A Phase 3, Randomized, Double-blind, Multicenter Study of MK-1084 in Combination With Pembrolizumab Compared With Pembrolizumab Plus Placebo as First-line Treatment of Participants With KRAS G12C-Mutant, Metastatic NSCLC With PD-L1 TPS >=50%

MSD K.K.0 个研究点目标入组 40 人开始时间: 2024年11月5日最近更新: 2025年4月15日

适应症

试验速览

阶段: 不适用
状态: 尚未招募
发起方: MSD K.K.
入组人数: 40
主要终点: Progression-free survival(PFS)

研究概览研究设计入排标准结局指标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
分配方式: Randomized Controlled Trial
干预模型: Parallel Assignment
主要目的: Treatment Purpose
盲法: Double Blind

入排标准

年龄范围: 18age old over 至 No limit（—）
性别: All

入选标准

•Has a histologically or cytologically confirmed diagnosis of Non-Small Cell Lung Cancer(NSCLC)
•Has newly diagnosed Stage IV NSCLC by American Joint Committee on Cancer (AJCC) Staging Manual, Version 8
•Has measurable disease based on Response Evaluation Criteria In Solid Tumors(RECIST) 1.1
•Has provided tumor tissue that demonstrates PD-L1 expression in >=50% of tumor cells
•Has provided tumor tissue that demonstrates presence of KRAS G12C mutation
•Has life expectancy of at least 3 months
•Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days before randomization
•For participant assigned male sex at birth: If capable of producing sperm, participant must agree to the following during the study treatment period and for at least 10 days after the last dose of oral intervention: Either be abstinent or must agree to use male condom plus additional contraceptive method.
•For participant assigned female sex at birth: Either be a person of nonchildbearing potential (PONCBP) or must agree to follow contraceptive guidance during the study treatment period and for at least 10 days after the last dose of oral intervention and 120 days after the last dose of pembrolizumab. Must abstain from breastfeeding during the study intervention period and for at least 120 days after study intervention.
•Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART).
•Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization

排除标准

•Diagnosis of small cell lung cancer
•Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease
•Has a known history of, or active, neurologic paraneoplastic syndrome
•Has an active infection requiring systemic therapy
•Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QT interval corrected for heart rate by Fridericia's formula (QTcF) interval to >470 ms, and/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention
•Is considered a poor medical risk due to a serious, uncontrolled medical disorder or nonmalignant systemic disease. Examples include, but are not limited to, uncontrolled major seizure disorder, unstable spinal cord compression, or superior vena cava syndrome.
•Has one or more of the following ophthalmological findings/conditions: intraocular diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion, diagnosis of retinal degenerative disease pressure >21 mm Hg and/or any diagnosis of glaucoma
•Is unable to swallow orally administered medication, or has a gastrointestinal disorder affecting absorption (eg, gastrectomy, partial bowel obstruction, or malabsorption)
•Received prior systemic anticancer therapy for their metastatic NSCLC
•Received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor within 12 months before diagnosis of metastatic NSCLC
•Has received radiotherapy within 2 weeks of start of study intervention
•Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
•Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
•Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
•Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
•Active autoimmune disease that has required systemic treatment in the past 2 years
•History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
•HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
•History of allogeneic tissue/solid organ transplant
•Has not fully recovered from any effects of major surgical procedure. Surgical procedures that required general anesthesia must be completed at least 2 weeks before first study intervention administration.

结局指标

主要结局

Progression-free survival(PFS)

the time from the date of randomization until either documented disease progression or death due to any cause, whichever occurs first

Overall survival (OS)

the time from randomization to death due to any cause

次要结局

Objective response
Duration of response(DOR)
Change in score from baseline in the following patient-reported outcome(PRO) scales/items
Time to deterioration in a given scale item from baseline

研究者

发起方

MSD K.K.

相似试验

进行中（未招募）

1 期

Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer.Metastatic Castration-Resistant Prostate Cancer (mCRPC)MedDRA version: 21.1Level: LLTClassification code 10076506Term: Castration-resistant prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2016-002312-41-NLMerck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc1,200

进行中（未招募）

1 期

Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in mCRPCMetastatic Castration-Resistant Prostate Cancer (mCRPC)MedDRA version: 19.0Level: LLTClassification code 10076506Term: Castration-resistant prostate cancerSystem Organ Class: 100000004864

EUCTR2016-002312-41-FRMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc210

进行中（未招募）

1 期

EUCTR2016-002312-41-IEMerck Sharp & Dohme LLC1,200

进行中（未招募）

1 期

EUCTR2016-002312-41-ATMerck Sharp & Dohme LLC1,200

进行中（未招募）

1 期

Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer.

EUCTR2016-002312-41-DKMerck Sharp & Dohme LLC1,200