KCT0006109
Recruiting
未知
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)
KMAX0 sites24 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- KMAX
- Enrollment
- 24
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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