Multi-Center observational study to evaluate the relationship between the status of lung/oral flora and therapeutic efficacy of afatinib for EGFR mutated non-small cell lung cancers

Multi-Center observational study to evaluate the relationship between the status of lung/oral flora and therapeutic efficacy of afatinib for EGFR mutated non-small cell lung cancers - observational study to evaluate the relationship between the status of lung/oral flora and therapeutic efficacy of afatinib

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000036622

Enrollment

Registered

2019-05-10

Start date

2019-05-10

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

lung cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: advanced or relapsed non small cell lung cancer patients

Exclusion criteria

Exclusion criteria: 1 Duplicate cancer of active 2 Autoimmune disease 3 Severe lung disease(ILD IPF) 4 Infections requiring systemic treatment 5 Serious psychiatric disorders 6 Symptomatic brain metastasis 7 Control poor diabetes 8 Control poor disease(heart disease lung disease liver disease kidney disease) 9 Active Hepatitis (type B virus or type C virus) 10 Systemic steroid administration 11 Pregnant women lactating women or women with a positive pregnancy test A woman without intention to contraception A woman wishing to become pregnant or breastfeeding 12 Drug hypersensitivity 13 Cases the attending physician determines that inappropriate to participate in the study

Design outcomes

Primary

Measure	Time frame
Identification of body flora correlated with the tumor response	—

Secondary

Measure	Time frame
Correlation between the disease control rate and the body flora and PBMC Correlation between the progression-free survival and the body flora and PBMC Correlation between the overall survival andthe body flora and PBMC Safety	—

Countries

Japan

Contacts

Public ContactHISASHI TANAKA

Hirosaki Universitiy Graduate school of medicine respiratory medicine

xyghx335@gmail.com0172395468

Outcome results