None listed
Conditions
Interventions
Descripcion de la Intervencion(es): Forma Farmaceutica, dosis, frecuencia, duracion, via de administracion, grupo de tratamiento (Ingles): Treatment Arms: Arma 1: Pembrolizumab 200 mg fixed dose intra
this retreatment will be the Second Course Phase. Response or progression in the Second Course Phase will not count towards the ORR and PFS endpoints in this trial.
Sponsors
Merck Sharp & Dohme Corp., una subsidiaria de Mer·ck & Co. Inc.,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Criterios de Inclusion: Descripcion (sexo, criterios de diagnostico clinico, condiciones co-morbidas, etc. De realizarse el EC con sujetos sanos, consignar, Voluntarios humanos saludables (Español)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 metastatic NSCLC stage IV Performance status of 0 or 1 (ECOG) Adequate organ function 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 metastatic stage IV 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 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. Is currently participating in or has participated in a trial 4 weeks prior to the first dose of trial treatment. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
Countries
Argentina, Australia, Brazil, Chile, Colombia, France, Germany, Ireland, Italy, Mexico, New Zealand, Poland, Spain, Ukraine, United Kindgdom
Contacts
Public ContactAngie Portocarrero
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed