A Study Evaluating Bacillus Cereus in the Prevention of Afatinib-associated Diarrhea
Status:
Terminated
Trial end date:
2020-12-31
Target enrollment:
Participant gender:
Summary
Afatinib is an irreversible ErbB-family blocker with approved clinical activity in
non-small-cell lung cancer (NSCLC) with EGFR mutations. It has received regulatory approval
for use as a treatment for patients with lung adenocarcinoma whose tumors harbour activating
EGFR mutations within exons 18-21 of the EGFR receptor, or patients with lung squamous cell
carcinoma whose disease progress after platinum-based doublet chemotherapy. However, diarrhea
is the most commonly reported adverse events associated with afatinib treatment (> 90%).
Although these events are generally mild to moderate in severity, diarrhea adversely affects
the tolerability of cancer treatment, and in severe cases diarrhea has the potential to
affect the efficacy of treatment due to poor compliance, or treatment interruption, or dosage
reduction. Currently, no prophylactic measure was demonstrated efficaciously. Bacillus cereus
is an aerobic spore-forming bacterium that is commonly found in soil. The efficacy of
Bacillus cereus in the management of afatinib treatment-associated diarrhoea has not been
extensively evaluated in clinical studies. This is a single-arm, single-institutional, phase
II study evaluating the efficacy and safety of Bacillus cereus (Changfukang®) in the
prevention of afatinib-associated diarrhea in NSCLC patients.