A Randomized, Phase 3, Open-label Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab versus Intravenous Pembrolizumab, Administered with Platinum Doublet Chemotherapy, in the First-Line Treatment of Participants with Metastatic Squamous or Nonsquamous Non-Small-Cell Lung Cancer - MK-3475-A86

Merck Sharp & Dohme LLC0 个研究点目标入组 531 人开始时间: 2024年3月6日最近更新: 2024年7月22日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Merck Sharp & Dohme LLC
入组人数: 531

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 65+（—）
性别: All

入选标准

•Has pathologically (histologically or cytologically) confirmed diagnosis of squamous or nonsquamous non-small cell lung cancer (NSCLC), Has adequate organ function, Has Stage IV (T any, N any, M1a, M1b, or M1c - American Joint Committee on Cancer 8th Edition) squamous or nonsquamous NSCLC, Has confirmation that epidermal growth factor receptor (EGFR), Anaplastic lymphoma kinase (ALK), or Receptor Tyrosine Kinase 1 (ROS1)-directed therapy is not indicated in nonsquamous NSCLC as well as mixed nonsquamous/squamous NSCLC. Participants with purely squamous NSCLC do not require testing, Has not received prior systemic treatment for their metastatic NSCLC. Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the development of metastatic disease, Has an Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 0 or 1, Male participants are eligible to participate if they agree to use contraception as per protocol unless confirmed to be azoospermic, A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of childbearing potential (WOCBP) or is a WOCBP who agrees of using a contraceptive method per protocol, Has measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the local site investigator/radiology, Submit an archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated for PD-L1 status determination prior to randomization

排除标准

•Has a known additional malignancy that is progressing or has required active treatment within the past 3 years, Before the first dose of study intervention: a) Has received prior systemic cytotoxic chemotherapy for metastatic NSCLC b) Has received antineoplastic biological therapy for metastatic NSCLC c) Has had major surgery (<3 weeks prior to first dose) d) Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor, Received radiation therapy to the lung that is >30 Gray within 6 months of the first dose of study intervention, Is expected to require any other form of antineoplastic therapy while on study, For participants with nonsquamous histology: Is unable to interrupt aspirin or other Non-steroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose =1.3 g/day, for a 5-day period, For participants with nonsquamous histology: Is unable or unwilling to take folic acid or vitamin B12 supplementation, Has received prior radiotherapy within 2 weeks of start of study intervention or have had a history of radiation pneumonitis. Participants must have recovered from all radiation-related toxicities and not require corticosteroids. A 1-week washout is permitted for palliative radiation (=2 weeks of radiotherapy) to non-central nervous system (CNS) disease, Has received a live or live attenuated vaccine within 30 days prior to the first dose of study intervention, Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention, Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention, Has had an allogenic tissue/solid organ transplant, Has known central nervous system (i.e., brain and/or spinal cord) metastases and/or carcinomatous meningitis. Participants with treated brain metastases may participate only if they satisfy all of the following: a) Have no evidence of new or enlarging brain metastases confirmed by post-treatment repeat brain imaging performed at least 4 weeks after pretreatment brain imaging, and b) Are neurologically stable without the need for steroids for at least 14 days before first dose of trial treatment as per local site assessment, Has severe hypersensitivity to study intervention and/or any of its excipients, Has an active autoimmune disease that has required systemic treatment in past 2 years, Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease, Has an active infection requiring systemic therapy, Has a known history of human immunodeficiency virus (HIV) infection and/or Hepatitis B infection or known active Hepatitis C infection, Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study, Has symptomatic ascites or pleural effusion. A participant who is clinically stable after treatment for these conditions is eligible

研究者

发起方

Merck Sharp & Dohme LLC

相似试验

进行中（未招募）

1 期

Phase 3 study of pembrolizumab SC versus pembrolizumab IV, administered with platinum doublet chemotherapy, in 1L metastatic squamous or nonsquamous NSCLCMetastatic Squamous or Nonsquamous Non-Small-Cell Lung CancerMedDRA version: 21.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2020-002729-27-FRMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.450

进行中（未招募）

1 期

EUCTR2020-002729-27-HUMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.450

进行中（未招募）

3 期

Phase 3 study of pembrolizumab SC versus pembrolizumab IV, administered with platinum doublet chemotherapy, in 1L metastatic squamous or nonsquamous NSCLCon-Small Cell Lung Cancer

JPRN-jRCT2021210032Ishii Takeaki60

进行中（未招募）

1 期

EUCTR2020-002729-27-ROMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.450

招募中

3 期

Phase 3 study of pembrolizumab SC versus pembrolizumab IV, administered with platinum doublet chemotherapy, in 1L metastatic squamous or nonsquamous NSCLCC34 Malignant neoplasm of bronchus and lungMalignant neoplasm of bronchus and lung

PER-033-21Merck Sharp & Dohme LLC., (una subsidiaria de Merck & Co. Inc.)34