FMT+Immunotherapy+Chemotherapy as First-line Treatment for Driver-gene Negative Advanced NSCLC

Non-small Cell Lung Cancer Clinical Trial

Official title: Fecal Microbiota Transplantation Combined With Immunotherapy and Chemotherapy as First-line Treatment for Driver-gene Negative Advanced Non-small Cell Lung Cancer: a Prospective, Multicenter, Single-arm Exploratory Study (FMT-JSNO-02)

Status Not yet recruiting

Clinical Trial Summary

This study plans to reconstruct intestinal microecology through fecal microbiota transplantation (FMT), and combine first-line standard therapy to enhance the anti-tumor immune effect at the same time, thereby extending the progression-free survival of patients and improving the prognosis of patients.

Clinical Trial Description

This is a prospective, single-arm, multicenter, exploratory clinical study. That is, eligible patients with driver-gene negative, ECOG PS 0-1, PD-L1<50% advanced non-small cell lung cancer who have not received prior treatment will be screened after signing informed consent and receive FMT combined with tislelizumab + pemetrexed and platinum-based therapy (for adenocarcinoma patients) / albumin-bound paclitaxel and platinum-based therapy (for squamous cell carcinoma patients). RECIST v1.1 was used for tumor evaluation every 6 weeks during treatment. NCI-CTCAE 5.0 was used for safety assessment every 3 weeks. Adverse events were recorded throughout the study to 30 days after the end of treatment. Treatment continues until disease progression, subject withdraws informed consent, loss of follow-up, or death. Patients should provide 10ml whole blood samples and fecal samples at baseline, after two cycles of treatment, before maintenance treatment, and after two cycles of maintenance treatment for the detection of efficacy prediction markers (each cycle is 21 days). ;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

• NCT number: NCT06403111
• Study type: Interventional
• Source: Changzhou No.2 People's Hospital
• Contact: Hua Jiang, MD
• Phone: +86-18015852711
• Email: czeyjh@njmu.edu.cn
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 1, 2024
• Completion date: June 1, 2026