EUCTR2015-003694-15-FR进行中（未招募）1 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).
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 570
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
- 性别
- All
入选标准
- •Have a histologically-confirmed or cytologically-confirmed diagnosis of stage IV (M1a or M1b AJCC 7th edition) non-squamous NSCLC.
- •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 lesions.
- •Have not received prior systemic treatment for their advanced/metastatic NSCLC. Subjects who received adjuvant therapy are eligible if the adjuvant 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.
- •Life expectancy of at least 3 months.
- •ECOG performance status of 0 or 1
- •Have adequate organ function as indicated by in the protocol specified laboratory values
- •If female of childbearing potential (Section 5.7.2), 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 (Section 5.7.2), be willing to use an adequate
- •method of contraception as outlined in Section 5.7.2-Contraception, 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.
- •Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for
- •the subject.
- •If male subject with a female partner(s) of child-bearing potential, must agree to use
- •an adequate method of contraception as outlined in Section 5.7.2-Contraception,
- •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.
- •Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for
- •the subject.
- •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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 302
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 268
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 patient is ineligible.
- •Before the first dose of trial treatment:
- •a)Has received prior systems cytotoxic chemotherapy for metastatic disease
- •b)Has received antineoplastic biological therapy (e.g., erlotinib, crizotinib, cetuximab)
- •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
- •Expected to require any other form of antineoplastic therapy while on study
- •Received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.
- •Clinically active diverticulitis, intra-abdominal abscess, GI obstruction, abdominal carcinomatosis
- •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 the therapy.
- •Note: The time requirement for no evidence of disease for 5 years does not apply to the NSCLC tumor for which a subject is enrolled in the study. The time requirement also does not apply to subjects who underwent successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers.
- •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. Patients with 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 IDO, PD-L1, IL-2R, GITR
- •Has an active infection re
研究者
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