A study to evaluate the safety and anti-tumor activity of SNK01 (NK Cells) administered in combination with chemotherapy or chemotherapy/cetuximab in local advanced or metastatic non-small cell lung cancer patients who failed tyrosine kinase inhibitor treatment
- Conditions
- Neoplasms
- Registration Number
- KCT0006109
- Lead Sponsor
- KMAX
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
(1)histologically or cytologically diagnosed with Locally advanced or Metastatic Non-small Cell Lung Cancer (TNM 8th edition). However, recurrent Non-small Cell Lung Cancer is also allowed.
(2)Those who have one or more gene mutations among EGFR, ALK, and ROS1
(3)Those who have been TKI treated for EGFR, ALK, or ROS1 gene mutation at least once or whose progressive disease is confirmed during or after completion of the treatment
?Only the patients for whom effective targeted therapy (allowed by the insurance standard) is exhausted can be enrolled in the study.
?For example, the patients for whom a T790M mutation has been confirmed after administration of EGFR TKIs (gefinitib erlotinib, afatinib) are not allowed to be enrolled before administration of osimertinib.
?The patients who have a T790M mutation but have failed in EGFR TKIs (gefinitib, erlotinib, afatinib) and osimertinib treatments are allowed to be enrolled.
(4)Those who have undergone platinum based chemotherapy (excluding Gemcitabine), other chemotherapy or immunotherapy besides TKI treatment before. (Those who have undergone neoadjuvant chemotherapy or adjuvant chemotherapy are also allowed.)
(5)Those whose remaining toxicity resulting from previous anti-cancer therapy is grade 1 or lower in accordance with CTCAE V5.0.
However, those who suffer from alopecia not lower than grade 2 or neuropathy of grade 2 related to previous platinum based chemotherapy are allowed to be enrolled.
(6)Those who have voluntarily decided to participate in the present clinical trial and put their signature on a subject’s consent form before start of the trial
(7)Those who are 20 years of age or older
(8)Those who have at least one lesion measurable by RECIST v1.1
(9)Those whose life expectancy is 3 months or longer
(10) Those whose Eastern Collaborative Oncology Group (ECOG) performance status is 0 or 1 when screened
(11) Those who have adequate blood and terminal organ functions defined by the following laboratory test result secured within 28 days prior the enrollment:
?ANC = 1,500 cells/µL (1.5 X 109/L)
?WBC count > 3,500 cells/µL
?Platelet = 100,000 cells/ µL
?Hemoglobin = 10.0 g/dL
?AST, ALT, alkaline phosphatase = 2.5 X (ULN). However, 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
However, the patients whose total bilirubin is not higher than 3 X ULN among the patients who have a known Gilbert disease are allowed to be enrolled.
?Serum creatinine <1.5 X ULN or creatinine clearance = 50 mL/min (calculated by the Cockcroft-Gault formula)
(12) For fertile women: Those who have agreed to maintain abstinence (refraining from sextual intercourses with men) or use a contraceptive measure of which the annual failure rate is lower than 1 % during the treatment period and for minimum 6 months (180 days) after the last administration of SNK01, GC, or Cetuximab.
Women who have had their first menstrual period, not yet reached a post-menopausal state (amenorrhea for longer than 12 months in succession without cause other than menopause) and have not undergone surgical sterilization (ovariectomy or hysterectomy) and under the age of 55 with follicle stimulating hormone (FSH) levels of less than 40 mIU/mL are considered as fertile women. However, women who have already confirmed menopause are excluded.
The examples
Subjects who fulfill ANY of the following criteria will not be enrolled into the study:
(1)Those who have taken a drug for another clinical trial or participated in another clinical trial within 30 days prior to the enrollment
(2)Those who have taken Cetuximab to cure Non-Small Cell Lung Cancer
(3)Those for whom a systemic or partial antineoplastic therapy is scheduled during the period of the present study
(4)Those whose previous treatments meet the following criteria:
?Those who have undergone systemic Cytotoxic Chemotherapy, administration of a biologic agent, or a surgery within 3 weeks prior to the enrollment date
?Those who have undergone Breast Radiotherapy of which the radiation exceeds 30 gray (Gy) for treatment of Non-small Cell Lung Cancer within 6 months prior to the enrollment date
?Those who have undergone Palliative Radiotherapy on the regions to which a lung cancer is metastasized (bone, brain, etc.) within 1 week before the enrollment date
?Those who have undergone therapy of EGFR TKIs (Gefitinib, Erlotinib, Afatinib, Osimertinib, etc.), ALK TKIs (Crizotinib, Ceretinib, Alectinib, Brigatinib, etc.) and/or ROS1 TKIs (Crizotinib, etc.) within 2 weeks of the enrollment date
(5)Those who have an anamnesis of a known allergic reaction or a serious allergic reaction to Gemcitabine, Carboplatin, or another platinum containing compound, Cetuximab or a monoclonal antibody
(6)Those who have uncured or active Central Nervous System (CNS) metastasis confirmed by screening and previous CT or MRI evaluation. However, the patients who have cured or symptomless CNS metastasis are allowed to be enrolled if they meet all the following criteria:
?if a lesion exists on the region other than the area of CNS metastasis that can be evaluated or measured by RECIST V1.1;
?if it is radiologically confirmed before the enrollment that the lesion is stabilized after the area of CNS metastasis has been treated;
?if the patients have no anamnesis of intracranial hemorrhage or myelorrhagia; and
?if the patients have clinically stable symptomless lesion for minimum 2 weeks after treatment of the CNS metastasis and stopping use of anticonvulsant or steroid.
(7)Those who have had an active autoimmune disorder within 2 years prior to the enrollment date which requires systemic treatment
(8)Those who have undergone allogeneic stem cell or solid-organ transplant before
(9)Those who have an interstitial lung disease or pneumonitis which requires orally or intravenously administered steroid treatment
(10)Those who have been inoculated or plan to be inoculated with live attenuated influenza vaccine within 30 days prior to the enrollment date
(11)Those who have an active infection that requires systemic treatment through intravenous administration
(12)Those who have been tested positive for HIV, HBV, or HCV
(13)Those who have a medical history related to psychiatry or an anamnesis of drug abuse or alcoholism that will affect participation in the present clinical trial
(14)Those who have an anamnesis of another malignant tumor within recent 5 years.
However, patients with a non-melanoma skin carcinoma appropriately treated or with another cancer that shows no evidence of the disease after receiving potential treatment and for which no evidence of recurrence is found for 5 years from the starting point of the treatment by the doctor in charge are allowed to be enr
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse events, physical examination, laboratory test ;Progression-Free Survival (PFS), Disease Control Rate (DCR), Objective Response Rate (ORR), Time to Progression (TTP), Duration of Response (DoR), Quality of Life
- Secondary Outcome Measures
Name Time Method K cell activity test (NK Vue® Kit), Analysis of changes in immunocytes and Cytokine