EUCTR2014-001473-14-PL进行中（未招募）1 期
A Randomized, Open Label, Phase III Study of Overall Survival Comparing Pembrolizumab (MK-3475) versus Platinum Based Chemotherapy in Treatment Naïve Subjects with PD-L1 Positive Advanced or Metastatic Non-Small Cell Lung Cancer (Keynote 042) - OS study of Pembrolizumab vs. SOC in 1L subjects with PD-L1 Positive Advanced or Metastatic NSCLC
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
- 1,250
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 measurable disease based on RECIST 1.1. as determined by the site.
- •Be =18 years of age on the day of signing informed consent.
- •Have a life expectancy of at least 3 months.
- •Have not received prior systemic chemotherapy treatment for their advanced/metastatic NSCLC. Treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of advanced or metastatic disease.
- •Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status
- •Have adequate organ function.
- •Have no 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, or have undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
- •Have provided formalin fixed tumor tissue sample from a biopsy of a tumor lesion either at the time of or after the diagnosis of advanced or metastatic disease has been made AND from a site not previously irradiated to assess for PD-L1 status. Biopsies obtained PRIOR to the administration of any systemic therapy administered for the treatment of a subject’s tumor (such as adjuvant therapy) will not permitted for analysis. The tissue sample must be received by the central vendor prior to randomization. Fine needle aspirates are not acceptable. Core needle or excisional biopsies, or resected tissue is required.
- •Have a histologically or cytologically confirmed diagnosis of advanced or metastatic, NSCLC and not have an EGFR sensitizing (activating) mutation or an ALK translocation. EGFR sensitizing mutations are those mutations that are amenable to treatment with TKIs including erlotinib, gefitinib or afatanib. Investigators must be able to produce the source documentation of the EGFR mutation and ALK translocation in all subjects with non-squamous histologies AND for subjects in whom testing is clinically recommended. If either an EGFR sensitizing mutation or ALK translocation is detected, additional information regarding the mutation status of the other molecule is not required. If documentation is unavailable or the site is unable to test for these molecular changes, formalin fixed paraffin embedded tumor tissue of any age should be submitted to a central laboratory designated by the Sponsor for such testing. Subjects with non-squamous histologies will not be randomized until EGFR mutation status and/or ALK translocation status is available in source documentation at the site.
- •Have a PD-L1 positive tumor (TPS=1%) as determined by IHC at a central laboratory; only PD-L1 positive subjects (TPS=1%) will be randomized. If the tumor specimen is not evaluable for PD-L1 expression by the central laboratory, the subject is not eligible to participate in the study.
- •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 875
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 375
排除标准
- •Has an EGFR sensitizing mutation and/or ALK translocation. For patients enrolled who are known to have a tumor of predominantly squamous histology, molecular testing for EGFR mutation and ALK translocation will not be required as this is not standard of care and is not part of current diagnostic guidelines.
- •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 of the first dose of trial treatment.
- •Tumor specimen is not evaluable for PD-L1 expression by the central laboratory. If an additional tumor specimen is submitted AND evaluable for PD-L1 expression, the subject will be eligible to participate if PD-L1 expression is assessed as positive (TPS=1%) by the central laboratory.
- •Subjects with squamous histology who received carboplatin in combination with paclitaxel in the adjuvant setting.
- •Is receiving systemic steroid therapy < 3 days prior to the first dose of trial treatment or receiving any other form of immunosuppressive medication.
- •a. Corticosteroid use on study after Cycle 1 for management of AEs, SAEs and ECIs, as a pre-medication for the control chemotherapies, as a pre-medication for IV contrast allergies/reactions or if considered necessary for a subject’s welfare is allowed.
- •b. Subjects who receive daily steroid replacement therapy serve as an exception to this rule. Daily prednisone at doses of 5-7.5 mg is an example of replacement therapy.
- •c. Equivalent hydrocortisone doses are also permitted if administered as a replacement therapy.
- •The subject’s NSCLC can be treated with curative intent with either surgical resection and/or chemoradiation
- •Is expected to require any other form of systemic or localized antineoplastic therapy while on trial (including maintenance therapy with another agent for NSCLC, radiation therapy, and/or surgical resection).
- •Has received any prior systemic cytotoxic chemotherapy, biological therapy OR had major surgery within 3 weeks of the first dose of trial treatment; received lung radiation therapy of > 30 Gy within 6 months of the first dose of trial treatment.
- •Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic 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).
- •Has known central nervous system metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are clinically stable (neurologically asymptomatic) and have no evidence of new or enlarging brain metastasis by imaging at least 4 weeks after treatment of the brain metastases (e.g. surgery, RT) and are off steroids for at least 3 days prior to the first dose of study medication.
- •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 (i.e., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Subjects that require inhaled corticosteroids would not be excluded from the study. Subjects with vitiligo or resolved childhood asthma/atopy would not be excluded from the study. Subjects that require local steroid i
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