NCT05008861

Gut Microbiota Reconstruction for NSCLC Immunotherapy

Safety of Gut Microbiota Reconstruction Plus PD-1/PD-L1 Monoclonal Antibodies to Treat Locally Advanced or Metastatic Non-Small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

In this study, patients with locally advanced or metastatic NSCLC after first-line treatment with PD-1/PDL-1 monoclonal antibody will be treated with Gut Microbiota reconstruction(such as FMT) combined with PD-1/PDL-1 monoclonal antibody. We will evaluate the safety of FMT in the treatment of advanced NSCLC, and analyze the effect of FMT on intestinal flora and immunophenotype of patients.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
PROCEDURE	Capsulized Fecal Microbiota Transplant	Capsules contained washed fecal microbiota.
DRUG	Anti-programmed cell death protein 1/programmed death-ligand 1 monoclonal antibody	Standard dose of one of anti-PD-1/PD-L1 mAbs administered as a 1 hour infusion every 3 weeks.
DRUG	Platinum based chemotherapy	Standard dose of Platinum based Chemotherapy every 3 weeks.

Timeline

• Start date: 2021-09-01
• Primary completion: 2022-12-30
• Completion: 2022-12-30
• First posted: 2021-08-17
• Last updated: 2021-08-17

Locations

1 site across 1 country: China