None listed
Conditions
Interventions
Drug : Subjects are randomized in a 1:1 ratio to receive either pembrolizumab monotherapy (experimental arm) or pembrolizumab plus platinum-based chemotherapy (control arm). The treatment regimen cons
Sponsors
Kyung Hee University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult patients aged 19 years or older 2) Patients with histologically or cytologically confirmed stage IV non-small cell lung cancer (NSCLC) who are PD-L1 positive (TPS = 50%) and no EGFR or ALK mutations 3) Patients with no prior experience with cytotoxic chemotherapy or targeted therapy However, patients who experienced recurrence at least 6 months after completing neoadjuvant/adjuvant chemotherapy or definitive chemoradiotherapy may be eligible, except those who failed durvalumab maintenance therapy. 4) Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 ~ 2 5) Patients with Life expectancy = at least 3 months 6) Patients with at least one measurable lesion as defined by RECIST version 1.1 7) Patients with adequate bone marrow reserves or organ function as determined by the following blood test criteria: - Absolute neutrophil count (ANC) = 1,500 x 10^6/L - Platelet count = 100 x 10^9/L - Hemoglobin = 9 g/dL - Serum creatinine = 1.5 x the upper limit of normal (ULN) or estimated creatinine clearance (CrCl, using the Cockcroft-Gault formula) = 45 mL/min; however, if scheduled to receive cisplatin, CrCl must be = 60 mL/min - Total bilirubin = 1.5 xULN; if there is liver metastasis or known Gilbert’s disease, = 3 xULN - Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) = 2.5 xULN; if liver metastasis is present, ALT and AST = 5xULN; if liver or bone metastasis is present, ALP = 5 xULN - Thyroid-stimulating hormone (TSH) within normal limits 8) Female patients of childbearing potential with a negative urine or serum pregnancy test at screening 9) Female patients of childbearing potential or male patients with female partners of childbearing potential who agree to use effective contraception during the study treatment period and for at least 6 months after the last dose of the study drug 10) Patients who have received detailed information about the study, fully understand it, and voluntarily decide to participate with written informed consent
Exclusion criteria
Exclusion criteria: 1) Patients diagnosed with another primary cancer that could affect non-small cell lung cancer (NSCLC) within the past 5 years Exceptions include effectively treated non-melanoma skin cancer, cervical carcinoma in situ, ductal carcinoma in situ of the breast, thyroid cancer, or malignancies effectively treated and considered cured after maintaining remission for over 3 years 2) Patients receiving systemic glucocorticoids (with the exception of steroid replacement therapy equivalent to prednisone doses of 5-7.5 mg) or other immunosuppressive therapy 3) Patients who have received more than 30 Gy of thoracic radiotherapy within 6 months prior to the first dose 4) Patients with untreated active central nervous system (CNS) metastases and/or carcinomatous meningitis Patients are eligible if they meet the following conditions: - CNS metastases have been treated, and the patient shows radiographic and neurological stability prior to enrollment - Patients with asymptomatic CNS metastases 5) Patients with active autoimmune disease requiring systemic treatment within the past 2 years 6) Patients with active interstitial lung disease requiring steroid treatment However, patients receiving low-dose steroids (prednisone =10 mg/day or equivalent doses of corticosteroid therapy for 7 consecutive days) may be eligible at the investigator's discretion 7) Patients with pneumonia requiring intravenous antibiotics 8) Patients with uncontrolled cardiovascular disease within 6 months prior to enrollment, including severe heart failure, unstable angina, uncontrolled arrhythmias, or a history of life-threatening arrhythmias 9) Patients with active infections requiring hospitalization or treatment, including HBV, HCV, or active tuberculosis 10) Patients who are pregnant or breastfeeding 11) Patients with a known hypersensitivity to the investigational drug or its components 12) Patients who have received another investigational drug within 30 days prior to the first dose of the study drug 13) Patients deemed unsuitable for study participation by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival, PFS | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS;ORR, Objective response rate;DOR, Duration of response;Safety profile | — |
Countries
Korea, Republic of
Contacts
Public ContactSeung Hyeun Lee
Kyung Hee University Hospital
Outcome results
None listed