Observation study of the relationship between intestinal bacterial flora and therapeutic effect or adverse events on advanced non-small cell lung cancer patients treated with nivolumab.

Observation study of the relationship between intestinal bacterial flora and therapeutic effect or adverse events on advanced non-small cell lung cancer patients treated with nivolumab. - Observation study of the relationship between bacterial flora and effect or AEs on NSCLC patients treated with nivolumab.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000026375

Enrollment

Registered

2017-03-02

Start date

2017-03-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small-Cell Lung Cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Histologically or cytologically proven non-small cell lung cancer 2)Pretreated NSCLC, without immune chekpoint inhibitor 3)ECOG PS : 0-2 4)When taking lactobacillus preparation (including marketing medicines), it can be canceled from one week before registration to the end of observation period. 5)At least one measurable lesion by RECIST 6)Life expectancy more than 12 weeks. 7)Written informed consent. 8)Patients who have had the following administration periods from the previous treatment A.chemotherapy:Not specified B.radiation chest: >4weeks Other than chest: >2 weeks C.surgery major: >4weeks minor: >2weeks

Exclusion criteria

Exclusion criteria: 1)With active or history of Interstitial pneumonia. 2)Interstitial change or pulmonary fibrosis detectable on X ray 3)Autoimmune disease. 4)Patients receiving corticosteroids (up to 10 mg/day in terms of prednisolone is acceptable) or immunosuppressants within 2 weeks before registration. 5)Patients receiving antibiotics within 5 weeks before registration 6)Patients who are pregnant or nursing 7)With active or history of inflammatory bowel disease. 8)Evaluated to be ineligible by a physician for other reasons.

Design outcomes

Primary

Measure	Time frame
Relationship between intestinal bacterial flora and therapeutic effect of nivolumab.	—

Secondary

Measure	Time frame
Relationship between variation of bacterial flora and therapeutic effect, AEs or PD-L1 expression.	—

Countries

Japan

Contacts

Public ContactRYO ITOTANI

Kitano Hospital Respiratory medicine

itotani@kitano-hp.or.jp06-6312-1221

Outcome results