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)

Merck Sharp & Dohme LLC., (una subsidiaria de Merck & Co. Inc.),0 个研究点目标入组 25 人开始时间: 2015年2月13日最近更新: 2023年9月4日

试验速览

暂无简介。

•At least one radiographically measurable lesion per RECIST 1.1.
•Be ≥18 years of age
•Life expectancy of at least 3 months
•Not received prior systemic chemotherapy treatment for their advanced/metastatic NSCLC
•Performance status of 0 or 1 (ECOG)
•Adequate organ function
•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
•Provided formalin fixed tumor tissue from a biopsy of a tumor lesion AFTER the diagnosis of metastatic disease has been made AND from a site not previously irradiate
•Histologically or cytologically confirmed diagnosis of advanced or metastatic
•Have a PD-L1 positive tumor as determined by IHC
•Female subjects must have a negative urine or serum pregnancy test if of childbearing potential or be of non-child bearing potential.
•Heterosexually active women are willing to use two methods of birth control (which is also recommended for the female partners of male subjects). The two birth control methods can be either two barrier methods or a barrier method plus a hormonal method to prevent pregnancy. Subjects should start using birth control from study Visit 1 throughout the study period up to 120 days after the last dose of pembrolizumab and up to 180 days after last dose of chemotherapeutic agents or TKIs
•Voluntarily agreed to participate by giving written informed consent

•EGFR sensitizing mutation and/or is EML4/ALK fusion positive
•Tumor specimen is not evaluable for PD-L1 expression
•Subjects with squamous histology who received carboplatin in combination with paclitaxel
•Is receiving systemic steroid therapy < 3 days prior to the first study dose
•NSCLC can be treated with curative intent with either surgical resection and/or chemo-radiation
•Expected to require any other form of systemic or localized antineoplastic therapy while on trial
•Received any prior systemic cytotoxic chemotherapy, biological therapy major surgery within 3week of first study dose: radiation therapy of > 30 Gy within 6 months of the first dose; received palliative radiotherapy of 30Gy or less within 7 days of the first dose.
•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
•Known central nervous system metastases and/or carcinomatous meningitis
•Had an allogeneic tissue/solid organ transplant
•Active infection, or autoinmune disease
•Known history of Human Immunodeficiency Virus, pneumonitis or active Hepatits B or C
•Pregnant or breastfeeding, or expecting to conceive or father children

发起方

Merck Sharp & Dohme LLC., (una subsidiaria de Merck & Co. Inc.),