Study: NCT04872634

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: SNK01 (Super Natural Killer Cells 01)
Description: 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.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: SNK01 (Super Natural Killer Cells 01)
Description: 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.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: SNK01 (Super Natural Killer Cells 01)
Description: 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.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: SNK01 (Super Natural Killer Cells 01)
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GC
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GC
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GC
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GC
Description: 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.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Cetuximab
Description: 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

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Cetuximab
Description: 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