None listed
Conditions
Interventions
Treatment Gropus
Pembrolizumab (MK-3475) 200 mg intravenous (IV) every 3 weeks (Q3W)
OR
SOC: investigator’s choice of one of the following:
Carboplatin AUC 5 or 6 + paclitaxel 200 mg/m2
Sponsors
Merck Sharp & Dohme LLC., (una subsidiaria de Merck & Co. Inc.),
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 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
Countries
Argentina, Canada, China, Colombia, Czech Republic, Guatemala, Japan, Korea South, Latvia, Lithuania, Malasya, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, South Africa, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, Vietnam
Contacts
Public ContactNelva Garcia
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed