Observational research to decide optimal dose of Afatinib in patients with primary lung adenocarcinoma harbouring the sensitive mutation of epidermal growth factor receptor (EGFR) by pharmacokinetic analyses

Observational research to decide optimal dose of Afatinib in patients with primary lung adenocarcinoma harbouring the sensitive mutation of epidermal growth factor receptor (EGFR) by pharmacokinetic analyses - Observational research to decide optimal dose of Afatinib by pharmacokinetic analyses

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000033549

Enrollment

Registered

2018-08-01

Start date

2018-10-30

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

Patients have primary lung adenocarcinoma harbouring the sensitive mutation of epidermal growth factor receptor (EGFR)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Histologically or cytologically proven lung adenocarcinoma 2)Stage IIIB/IV(UICC ver.8) or recurrence after surgical treatment 3)Tumor has sensitive mutation for EGFR-TKI 4)Naive treatment of EGFR-TKI 5)Tumor has the evaluable lesion 6)Eastern Cooperative Oncology Group performance status of 0-2 7)Age; > or = 20 years and < 80 years 8) No history of thoracic irradiation 9)Adequate organ function, Adequate organ function Neutrocyte count; > or = 1,500/mm3 Hemoglobin concentration; > or = 10.0g/dl Platelet count; > or = 100,000/mm3 Total bilirubin level; < or = 2.0 mg/dl Aspartate aminotransferse and alanine aminotransferase levels; < or = 100 IU/L Creatinine clearance; > or = 30mL/min Or serum creatinine; < or = 1.5 mg/dl SpO2 at room air; > or = 70 torr at room air 10)Neither overt interstitial pneumonia nor overt lung fibrosis 11)Written informed consent

Exclusion criteria

Exclusion criteria: Exclusion criteria included: 1)Uncontrollable comorbid disease. 2)Symptomatic brain metastases 3)Active concomitant malignancy 4)Active infectious disease 5)Pregnant status or lactation 6)Acute or chronic diarrhea 7)Clinically active interstitial pneumonia 8)Acute myocardial ischemia within 3 months or unstable angina pectoris 9)Other ineligible status judged by medical oncologist

Design outcomes

Primary

Measure	Time frame
To seek the pharmacological optimal dose of Afatinib in patients with primary lung adenocarcinoma harbouring the sensitive mutation of EGFR by pharmacokinetic analyses	—

Secondary

Measure	Time frame
To seek the clinical optimal dose of Afatinib: Progression free survival (PFS),Time to Treatment failure (TTF), Health states evaluation; time with toxicity more than Grade 2 (TOX-G2), 20% duration of TOX-G2 among PFS (20% TOX-G2; TOX20). To examine the relationship between the efficacy of Afatinib and the copy number of EGFR mutation	—

Countries

Japan

Contacts

Public ContactYuichiro Takeda

National Center for Global Health and Medicine Department of Respiratory Medicine / Laboratory Testing Department

ytakeda@hosp.ncgm.go.jp+81332027181

Outcome results