EUCTR2012-004391-19-ES进行中（未招募）1 期
A Phase II/III Randomized Trial of Two Doses of MK-3475 (SCH900475) versus Docetaxel in Previously Treated Subjects with Squamous Histology Non-Small Cell Lung Cancer
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., (Merck)0 个研究点目标入组 1,034 人开始时间: 2013年3月1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
- 1,034
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
- •1)Be willing and able to provide written informed consent/assent for the trial.
- •2)Be ?18 years of age on day of signing informed consent.
- •3)Have a life expectancy of at least 3 months.
- •4)Have a histologically or cytologically confirmed diagnosis of squamous cell non-small cell lung cancer (NSCLC) and have at least one measurable lesion as defined by RECIST 1.1. For those subjects whose tumors have a mixed histologic component of squamous and another histology, they will be considered eligible for this protocol.
- •5)Have experienced investigator determined radiographic progression per RECIST 1.1 of SCC NSCLC after treatment with a platinum-containing doublet for stage IIIB/IV or recurrent disease. The site?s study team must have reviewed pre-trial images that are of diagnostic quality from at least 2 dates to confirm that radiographic progression has occurred per RECIST 1.1 following initiation of the first-line platinum-containing doublet. The central imaging vendor must have received these scans prior to randomization in this trial for a possible retrospective analysis of this eligibility criterion. The central vendor will not be confirming eligibility prior to randomization. Completion of treatment with a platinum-containing doublet as adjuvant therapy within one year of signing informed consent will satisfy the prior treatment requirement.
- •6)Have a performance status of 0 or 1 on the ECOG Performance Scale.
- •7)Have provided tissue for biomarker analysis from an archival tissue sample or fresh biopsy of a tumor lesion not previously irradiated. Tissue sample must be received by the central vendor prior to randomization.
- •8)Have resolution of toxic effect(s) of the most recent prior chemotherapy to Grade 1 or less (except alopecia). If subject received major surgery or radiation therapy of > 30 Gy, they must have recovered from the toxicity and/or complications from the intervention.
- •Refer to Protocol for the complete list.
- •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 245
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 163
排除标准
- •1)Is known to have an EGFR mutation or the AML4-ALK translocation.
- •2)Has received prior therapy with docetaxel for NSCLC.
- •3)Is receiving systemic steroid therapy within three days prior to the first dose of trial treatment or receiving any other form of immunosuppressive medication (corticosteroid use on study for management of ECI-ies or as a pre-medication for docetaxel is allowed).
- •4)Is expected to require any other form of systemic or localized antineoplastic therapy while on trial (including maintenance therapy with another agent for NSCLC or radiation therapy).
- •5)Has received maintenance chemotherapy (chemotherapy for subjects with a stable or better response to the prior line of treatment) with an additional agent other than that used in the first-line regimen (switch maintenance).
- •6)Has received prior systemic cytotoxic chemotherapy, biological therapy (e.g., cetuximab), major surgery or received radiation therapy of > 30 Gy within 3 weeks of the first dose of trial treatment; received prior kinase inhibitor therapy or palliative radiotherapy of 30Gy or less within 7 days of the first dose of trial treatment.
- •7)Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
- •8)Has a known history of prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or in situ cervical cancer, and has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
- •-Note: The time requirement for no evidence of disease for 5 years does not apply to the tumor for which a subject is enrolled in the trial. 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, or in situ cervical cancer.
- •9)Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by MRI for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are using no steroids for at least three days prior to study medication..
- •10)Has an active autoimmune disease, or a documented history of autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement will not be excluded from the study.
- •11)Has interstitial lung disease.
- •12)Has symptomatic ascites or pleural effusion. A subject who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.
- •13)Has an active infection requiring intravenous systemic therapy.
- •14)Has known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- •15)Has known active Hepatitis B or C.
- •Refer to Protocol for the
研究者
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