non-small cell lung cancer PD-L1 high-expressing non-small-cell lung cancer
Conditions
Interventions
Participants receive necitumumab 800mg on day 1 and 8 on day 1 and pembrolizumab 200 mg of each 21-day cycle for up to 35 cycles.
Sponsors
Horiike Atsushi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: We determine patients who are obtained document agreement by free will after the explanation using informed consent form, satisfy all of the following selection criteria, do not conflict with exclusion criteria, have been judged to be eligible for participation in this study by the research doctor as subjects. 1) Histologically confirmed advanced non-small cell lung cancer 2) PD-L1 expression in more than 50% of tumor cells as determined by immunohistochemistry 3) Lacking epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) translocation 4) Measurable lesion by RECIST ver1.1 5) Performance status 0 to 1 (ECOG) 6) Age at agreement acquisition is over 20 years old 7) Life expectancy is at least 3 months 8) Adequate organ function
Exclusion criteria
Exclusion criteria: We exclude persons who corresponding to any of the following criteria from this study. 1) Medical history that may have an impact on the evaluation and safety of this study (heart, liver, kidney, lung , blood disorder etc.) 2) History or complication of autoimmune disease 3) Continuously using systemic corticosteroid 4) Pericardial, pleural effusion or ascites to need drainage 5) Pregnant or lactating women, or men and women with wanting pregnancy 6) Persons who has been judged unsuitable as subjects of this study by the research doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival Overall Survival | — |
Contacts
Public ContactAtsushi Horiike
Showa University Hospital
Outcome results
None listed