NL-OMON50379已完成3 期
A Randomized, Double-Blind, Phase III Study of Platinum+Pemetrexed Chemotherapy with or without Pembrolizumab (MK-3475) in First Line Metastatic Non-squamous Non-small Cell Lung Cancer Subjects (KEYNOTE-189). - MK3475-189
Merck Sharp & Dohme (MSD)0 个研究点目标入组 9 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
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
- •Have a histologically-confirmed or cytologically-confirmed diagnosis of stage
- •IV (M1a or M1b AJCC 7th edition) nonsquamous NSCLC., • Have confirmation that
- •EGFR or ALK-directed therapy is not indicated., •Have measurable disease based
- •on RECIST 1.1 as determined by the local site investigator/radiology
- •assessment. Target lesions situated in a previously irradiated
- •area are considered measurable if progression has been demonstrated in such
- •Have not received prior systemic treatment for their advanced/metastatic
- •NSCLC. Subjects 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., •Have provided tumor tissue from locations
- •not radiated prior to biopsy; formalin-fixed specimens after the subject has
- •been diagnosed with metastatic disease will be preferred for determination of
- •PD-L1 status prior to randomization. Biopsies obtained prior to receipt of
- •adjuvant chemotherapy will be permitted if recent biopsy is not feasible., •Be
- •18 years of age or older on day of signing informed consent. , • Have a life
- •expectancy of at least 3 months., •Have a ECOG performance status of 0 or 1,
- •Have adequate organ function as indicated by the laboratory values specified
- •in the protocol , •If female of childbearing potential, have a negative urine
- •or serum pregnancy test within 72 hours prior to receiving the first dose of
- •study medication. If the urine test is positive or cannot be confirmed as
- •negative, a serum pregnancy test will be required., •If female of childbearing
- •potential, be willing to use an adequate method of contraception as outlined in
- •the protocol, for the course of the study through 120 days after the last dose
- •of study medication or through 180 days after last dose of chemotherapeutic
- •agents as specified in the protocol. , •If male subject with a female
- •partner(s) of child-bearing potential, must agree to use an adequate method of
- •contraception as outlined in the protocol, starting with the first dose of
- •study therapy through 120 days after the last dose of study therapy or through
- •180 days after last dose of chemotherapeutic agents as specified in the
- •protocol. Males with pregnant partners must agree to use a condom; no
- •additional method of contraception is required for the pregnant partner.,
- •Subject has voluntarily agreed to participate by giving written informed
- •consent/assent for the trial. The subject may also provide consent/assent for
- •Future Biomedical Research. However, the subject may participate in the main
- •trial without participating in Future Biomedical Research.
排除标准
- •Has predominantly squamous cell histology NSCLC. Mixed tumors will be
- •categorized by the predominant cell type; if small cell elements are present,
- •the subject is ineligible., •Is currently participating and receiving study
- •therapy or has participated in a study of an investigational agent and received
- •study therapy or used an investigational device within 4 weeks prior to
- •administration of pembrolizumab., •Before the first dose of trial treatment:
- •a)Has received prior systemic cytotoxic chemotherapy for metastatic disease
- •b)Has received antineoplastic biological therapy (e.g., erlotinib, crizotinib,
- •c)Had major surgery <3 weeks prior to first dose, •Received radiation
- •therapy to the lung that is >30 Gy within 6 months of the first dose of
- •trial treatment, •Completed palliative radiotherapy within 7 days of the first
- •dose of trial treatment, •Is Expected to require any other form of
- •antineoplastic therapy while on study, • Has Received a live-virus vaccination
- •within 30 days of planned treatment start. Seasonal flu vaccines that do not
- •contain live virus are permitted., •Has clinically active diverticulitis,
- •intra-abdominal abscess, GI obstruction, abdominal carcinomatosis, •Has a known
- •history of prior malignancy except if the patient has undergone potentially
- •curative therapy with no evidence of that disease recurrence for 5 years since
- •initiation of that therapy., • Has known active central nervous system (CNS)
- •metastases and/or carcinomatous meningitis. Subjects with previously treated
- •brain metastases may participate provided they are clinically stable for at
- •least 2 weeks and, have no evidence of new or enlarging brain metastases and
- •also are off steroids 3 days prior to dosing with study medication. Stable
- •brain metastases by this definition should be established prior to the first
- •dose of study medication. Subjects with known untreated asymptomatic brain
- •metastases may participate but will require regular imaging of the brain as a
- •site of disease., •Previously had a severe hypersensitivity reaction to
- •treatment with another mAb., •Has a known sensitivity to any component of
- •cisplatin, carboplatin or pemetrexed, •Has active autoimmune disease that has
- •required systemic treatment in past 2 years (i.e. with use of disease modifying
- •agents, corticosteroids or immunosuppressive drugs). Replacement therapy
- •(e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy
- •for adrenal or pituitary insufficiency, etc.) is not considered a form of
- •systemic treatment., •Is on chronic systemic steroids. Subjects with asthma
- •that require intermittent use of bronchodilators, inhaled steroids, or local
- •steroid injections would not be excluded from the study., •Is unable to
- •interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other
- •than an aspirin dose <= 1.3 g per day, for a 5-day period (8-day period for
- •long-acting agents, such as piroxicam)., •Is unable or unwilling to take folic
- •acid or vitamin B12 supplementation., •Had prior treatment with any other
- •anti-PD-1, or PD-L1 or PD-L2 agent or an antibody targeting other
- •immuno-regulatory receptors or mechanisms. Has participated in any other
- •MK-3475 trial and has been treated with MK-3475., Examples of such antibodies
- •include (but are not limited to) antibodies against ID
研究者
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