Review Article

Lung and Gut Microbiota as Potential Hidden Driver of Immunotherapy Efficacy in Lung Cancer

Table 1

Clinical trials investigating the role of microbiota in lung cancer patients receiving immunotherapy.

ClinicalTrial.gov identifierTitleConditionsStudy typeIntervention/treatmentEstimated enrollment (patients)Primary outcomeSecondary outcome

NCT03688347Microbiome in lung cancer and other malignanciesLung cancer and other solid tumorsObservationalNasal, skin, and oral swab, stool collection, and microbiota analysis40Identify and compare bacteria within given samples through a standard protocol and 16S rRNA amplicon; correlate data from samples with patient clinical information regarding overall response ratesCorrelate data from samples with patient clinical information regarding overall response rates

NCT03934827MRx0518 in patients with solid tumours waiting surgical removal of the tumourLung cancer and other solid tumorsPhase 1MRx0518 vs. placebo capsules120Safety and tolerability of MRx0518 as determined through the collection of the number and severity of AEs, SAEs, changes in biochemistry, haematology, urinalysis laboratory results, and vital signsResponse of MRx0518 determined by the measurement of tumor markers; OS of patients who receive MRx0518 compared to placebo

NCT03168464Radiation and immune checkpoints blockade in metastatic NSCLC (BMS # CA209-632)Metastatic NSCLCPhase 1, 2Nivolumab, ipilimumab, and radiation therapy45Enhance ORR to the combination of nivolumab/ipilimumab in chemorefractory NSCLC and double the ORR of ipilimumab/RT, from 18% based on intent to treat to 36%Changes in TCR repertoire in peripheral blood are associated with response to treatment; serum markers IFN-b, CXCL11, sMICA, sMICB levels/changes associated with patients’ response to the treatment; PFS; OS; associations of ORR with changes in the microbiome

vs.: versus; AEs: adverse events; SAEs: serious adverse events; OS: overall survival; NSCLC: non-small-cell lung cancer; ORR: overall response rate; RT: radiotherapy; TCR: T cell receptor; PFS: progression-free survival.