Evaluating the Safety and Anti-Tumor Activity of SNK01 (Natural Killer Cells) Plus Pembrolizumab in Patients with Stage IV Non-Small Cell Lung Cancer Who Failed First-Line Platinum-Based Chemotherapy
- Conditions
- Neoplasms
- Registration Number
- KCT0003463
- Lead Sponsor
- KMAX
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 18
1) Persons histologically or cytologically diagnosed with stage IV (TNM 8th edition) non-small cell lung cancer
2) Persons confirmed with progress of disease during or after the completion of platinum-based chemotherapy on non-small cell lung cancer prior to issuing of the enrollment number
3) Persons without EGFR and/or ALK mutation. Except, persons with EGFR and/or ALK mutation but was administered with an approved medicine for these mutations prior to participating in this clinical trial but the progress of the disease has been confirmed during and/or after the completion
4) Persons with below grade 1 of toxicity remaining from the previous chemotherapy according to CTCAE V5.0
Provided, persons with hair loss above grade 2 and grade 2 neuropathy related to the previous platinum-based chemotherapy may be enrolled.
5) Persons decided to participate in this clinical trial in advance at its own decision and signed the trial patient consent form
6) Persons over the age of 20
7) Persons with at least 1 measurable lesion by RECIST v1.1
8) Persons with more than 3 months of life expectancy
9) Persons with 0 or 1 eastern collaborative oncology group (ECOG) performance status during the screening
10) Persons with appropriate blood and polus organ function, as defined by the following lab test results, obtained within 28 days prior to leukapheresis:
- ANC = 1,500 cells/µL (1.5 X 109/L)
- WBC count > 3,500 cells/µL
- Lymphocyte = 300 cells/ µL
- Platelet = 100,000 cells/ µL
- Hemoglobin = 10.0 g/dL
- AST, ALT, alkaline phosphatase = 2.5 X Upper limit of normal (ULN). Provided, patients with liver metastasis: AST and ALT = 5 X ULN.
Patients with liver or bone metastasis: alkaline phosphatase = 5 X ULN.
- Total bilirubin = 1.5 X ULN
Provided, patients with total bilirubin of = 3 X ULN, among the patients with known Gilbert’s syndrome, may be enrolled.
- Serum creatinine < 1.5 X ULN or creatinine clearance = 50 mL/min (Value calculated with Cockcroft-Gault formula)
11) Persons with positive PD-L1 expression from the IHC test
12) Persons consenting to maintaining abstinence (refrain from sexual intercourse with the opposite sex) or using contraceptives
13) Persons able to conform to the protocol as determined by the investigator
1) Persons receiving other Investigational Product or participated in other clinical trials for treatment purposes within 30 days prior to the enrollment number issuance date
2) Persons who have never received systemic chemotherapy for the stage IV non-small cell lung cancer
3) Persons who have received cancer immunotherapy treatment for the stage IV non-small cell lung cancer
4) Persons without a previous confirmed PD-L1 expression results or persons with tumor issues that cannot verify the PD-L1 expression
5) Persons expected to require administration of systemic corticosteroid or other systemic immunosuppressant within 2 weeks of enrollment number issuance or systemic immunosuppressant during the clinical trial period
Persons acutely administered with low-dose systemic immunosuppressant may be enrolled for this clinical trial as determined by the investigator. Use of inhaled corticosteroid, glucocorticoid of physiologically substituted dose (meaning, for adrenal insufficiency) and mineral corticoid (example: fludrocortisone) are permitted.
6) Persons administered with systemic immunostimulant (including, but not limited to, interferon or IL-2) within 4 weeks of the enrollment number issuance date or within 5-times the half-life of the medicine (the shorter of the two)
7) Persons expected to receive systemic or localized antineoplastic treatment during this clinical trial period
8) Persons applicable to the following criteria on the previous treatments
? Persons who have received systemic cytotoxic chemotherapy, biological therapy or surgical procedures within 3 weeks of the enrollment number issuance date;
? Persons who have received chest radiation treatment exceeding 30 gray (Gy) for the treatment of non-small cell lung cancer within 6 months from the enrollment number issuance date;
? Persons who have received palliative radiotherapy on the lung cancer metastasized parts (bone, brain, etc.) within 1 week of the enrollment number issuance date;
? Persons who have received EGFR TKIs and/or ALK TKIs treatments within 2 weeks of the enrollment number issuance date
9) Persons with untreated or active central nervous system (CNS) metastasis that were confirmed from the screening and previous CT or MRI evaluation. Provided, patients with CNS metastasis that are treated or without symptoms may be enrolled when fulfill all of the following criteria:
? Existence of a disease that can be evaluated or measures by RECIST V1.1 in parts other than CNS
? Images prove that the disease has improved after the completion of the targeted therapy on the CNS, and there are no evidence showing the disease has progressed, through images, to the CNS from the tumor evaluation during the screening
? No intracranial hemorrhage or myelorrhagia anamnesis
? After the CNS metastasis treatment and after suspending the use of anticonvulsant or steroid, clinical stable asymptomatic lesion for at least 2 weeks or more
10) Persons with active autoimmune disease requiring systemic treatment within 2 years from the enrollment number issuance date
11) Persons receiving allogeneic stem cell or solid organ transplant in the past
12) Persons with interstitial lung disease or pneumonitis requiring oral or intravenous administration of steroids
13) Persons received or expected to receive attenuated live vaccine within 30 days from the enrollment number issuance date
14) Persons with active infection requiring systemic intravenous treatment
15) Persons with positive
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse Events (CTCAE V5.0 basis), clinical laboratory tests, physical examination, ECG;Progression Free Survival
- Secondary Outcome Measures
Name Time Method Overall Survival Rate, Time to Progression, Objective Response Rate, Quality of Life (EORTC QLQ-C30, EORTC QLQ-LC13), Analysis of Changes in Immunocyte and Cytokine (Chemokine), Immune Cell Activity Test