EUCTR2014-005060-15-LV进行中（未招募）1 期
A Phase III open-label, multicenter trial of avelumab (MSB0010718C) versus docetaxel in subjects with non-small cell lung cancer that has progressed after a platinum-containing doublet
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
- Merck KGaA
- 入组人数
- 650
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
入选标准
- •- Signed written informed consent before any trial related procedure
- •- Male or female subjects aged = 18 years
- •- Availability of a formalin-fixed, paraffin-embedded block containing tumor tissue or 7 unstained tumor slides suitable for PD-L1 expression assessment
- •- Tumor determined to be evaluable for PD-L1 expression per the evaluation of a central laboratory
- •- Subjects with histologically confirmed Stage IIIb/IV or recurrent NSCLC who have experienced disease progression
- •- Subjects must have progressed after an acceptable therapy defined as follows:
- •a. Subjects must have progressed during or after a minimum of 2 cycles of 1 course of a platinum based combination therapy administered for the treatment of a metastatic disease. A history of continuation (use of a non platinum agent from initial combination) or switch (use of a different agent) maintenance therapy is permitted provided there was no progression after the initial combination. A switch of agents during treatment for the management of toxicities is also permitted provided there was no progression after the initial combination
- •b. Subjects must have progressed within 6 months of completion of a platinum-based adjuvant, neoadjuvant, or definitive chemotherapy, or concomitant chemoradiation regimen for locally advanced disease
- •- Subjects with non-squamous cell NSCLC of unknown EGFR mutation status will require testing (local laboratory, or central laboratory if local testing is not available). Subjects with a tumor that harbors an activating EGFR mutation will not be eligible (see Exclusion Criterion 3)
- •- ECOG PS of 0 to 1 at trial entry
- •- Estimated life expectancy of more than 12 weeks
- •- Adequate hematological function defined by WBC count = 2.5 × 109/L with absolute neutrophil count (ANC) = 1.5 × 109/L, lymphocyte count = 0.5 × 109/L, platelet count = 100 × 109/L, and hemoglobin = 9 g/dL (may have been transfused)
- •- Adequate hepatic function defined by a total bilirubin level = 1.5 × the upper limit of normal (ULN) range and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels = 2.5 × ULN for all subjects
- •- Adequate renal function defined by an estimated creatinine clearance > 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method)
- •Other protocol defined criteria could apply
- •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 455
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 195
排除标准
- •Exclusion criteria
- •- In the United States only, subjects with a squamous cell histology will be excluded
- •- Systemic anticancer therapy administered after disease progression during or following a platinum based combination
- •- Subjects with non-squamous cell NSCLC whose
- •disease harbors EGFR mutation(s) and / or anaplastic lymphoma kinase (ALK) rearrangement will not be eligible for this trial. Subjects of unknown ALK and / or
- •EGFR mutation status will require testing at screening (local laboratory, or central laboratory if local testing is not available)
- •- Prior therapy with any antibody/drug targeting T cell coregulatory proteins (immune checkpoints) such as PD-1, PD L1, or cytotoxic T lymphocyte antigen-4 (CTLA-4).
- •- Concurrent anticancer treatment
- •- Major surgery for any reason, except diagnostic biopsy, within 4 weeks of randomization and/or if the subject has not fully recovered from the surgery within 4 weeks of randomization
- •- Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of the trial treatment.
- •- All subjects with brain metastases, except those meeting the following criteria:
- •a. Brain metastases have been treated locally, and
- •b. No ongoing neurological symptoms that are related to the brain localization of the disease
- •- Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent:
- •a. Subjects with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible
- •b. Subjects requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses = 10 mg equivalent prednisone per day
- •c. Administration of steroids through a route known to result in a minimal systemic exposure are acceptable
- •- Previous or ongoing administration of systemic steroids for the management of an acute allergic phenomenon is acceptable as long as it is anticipated that the administration of steroids will be completed in 14 days, or that the daily dose after 14 days will be = 10 mg per day of equivalent prednisone
- •Other protocol defined criteria could apply
研究者
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