Phase II study to prove the validity of Hange-shashin-to for diarrhea by Afatinib in EGFR mutation-positive non-small cell lung cancer

Phase II study to prove the validity of Hange-shashin-to for diarrhea by Afatinib in EGFR mutation-positive non-small cell lung cancer - Phase II study to prove the validity of Hange-shashin-to for diarrhea by Afatinib in EGFR mutation-positive non-small cell lung cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000017750

Enrollment

Registered

2015-06-01

Start date

2015-06-01

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

EGFR mutation-positive non-small cell lung cancer

Interventions

Hange-shashin-to

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Histologically confirmed non-squamous cell lung cancer (2)Stage IV or recurrent NSCLC (3)Harboring sensitive EGFR mutation (4)Patients who are scheduled for administration of Afatinib (5)20 years or older (6)Performance Status (ECOG) 0-2 (7)Having adequate organ functions (8) Estimated life expectancy at least 3 months (9)With written informed consent

Exclusion criteria

Exclusion criteria: (1)Having problematic interstitial lung disease or lung fibrosis on chest CT (2)Having severe organ dysfunction (3)Having sever malabsorption syndrome or gastrointestinal dysfunction as follows, after total gastrectomy, active peptic ulcer, active inflammatory bowel disease (4)Pregnant women, or having possibility of pregnancy; man having no intent to birth control (5)In addition to the above, any contraindications to Afatinib or Hange-shashin-to (6)Having active gastrointestinal tumor (7)In addition, the primary doctor judging inappropriate for entry

Design outcomes

Primary

Measure	Time frame
Onset of Grade 2 more diarrhea within 28 days by Afatinib	—

Countries

Japan

Contacts

Public ContactOu Yamaguchi

Saitama Medical University International Medical Center respiratory medicine

ouyamaguchi@gmail.com042-984-4111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026