Table 2. Clinical trials of manipulation of the gut microbiome on lung cancer (recruiting or completed).
| Trial number | Patient population | Intervention | Outcomes | Status (country/region) |
|---|---|---|---|---|
| NCT02771470 | Lung cancer | Drug: probiotics | Composition of microorganisms in stool after probiotic intervention; frequency and severity of adverse effects during chemotherapy; the change of immunity and nutrition index | Completed (China) |
| NCT04056026 | Mesothelioma | Fecal microbiota transplant | Primary: PFS | Completed (United States) |
| NCT03637803 | Solid tumor, NSCLC, RCC, melanoma, bladder cancer | MRx0518 with pembrolizumab | Primary: safety and tolerability of MRx0518 in combination with pembrolizumab; clinical benefit of MRx0518 in combination with pembrolizumab; secondary: antitumor effect | Recruiting (United States) |
| NCT04601402 | Solid tumor, NSCLC, head and neck, urothelial carcinoma | GEN-001 with avelumab | Primary: safety; secondary: efficacy | Recruiting (United States) |
| NCT04699721 | NSCLC Stage III | Nivolumab + paclitaxel + carboplatin + BiFico (Bifidobacterium trifidum live powder) | Primary: safety, surgical complications; secondary: efficacy (ORR, recurrence rate, DFS, OS) | Recruiting (China) |
| NCT04857697 | Breast cancer, lung cancer | Oral probiotics | Primary: length of probiotics, adherence of probiotics, percentage of CD8+, CD4+, and T-reg cells, cytokine counts | Recruiting (China) |
| NCT04909034 | Lung cancer | MS20 | Primary: the incidence of treatment-emergent adverse event; secondary: ORR, PFS, DCR, DOR | Recruiting (Taiwan) |
| NCT04924374 | Lung cancer | Dietary supplement: microbiota transplant plus anti-PD-1 therapy | Primary: safety; secondary: efficacy (iRECIST) | Recruiting (Spain) |
| NCT05094167 | NSCLC | Lactobacillus Bifidobacterium V9 (Kex02) with combined carilizumab with platinum chemotherapy | Primary: ORR; secondary: PFS, OS | Recruiting (China) |
NSCLC, non-small cell lung cancer; RCC, renal cell carcinoma; PD-1, programmed death 1; PFS, progression-free survival; ORR, overall response rate; DFS, disease-free survival; OS, overall survival; DCR, disease control rate; DOR, duration of response; iRECIST, immune response evaluation criteria in solid tumors.