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Dose-escalation Study of Afatinib in Elderly Patients with EGFR mutation for Non-Small Cell Lung Cancer

Dose-escalation Study of Afatinib in Elderly Patients with EGFR mutation for Non-Small Cell Lung Cancer - Dose-escalation Study of Afatinib in Elderly Patients with EGFR mutation for Non-Small Cell Lung Cancer

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000016441
Enrollment
18
Registered
2015-02-04
Start date
2015-02-04
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

afatinib

Sponsors

Hirosaki University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Histologically or cytologically proven non-small cell lung cancer 2)Harboring sensitive EGFR mutation 3)More taan 3 weeks from prior chomotherapy 4)More than 12 weeks from the RT therapy 5)More than 2 weeks from pleurodesis 6)Performance status: 0-1 7)More than 75 years old 8)Adequate organ functions 9)PaO2 >= 60torr or SpO2 >= 95% at room air 10)Life expectancy: over 3 months 11)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Having severe complications 2)Symptomatic brain metastases 3)Interstitial pneumonitis on chest Xray 4)Past history of severe allergic reactions to drugs 5)Pregnant or breastfeeding woman 6)Receiving steroids or immunosuppressants 7)Active infectious disease 8)Uncontrollable pleural effusion or pericardial effusion 9)Active double cancer 10)Patients whose physicians considered as inappropriate for this clinical study

Design outcomes

Primary

MeasureTime frame
To conclude maximum tolerated dose and recommended phase II dose.

Countries

Japan

Contacts

Public ContactHisashi Tanaka

Hirosaki University Graduate School of Medicine Cardiology, Respiratory medicine and Nephrology

xyghx335@gmail.com0172-39-5057

Outcome results

None listed

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