NCT03642548

Probiotics Combined With Chemotherapy for Patients With Advanced NSCLC

A Prospective Multicenter Double-blind Randomized Clinical Trial of Probiotics Combined With Chemotherapy in the Treatment of Patients With Advanced Non-small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Shanghai 10th People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Based on the theory of intestinal lung axis, the effect of new therapy on patients with advanced NSCLC was observed by adjusting the intestinal micro-ecology and combining existing platinum-based doublet chemotherapy.

Detailed description

OBJECTIVES: Primary outcomes To compare progression free survival (PFS) and objective response rate (ORR) in patients with stage IIIB or IV non-small cell lung cancer receiving Bifico versus placebo plus platinum-based doublet chemotherapy for first-line treatment. Secondary outcomes To compare overall survival (OS) between the two arms； To evaluate the nature, severity, and frequency of toxicities between arms； To correlate the blood markers and fecal microbiome (at diagnosis) with outcomes and response. OUTLINE: This is a randomized, double-blind, placebo-controlled clinical trial. Patients are stratified according to center, performance status (0 or 1), tobacco use (never vs past or present), weight loss (\< 5% vs ≥ 5% or unknown). Patients are randomized to 1 of 2 treatment arms. BIFICO Group: Patients receive Bifico (420mg, 3 times a day, p.o) plus platinum-based doublet chemotherapy. Chemotherapy repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Placebo Group: Patients receive placebo (420mg, 3 times a day, p.o) plus platinum-based doublet chemotherapy. Chemotherapy repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Blood, tissue and fecal samples are collected and examined for biomarkers, gene mutations and fecal microbiome, and may be banked for future studies.

Conditions

• Probiotics Plus Chemotherapy

Interventions

Type	Name	Description
DRUG	bifico	Patients in BIFICO group receive platinum-based doublet chemotherapy for first-line treatment chemotherapy plus Bifico.
DRUG	placebo	Patients in control group receive platinum-based doublet chemotherapy for first-line treatment chemotherapy plus Placebo.

Timeline

• Start date: 2019-02-21
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2018-08-22
• Last updated: 2019-02-25