Poop pills may help revive immunotherapy in lung cancer patients

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * DONOR ① Subjects who have voluntarily provided written Informed consent to participate in this clinical trial ② Aged of 19 or older ③ Subjects who meet one of the following criteria: 1. Patients with histologically confirmed NSCLC who have maintained a clinical benefit(partial response, PR) for more than 1 year through immune checkpoint inhibitor therapy 2. Healthy volunteers with no history of inflammatory bowel disease ④ Subjects who agree to provide repetitive blood and fecal samples during the trial period * RECIPIENT * Have voluntarily provided written Informed consent to participate in this clinical trial * Adults aged 19 years or older * Histologically or cytologically confirmed progressive or metastatic NSCLC * Subjects with at least one measurable lesion according to RECIST v1.1 * Subjects who have received one or more chemotherapy treatments and have experienced disease progression after prior immunotherapy (However, patients with confirmed EGFR or ALK mutations must have shown progression after approved targeted therapies.) * ECOG 0-1 * Subjects with a life expectancy is at least 3 months ⑧ Subjects with adequate bone marrow and organ function within 14 days prior to study treatment, defined as: 1. Absolute neutrophil count (ANC): ≥ 1.5×109/L 2. Hemoglobin: ≥ 9.0 g/dL 3. Platelet count: ≥ 75×109/L 4. Serum creatinine ≤ 1.5×ULN or CrCl ≥ 30 mL/min as determined by Cockcroft-Gault 5. AST(SGOT)/ALT(SGPT): ≤ 3×ULN (≤ 5×ULN in the presence of liver metastases) 6. Total bilirubin: ≤ 1.5×ULN (\< 3×ULN for Gilbert's syndrome(unconjugated hyperbilirubinemia) or liver metastases) ⑨ Female Subjects must be using a highly effective method of contraception during the clinical trial and for 4months after permanent discontinuation of the study drug ⑩ Male Subjects must be using highly effective method of contraception during the clinical trial and for 4months after permanent discontinuation of the study drug and refrain from sperm donation ⑪ Agreed to provide blood and fecal samples during the trial period Exclusion Criteria: * DONOR * Have voluntarily provided written Informed consent to participate in this clinical trial * Adults aged 19 years or older * Histologically or cytologically confirmed progressive or metastatic NSCLC * Subjects with at least one measurable lesion according to RECIST v1.1 * Subjects who have received one or more chemotherapy treatments and have experienced disease progression after prior immunotherapy (However, patients with confirmed EGFR or ALK mutations must have shown progression after approved targeted therapies.) ⑥ ECOG 0-1 * Subjects with a life expectancy is at least 3 months * Subjects with adequate bone marrow and organ function within 14 days prior to study treatment, defined as: 1. Absolute neutrophil count (ANC): ≥ 1.5×109/L 2. Hemoglobin: ≥ 9.0 g/dL 3. Platelet count: ≥ 75×109/L 4. Serum creatinine ≤ 1.5×ULN or CrCl ≥ 30 mL/min as determined by Cockcroft-Gault 5. AST(SGOT)/ALT(SGPT): ≤ 3×ULN (≤ 5×ULN in the presence of liver metastases) 6. Total bilirubin: ≤ 1.5×ULN (\< 3×ULN for Gilbert's syndrome(unconjugated hyperbilirubinemia) or liver metastases) * Female Subjects must be using a highly effective method of contraception during the clinical trial and for 4months after permanent discontinuation of the study drug * Male Subjects must be using highly effective method of contraception during the clinical trial and for 4months after permanent discontinuation of the study drug and refrain from sperm donation * Agreed to provide blood and fecal samples during the trial period * RECIPIENT * Have voluntarily provided written Informed consent to participate in this clinical trial * Adults aged 19 years or older * Histologically or cytologically confirmed progressive or metastatic NSCLC * Subjects with at least one measurable lesion according to RECIST v1.1 * Subjects who have received one or more chemotherapy treatments and have experienced disease progression after prior immunotherapy (However, patients with confirmed EGFR or ALK mutations must have shown progression after approved targeted therapies.) * ECOG 0-1 ⑦ Subjects with a life expectancy is at least 3 months * Subjects with adequate bone marrow and organ function within 14 days prior to study treatment, defined as: 1. Absolute neutrophil count (ANC): ≥ 1.5×109/L 2. Hemoglobin: ≥ 9.0 g/dL 3. Platelet count: ≥ 75×109/L 4. Serum creatinine ≤ 1.5×ULN or CrCl ≥ 30 mL/min as determined by Cockcroft-Gault 5. AST(SGOT)/ALT(SGPT): ≤ 3×ULN (≤ 5×ULN in the presence of liver metastases) 6. Total bilirubin: ≤ 1.5×ULN (\< 3×ULN for Gilbert's syndrome(unconjugated hyperbilirubinemia) or liver metastases) * Female Subjects must be using a highly effective method of contraception during the clinical trial and for 4months after permanent discontinuation of the study drug ⑩ Male Subjects must be using highly effective method of contraception during the clinical trial and for 4months after permanent discontinuation of the study drug and refrain from sperm donation * Agreed to provide blood and fecal samples during the trial period