is < 20 years, the written informed consent from his/her parent or
•guardian will be required in addition to the patient*s written consent., Type
•of Participant and Disease Characteristics
•2. Participants must have measurable or non-measurable but evaluable disease
•assessed by the Investigator. Participants must have histologically documented
•NSCLC who present with Stage III locally advanced, unresectable disease
•(International Association for the Study of Lung Cancer Staging Manual in
•Thoracic Oncology [IASLC Staging Manual in Thoracic Oncology], v8).
•3. Availability of tumor material (< 6 months old) adequate for biomarker
•analysis is
•Mandatory for all participants and central laboratory confirmation is required.
•For participants enrolled in the safety run-in, PD-L1 expression will be tested
•retrospectively by a central laboratory. For participants enrolled in the
•expansion part of the study, PD-L1 expression must be tested by the central
•laboratory and results available before randomization. Only results from the
•central laboratory testing will be used for randomization and if PD-L1 status
•is non-evaluable, the participant is not eligible for this study. Tumor samples
•obtained by endoscopic biopsies, core needle biopsies, excisional biopsies,
•punch biopsies, and surgical specimen that are < 6 months old and adequate for
•biomarker analysis are acceptable. Biopsies obtained by fine needle aspiration
•are not acceptable., 4. Participants with tumor harboring an EGFR sensitizing
•(activating) mutation, ALK
•translocation, ROS-1 rearrangement are eligible. These tests are not required
•for enrollment in the study.
•5. Participants with ongoing post-obstructive pneumonia due to the tumor are
•6. If a pleural effusion is present, the following criteria must be met to
•exclude malignant
•involvement (incurable T4 disease):
•a. When pleural fluid is visible on both the CT scan and on a chest x-ray, a
•thoracentesis is required to confirm that the pleural fluid is cytologically
•b. Participants with exudative pleural effusions are excluded, regardless of
•c. Participants with effusions that are minimal, i.e., are too small to safely
•tap are eligible.
•7. Participants must be at least 3 weeks from prior thoracotomy (if performed).
•8. Participants must have adequate pulmonary function defined as a forced
•expiratory volume in 1 second (FEV1) * 1.2 liters or * 50% of predicted normal
•volume measured within 3 weeks prior to randomization. If participants do not
•meet the above criteria, treatment with inhaled steroids and bronchodilators
•can be initiated if clinically indicated and eligibility can be reassessed
•after 1-2 weeks.
•9. ECOG performance status of 0 to 1 at Screening and on the day of first dose.
•10. Life expectancy *12 weeks.
•11. Have adequate organ function as indicated by the following laboratory values
•a. Adequate hematological function defined by absolute neutrophil count (ANC) *
•× 109/L, platelet count * 100 × 109/L, and hemoglobin * 9 g/dL.
•b. Adequate hepatic function defined by a total bilirubin level * 1.5 × upper
•limit of nor

排除标准

•Participants are excluded from the study if any of the following criteria apply:
•Medical Conditions
•1. Mixed small cell with non-small cell lung cancer histology.
•2. Greater than minimal, exudative, or cytologically positive pleural effusions.
•3. Recent major surgery within 4 weeks prior to entry into the study (excluding
•the placement
•of vascular access) that would prevent administration of study drug.
•4. Active or prior documented inflammatory bowel disease (e.g., Crohn*s
•disease, ulcerative colitis).
•5. History of organ transplant that requires therapeutic immunosuppression.
•6. Significant acute or chronic infections including, among others:
•a. Known history of positive test for human immunodeficiency virus (HIV) or
•acquired immunodeficiency syndrome (testing at Screening is not required). If an
•Investigator has a strong suspicion of HIV infection without known history for a
•participant in Screening, however participant refuses testing, discuss with
•Monitor to assess eligibility. (Note: HIV testing is not mandated for study
•however, if it is performed at any point in Screening or while on study, a site
•consent the participant for HIV testing as per local standard guidance.)
•b. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (HBV
•antigen positive and HBV core antibody positive with reflex to positive HBV
•HBV core antibody positive alone with reflex to positive HBV DNA, or positive
•antibody with reflex to positive HCV RNA) at Baseline. Discuss with the Medical
•Monitor if history of HBV or HCV infection is known. If medically indicated,
•participants infected with HBV must be treated and on a stable dose of
•antivirals (e.g,
•entecavir, tenofovir, or lamivudine; adefovir or interferon are not allowed) at
•study entry
•and with planned monitoring and management according to appropriate labeling
•guidance. Participants on active HCV therapy at study entry must be on a stable
•without documented clinically significant impaired liver function test or
•hematologic
•abnormalities (must meet criteria above) and with planned monitoring and
•according to appropriate labeling guidance. HBV and/or HCV viral titers must be
•monitored according to SoA in these participants.
•c. Participants with active tuberculosis (history of exposure or history of
•tuberculosis test; plus presence of clinical symptoms, physical, or
•radiographic findings).
•7. Uncontrolled intercurrent illness including, but not limited to, symptomatic
•heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac
•arrhythmia,
•active peptic ulcer disease or gastritis, active bleeding diatheses, or
•psychiatric illness/social situations that would limit compliance with study
•requirements or
•compromise the ability of the patient to give written informed consent.
•Participants with history of bleeding diathesis or recent major bleeding events
•considered by the Investigator as high risk for investigational drug treatment
•are also excluded.
•8. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory
•illness requiring hospitalization or precluding study therapy within 30 days
•before randomization.
另有 1 项未显示

研究者

发起方

Merck

相似试验

进行中（未招募）

1 期

M7824 with cCRT in Unresectable Stage III NSCLCnresectable Stage III Non-small Cell Lung CancerMedDRA version: 20.0Level: PTClassification code 10029519Term: Non-small cell lung cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2018-003265-34-ESMerck KGaA350

进行中（未招募）

1 期

M7824 with cCRT in Unresectable Stage III NSCLCnresectable Stage III Non-small Cell Lung CancerMedDRA version: 21.1Level: PTClassification code 10029519Term: Non-small cell lung cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2018-003265-34-DEMerck KGaA160

进行中（未招募）

1 期

EUCTR2018-003265-34-HUMerck KGaA160

进行中（未招募）

1 期

M7824 with cCRT in Unresectable Stage III NSCLC

EUCTR2018-003265-34-BEMerck KGaA160

进行中（未招募）

1 期

M7824 with cCRT in Unresectable Stage III NSCLCnresectable Stage III Non-small Cell Lung CancerMedDRA version: 20.0 Level: PT Classification code 10029519 Term: Non-small cell lung cancer stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2018-003265-34-FRMerck KGaA350