Non-small Cell Lung CancerPhase 1/2SNK_ASTERNCT04872634
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
A Phase 1/2 study testing SNK01 (Super Natural Killer Cells 01), GC and Cetuximab in people with Non-small Cell Lung Cancer, run by NKMAX Co., Ltd. at 1 site in South Korea.
Trial summary
This clinical trial is a Single-Center, Open, Phase I/IIa Clinical Trial conducted to evaluate the safety and anti-tumor activity of SNK01 and GC +/- Cetuximab administered in combination to Locally advanced or Metastatic Non-small Cell Lung Cancer Patients who have failed prior Tyrosine Kinase Inhibitor (TKI) therapy… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- SNK01 (Super Natural Killer Cells 01), GC and Cetuximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Jul 2021to 26 May 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- one or more gene mutations among EGFR, ALK, and ROS1
- 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
- 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.)
- 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.
- voluntarily decided to participate in the present clinical trial and put their signature on a subject's consent form before start of the trial
Show all 37Show fewer
- 20 years of age or older
- at least one lesion measurable by RECIST v1.1
- life expectancy is 3 months or longer
- Eastern Collaborative Oncology Group (ECOG) performance status is 0 or 1 when screened
- adequate blood and terminal organ functions
- 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 of the contraceptive measures of which the failure rate is lower than 1 % include the following: Bilateral Tubal Ligatio, male sterilization, established and appropriate use of hormonal contraception that inhibits ovulation, hormone releasing IUD (IntraUterine Device) and copper IUD. The reliability of abstinence should be evaluated based on the clinical trial period and the daily life-style preferred by the patient. Periodic abstinence (example: calendar method, ovulation, and post-ovulation body temperature measurement method) and coitus interrupts are not acceptable contraceptive measures.
- For men: Those who have agreed to maintain abstinence (refraining from sextual intercourses with women) as defined below, use contractiptive measures, and abstain from sperm donation. Men with a fertile spouse should maintain abstinence or use of condoms and additional contraceptive measures during the treatment period and for minimum 4 months (120 days) after the last administration of SNK01, GC or Cetuximab so that the annual failure rate is lower than 1 %. Men should abstain from sperm donation during this period. The reliability of sexual abstinence should be evaluated based on the study period and the normal life-style preferred by the patient. Periodic abstinence (example: calendar method, ovulation, and post-ovulation body temperature measurement method) and coitus interrupts are not acceptable contraceptive measures.
- adapt themselves to the Protocol according to the judgment of the investigator
- Exclusion Criteria: Subjects who fulfill ANY of the following criteria will not be enrolled into the study:
- have taken a drug for another clinical trial or participated in another clinical trial within 30 days prior to the enrollment
- have taken Cetuximab to cure Non-Small Cell Lung Cancer
- a systemic or partial antineoplastic therapy is scheduled during the period of the present study
- 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
- 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
- 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.
- an active autoimmune disorder within 2 years prior to the enrollment date which requires systemic treatment
- undergone allogeneic stem cell or solid-organ transplant before
- an interstitial lung disease or pneumonitis which requires orally or intravenously administered steroid treatment
- have been inoculated or plan to be inoculated with live attenuated influenza vaccine within 30 days prior to the enrollment date
- an active infection that requires systemic treatment through intravenous administration
- positive for HIV, HBV, or HCV
- a medical history related to psychiatry or an anamnesis of drug abuse or alcoholism that will affect participation in the present clinical trial
- 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 enrolled.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, Songpa-gu, 05505
Jae Cheol Lee, 02-3010-3208, jclee@amc.seoul.kr
About this study
Official title: A Phase I/IIa, Open, Single-Center Clinical Trial Evaluating the Safety and Anti-Tumor Activity of SNK01 (Natural Killer Cells) Administered in Combination With Gemcitabine/Carboplatin or Gemcitabine/Carboplatin/Cetuximab to Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients Who Have Failed Prior Tyrosine Kinase Inhibitor (TKI) Therapy (SNK_ASTER)
This clinical trial is a Single-Center, Open, Phase I/IIa Clinical Trial conducted to evaluate the safety and anti-tumor activity of SNK01 and GC +/- Cetuximab administered in combination to Locally advanced or Metastatic Non-small Cell Lung Cancer Patients who have failed prior Tyrosine Kinase Inhibitor (TKI) therapy at least once.
After the start of the clinical trial, the first 3 subjects complete the enrollment in Cohort 1 in serial order and then 3 subjects are enrolled in Cohort 2 in serial order. After this, Cohorts 1, 3 and Cohorts 2, 4 are independently processed and subjects are enrolled in serial order when new cohorts start and/or replacement subjects are required. For the subjects who are additionally enrolled after the DLT evaluation and the MTD is determined in each dose cohort, no DLT evaluation is conducted.
Read more
The subjects allotted to each cohort are administered with the SNK01 manufactured from peripheral blood mononuclear cells total 8 times over a period of about 10 weeks. Combined administration of SNK01 starts from the Cycle 2 (Week 4) of Cytotoxic Chemotherapy and SNK01 is administered at an interval of 1 week starting from the day after the administration of Cytotoxic Chemotherapy and/or Cetuximab (Visit 5-1, D23).
When no disease progression is confirmed at EOT (End of Treatment), disease progression is checked until the clinical trial is over. The adverse events which have occurred during the study period are monitored until the date when the investigator judges that no monitoring is required as the symptom has disappeared or there is no further change in the symptom or the 30th day (±3 d) from the latest date of the administration among Gemcitabine, Carboplatin and Cetuximab after the EOT, whichever comes first.
For all the subjects enrolled in the present clinical trial, safety is checked in accordance with CTCAE V5.0 and effectiveness is checked in accordance with RECIST V1.1 through the vital signs, laboratory test, adverse events, etc. during the study period.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- SNK01 (Super Natural Killer Cells 01), GC, Cetuximab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNK01 (Super Natural Killer Cells 01)Biological
Investigational Product : SNK01 (Super Natural Killer Cells 01) Principal Component : Autologous Natural Killer Cell To induce anti-tumor immunity in Locally advanced or Metastatic Non-small Cell Lung Cancer Patients who have failed prior TKI therapy for EGFR, ALK, or ROS1 Gene Mutation and to strengthen the Antibody-Dependent Cellular Cytotoxicity (ADCC) of Cetuximab, 4x10^9 or 6x10^9 cells are infused through the veins of the subjects within 45 minutes (±15 minutes) per 100 mL total 8 times at intervals of one week.
GCDrug
Also called Cytotoxic Chemotherapy
Gemcitabine; 1000mg/m2, Day 1, Day 8, 4-cycle administration, Mixed with normal saline 50ml and administered into a vein for 30 min.
Carboplatin; AUC 5, Day 1, 4-cycle administration, Mixed with 5% Dextrose 200ml and administered into a vein for 1 hour.
CetuximabBiological
First administration: 400mg/m2 Subsequent administration: 250mg/m2 (Premedication before administration*) Weekly Administration continues until the disease progresses or unacceptable toxicity develops.
400mg/m2: Administered into a vein for 120 minutes 250mg/m2: Administered into a vein for 60 minutes
| Study group | Role | What they receive |
|---|---|---|
| SNK01 (4ⅹ10^9 cells) + GC | Experimental | Administration of SNK01 4ⅹ10^9 cells/dose 8 times at an interval of 1 week + Administration of Cytotoxic Chemotherapy (GC) up to 4 cycles at an interval of 3 weeks Receives: Biological: SNK01 (Super Natural Killer Cells 01); Drug: GC |
| SNK01 (4ⅹ10^9 cells) + GC + Cetuximab | Experimental | Administration of SNK01 4ⅹ10^9 cells/dose 8 times at an interval of 1 week + Administration of Cytotoxic Chemotherapy (GC) up to 4 cycles at an interval of 3 weeks + Weekly administration of Cetuximab until the disease progresses or unacceptable toxicity develops Receives: Biological: SNK01 (Super Natural Killer Cells 01); Drug: GC; Biological: Cetuximab |
| SNK01 (6ⅹ10^9 cells) + GC | Experimental | Administration of SNK01 6ⅹ10^9 cells/dose 8 times at an interval of 1 week + Administration of Cytotoxic Chemotherapy (GC) up to 4 cycles at an interval of 3 weeks Receives: Biological: SNK01 (Super Natural Killer Cells 01); Drug: GC |
| SNK01 (6ⅹ10^9 cells) + GC + Cetuximab | Experimental | Administration of SNK01 6ⅹ10^9 cells/dose 8 times at an interval of 1 week + Administration of Cytotoxic Chemotherapy (GC) up to 4 cycles at an interval of 3 weeks + Weekly administration of Cetuximab until the disease progresses or unacceptable toxicity develops Receives: Biological: SNK01 (Super Natural Killer Cells 01); Drug: GC; Biological: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose of the dose of SNK01 + GC + (or Cetuximab)
Dose-Limiting Toxicity assessment
Measured: 28 days
Adverse event
Adverse event (AE)
Measured: Up to 12 months
Secondary outcomes (7)
Progression-free survival
Progression-Free Survival (PFS)
Measured: every 12 weeks, up to the time of death or tumor progression, maximum 24 months
Disease Control Rate
Disease Control Rate (DCR)
Measured: every 12 weeks, up to the time of death or tumor progression, maximum 24 months
objective response rate
objective response rate (ORR)
Measured: every 12 weeks, up to the time of death or tumor progression, maximum 24 months
Time to progression
Time to progression (TTP)
Measured: every 12 weeks, up to the time of death or tumor progression, maximum 24 months
Duration of response
Duration of response (DoR)
Measured: every 12 weeks, up to the time of death or tumor progression, maximum 24 months
QoL
EoRTC QLQ-C30
Measured: every 12 weeks, up to the time of death or tumor progression, maximum 24 months
QoL
EORTC QLQ-LC13
Measured: every 12 weeks, up to the time of death or tumor progression, maximum 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start8 Jul 2021
- Primary completion26 May 2023 (estimated)
- Study completion26 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NKMAX Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872634
- Sponsor's protocol ID
- SNK01_TRN12a
- Acronym
- SNK_ASTER
- Status last verified
- Jul 2021
- First submitted
- 21 Apr 2021
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choi MG, Son GW, Choi MY, Jung JS, Rho JK, Ji W, Yoon BG, Jo JM, Kim YM, Ko DH, Lee JC, Choi CM. Safety and efficacy of SNK01 (autologous natural killer cells) in combination with cytotoxic chemotherapy and/or cetuximab after failure of prior tyrosine kinase inhibitor in non-small cell lung cancer: non-clinical mouse model and phase I/IIa clinical study. J Immunother Cancer. 2024 Mar 27;12(3):e008585. doi: 10.1136/jitc-2023-008585.
PubMed 38538093
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa, Open, Single-Center Clinical Trial Evaluating the Safety and Anti-Tumor Activity of SNK01 (Natural Killer Cells) Administered in Combination With Gemcitabine/Carboplatin or Gemcitabine/Carboplatin/Cetuximab to Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients Who Have Failed Prior Tyrosine Kinase Inhibitor (TKI) Therapy (SNK_ASTER)
- ClinicalTrials.gov ID
- NCT04872634
- Acronym / sponsor ID
- SNK_ASTER / SNK01_TRN12a
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- NKMAX Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Jul 2021 (actual)
- Primary completion
- 26 May 2023 (estimated)
- Study completion
- 26 May 2023 (estimated)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial is a Single-Center, Open, Phase I/IIa Clinical Trial conducted to evaluate the safety and anti-tumor activity of SNK01 and GC +/- Cetuximab administered in combination to Locally advanced or Metastatic Non-small Cell Lung Cancer Patients who have failed prior Tyrosine Kinase Inhibitor (TKI) therapy at least once.
After the start of the clinical trial, the first 3 subjects complete the enrollment in Cohort 1 in serial order and then 3 subjects are enrolled in Cohort 2 in serial order. After this, Cohorts 1, 3 and Cohorts 2, 4 are independently processed and subjects are enrolled in serial order when new cohorts start and/or replacement subjects are required. For the subjects who are additionally enrolled after the DLT evaluation and the MTD is determined in each dose cohort, no DLT evaluation is conducted.
The subjects allotted to each cohort are administered with the SNK01 manufactured from peripheral blood mononuclear cells total 8 times over a period of about 10 weeks. Combined administration of SNK01 starts from the Cycle 2 (Week 4) of Cytotoxic Chemotherapy and SNK01 is administered at an interval of 1 week starting from the day after the administration of Cytotoxic Chemotherapy and/or Cetuximab (Visit 5-1, D23).
When no disease progression is confirmed at EOT (End of Treatment), disease progression is checked until the clinical trial is over. The adverse events which have occurred during the study period are monitored until the date when the investigator judges that no monitoring is required as the symptom has disappeared or there is no further change in the symptom or the 30th day (±3 d) from the latest date of the administration among Gemcitabine, Carboplatin and Cetuximab after the EOT, whichever comes first.
For all the subjects enrolled in the present clinical trial, safety is checked in accordance with CTCAE V5.0 and effectiveness is checked in accordance with RECIST V1.1 through the vital signs, laboratory test, adverse events, etc. during the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SNK01 (4ⅹ10^9 cells) + GC | Experimental | Biological: SNK01 (Super Natural Killer Cells 01), Drug: GCAdministration of SNK01 4ⅹ10^9 cells/dose 8 times at an interval of 1 week + Administration of Cytotoxic Chemotherapy (GC) up to 4 cycles at an interval of 3 weeks |
| SNK01 (4ⅹ10^9 cells) + GC + Cetuximab | Experimental | Biological: SNK01 (Super Natural Killer Cells 01), Drug: GC, Biological: CetuximabAdministration of SNK01 4ⅹ10^9 cells/dose 8 times at an interval of 1 week + Administration of Cytotoxic Chemotherapy (GC) up to 4 cycles at an interval of 3 weeks + Weekly administration of Cetuximab until the disease progresses or unacceptable toxicity develops |
| SNK01 (6ⅹ10^9 cells) + GC | Experimental | Biological: SNK01 (Super Natural Killer Cells 01), Drug: GCAdministration of SNK01 6ⅹ10^9 cells/dose 8 times at an interval of 1 week + Administration of Cytotoxic Chemotherapy (GC) up to 4 cycles at an interval of 3 weeks |
| SNK01 (6ⅹ10^9 cells) + GC + Cetuximab | Experimental | Biological: SNK01 (Super Natural Killer Cells 01), Drug: GC, Biological: CetuximabAdministration of SNK01 6ⅹ10^9 cells/dose 8 times at an interval of 1 week + Administration of Cytotoxic Chemotherapy (GC) up to 4 cycles at an interval of 3 weeks + Weekly administration of Cetuximab until the disease progresses or unacceptable toxicity develops |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (37 listed)
- 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.
- one or more gene mutations among EGFR, ALK, and ROS1
- 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
- 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.)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SNK01 (Super Natural Killer Cells 01)Investigational Product : SNK01 (Super Natural Killer Cells 01) Principal Component : Autologous Natural Killer Cell To induce anti-tumor immunity in Locally advanced or Metastatic Non-small Cell Lung Cancer Patients who have failed prior TKI therapy for EGFR, ALK, or ROS1 Gene Mutation and to strengthen the Antibody-Dependent Cellular Cytotoxicity (ADCC) of Cetuximab, 4x10^9 or 6x10^9 cells are infused through the veins of the subjects within 45 minutes (±15 minutes) per 100 mL total 8 times at intervals of one week. | Biological | SNK01 (4ⅹ10^9 cells) + GC, SNK01 (4ⅹ10^9 cells) + GC + Cetuximab, SNK01 (6ⅹ10^9 cells) + GC, SNK01 (6ⅹ10^9 cells) + GC + Cetuximab |
| GCAlso: Cytotoxic ChemotherapyGemcitabine; 1000mg/m2, Day 1, Day 8, 4-cycle administration, Mixed with normal saline 50ml and administered into a vein for 30 min. Carboplatin; AUC 5, Day 1, 4-cycle administration, Mixed with 5% Dextrose 200ml and administered into a vein for 1 hour. | Drug | SNK01 (4ⅹ10^9 cells) + GC, SNK01 (4ⅹ10^9 cells) + GC + Cetuximab, SNK01 (6ⅹ10^9 cells) + GC, SNK01 (6ⅹ10^9 cells) + GC + Cetuximab |
| CetuximabFirst administration: 400mg/m2 Subsequent administration: 250mg/m2 (Premedication before administration*) Weekly Administration continues until the disease progresses or unacceptable toxicity develops. 400mg/m2: Administered into a vein for 120 minutes 250mg/m2: Administered into a vein for 60 minutes | Biological | SNK01 (4ⅹ10^9 cells) + GC + Cetuximab, SNK01 (6ⅹ10^9 cells) + GC + Cetuximab |
Primary outcome
Maximum Tolerated Dose of the dose of SNK01 + GC + (or Cetuximab)
Time frame: 28 days
Dose-Limiting Toxicity assessment
Adverse event
Time frame: Up to 12 months
Adverse event (AE)
7 secondary outcomes
Progression-free survival
Time frame: every 12 weeks, up to the time of death or tumor progression, maximum 24 months
Disease Control Rate
Time frame: every 12 weeks, up to the time of death or tumor progression, maximum 24 months
objective response rate
Time frame: every 12 weeks, up to the time of death or tumor progression, maximum 24 months
Time to progression
Time frame: every 12 weeks, up to the time of death or tumor progression, maximum 24 months
Duration of response
Time frame: every 12 weeks, up to the time of death or tumor progression, maximum 24 months
QoL
Time frame: every 12 weeks, up to the time of death or tumor progression, maximum 24 months
QoL
Time frame: every 12 weeks, up to the time of death or tumor progression, maximum 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Derived from this study: PubMed 38538093Choi MG, Son GW, Choi MY, Jung JS, Rho JK, Ji W, Yoon BG, Jo JM, Kim YM, Ko DH, Lee JC, Choi CM. Safety and efficacy of SNK01 (autologous natural killer cells) in combination with cytotoxic chemotherapy and/or cetuximab after failure of prior tyrosine kinase inhibitor in non-small cell lung cancer: non-clinical mouse model and phase I/IIa clinical study. J Immunother Cancer. 2024 Mar 27;12(3):e008585. doi: 10.1136/jitc-2023-008585.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SNK01 (Super Natural Killer Cells 01), GC and Cetuximab in people with Non-small Cell Lung Cancer, run by NKMAX Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 37 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose of the dose of SNK01 + GC + (or Cetuximab) (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04872634, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2021.