EUCTR2018-003791-12-IT进行中（未招募）1 期
A Phase 3, multicenter, randomized, open-label trial to compare the efficacy and safety of pembrolizumab (MK-3475) in combination with lenvatinib (E7080/MK-7902) versus docetaxel in previously treated participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and immunotherapy (anti-PD-1/PD-L1 inhibitor) (LEAP-008) -
MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.0 个研究点目标入组 391 人开始时间: 2021年1月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 391
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
- •1Hav histolog or cytolog confirm diagnosis metastatic squamous or nonsquamous NSCLC
- •2Hav PD treat antiPD1/PDL1mAb administer either as monoth or in combinat with other checkpoint inhibitors or other therapies.Anti PD1/PDL1 treat progression is defined by meeting ALL of follow criteria:
- •Treat with at least 2 doses of an antiPD1/PDL1 mAb
- •PD after antiPD1/PDL1 mAb defin byRECISTv1.1The initial evidence of PD confirm by second assess no less than4weeks from date of first documented PD,in absence rapid clinical progression
- •PD docum within12weeks from last dose antiPD1/PDL1 mAb
- •3Hav PD during/after platinum doublet chemother
- •4Hav confirm that EGFR-, ALK-, or ROS1-direther is not indic primary ther(docum absence of tumoractiv EGFR mutats[DEL19oL858R],absence ofALKandROS1gene rearrangements OR presence of Kras mutat)
- •5Hav submit prestudy imaging that confirm evidence of PD bas on investigator review at least2images per RECIST 1.1,follow init of an antiPD1/PDL1 inhibitor
- •6Hav measurable disease bas on RECIST 1.1as determ by local site assessment.
- •Hav at least1measurable lesion byCTorMRI per RECIST 1.1
- •7Hav provided tumor tissue for PDL1 biomarker analysis from an archival sample(defin: from initial diagnosis ofNSCLC and prior to receiving immunother [antiPD-1/PD-L1],from primary lesion or metastatic lesion)
- •8Hav provid prior to alloc tissue from newly obtain formalinfix sample from new biopsy(defi as: after compl of immunoth[anti-PD-1/PD-L1]and before rece an allocation number),of tumor lesion not previously irradiated
- •9Be>=18 years of age day of signing the ICF
- •10Hav ECOG perform status of0or1within3days before first dose study interv but before allocation
- •11Hav life expect least3months
- •12Male participants rece pembrolizumab±lenvatinib or lenvatinib are eligible participate they agree to the follow during the interv period and for at least 120 days after the last dose study interv:
- •Male participants random docetaxel are eligible partic if they agree follow during intervention period and for at least 180 days after the last dose of docetaxel:Refrain from donating sperm
- •PLUS either:Be abstinent from heterosexual intercourse as their prefer and usual lifestyle(abstinent on a longterm and persistent basis)and agree to remain abstinent.
- •OR Must agree to use contrac unless confirm to be azoospermic (vasect or secondary to medical cause)
- •Agree to use a male condom plus partner use of add contrace method when having penilevaginal intercourse with a WOCBP who is not currently pregnant
- •13A female parti is eligible to participate if she isnot pregnant or breastfe and at least 1 the following cond applies:
- •Is not WOCBP OR Is WOCBP and using contrac meth that is highly effective(with failure rateof<1%year), with low user dependency, or abstinent from heterosexual intercourse as her pref and usual lifestyle (abstinent on a long term and persistent basis)dur interv period and for at least120days after the last dose of study inter,and agrees not to donate eggs(ova, oocytes)others or freeze/store these for her own use for the purpose of reprod dur this period
- •WOCBPrandom to docetaxel is eligible participate if she is using contraceptive method that is highly effective with low user dependency or is abstinent from heterosexual intercourse as her preferred and usual lifestyle and agrees not donate or freeze/store eggs during the intervention period and for at least180days after last dose of docetaxel
- •WOCBPmust hav negative highly sensitive pregnancy test(uri
排除标准
- •1Has receiv docetaxel as monother or combin with other therap
- •2Has receiv lenvatinib as monother or combin with an antiPD1/PDL1 inhibitor
- •3Has receiv radiotherapy within 2 weeks before the first dose of study interv or has receiv lung radiat therapy >30 Gy within 6 months before the first dose of study interv
- •4Has receiv a live vaccine within 30 days before the first dose of study interv
- •5Has clinically significant hemoptysis (at least 0.5 teaspoon of bright red blood) or tumor bleeding within 2 weeks before the first dose of study interv
- •6Has radiographic evidence of major blood vessel invasion/infiltration
- •7Has clinically significant cardiovascular impairment within 12months of the first dose of study interv, such as history of congestive heart failure greater than New York Heart Assoc Class II, unstable angina, myocardial infarction or cerebrovascular accident/transient ischemic attack(TIA)/stroke, cardiac revascularization, or cardiac arrhythmia associated with hemodynamic instability
- •8Has a history of a gastrointstinal condition or procedure that,opinion of the investigator, may affect oral study interv absorption
- •9Is a WOCBP who has a positive urine pregnancy test within 72 hours before allocation
- •10Is currently participating in a clinical trial and receiving study therapy or participated in a study of an investigational agent within 4 weeks of the first dose of study interv
- •11Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (exceeding 10 mg of prednisone or equivalent daily) or any other form of immunosuppressive therapy within 7 days before the first dose of study interv
- •12Has a known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of disease recurrence for 3 years since initiation of that therapy
- •13Has known active central nervous system metastases and/or carcinomatous meningitis
- •14Has severe hypersensitivity (Grade>=3) to pembrolizumab and/or any of its excipients
- •15Has sensitivity to any of the excipients contained in lenvatinib
- •16Has sensitivity to any of the excipients contained in docetaxel
- •17Has active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs)
- •18Has history of (noninfectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease
- •19Has an active infection requiring systemic therapy
- •20Has known history of human immunodeficiency virus (HIV) infection
- •21Has known history of hepatitis B (defined as hepatitis B surface antigen (HBsAg) reactive or known active hepatitisCvirus (HCV)(defin as HCV RNA [qualitative] is detected) infection
- •22Has known history of active tuberculosis
- •23. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study or interfere with the participant's participation for the full duration of the study, or it is not in the best interest of the participant to participate, in the opinion of the treating investigator
- •24. Has a known psychiatric or substance abuse disorder that would interfere with the participant’s ability to cooperate with the requirements of the study
- •25. Has a left ventricular ejection fraction (LVEF) below the institutional normal range, as determined by multigated acquisition (MUGA) or echocardiogram (ECHO)
- •26. Has QT interval corrected with Friderici
研究者
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