Phase I / II study for appropriate dose of Erlotinib in patients with lung adenocarcinoma having the sensitive mutation to epidermal growth factor receptor (EGFR) - tyrosine kinase inhibitor (TKI)

Phase I / II study for appropriate dose of Erlotinib in patients with lung adenocarcinoma having the sensitive mutation to epidermal growth factor receptor (EGFR) - tyrosine kinase inhibitor (TKI) - Phase I / II study for reduced dose of Erlotinib

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005556

Enrollment

Registered

2011-05-10

Start date

2010-12-01

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

Lung adenocarcinoma having the sensitive mutation to EGFR-TKI

Interventions

Phase I

Dose reduction is guided following a Continual Reassessment Method (CRM) based on effect and toxicity. Starting dose of erlotinib is decided by the dose reduction plan. Evaluation of efficacy and to

Minimum effective dose determined by phase I study is given at day 1. Patients are not given erlotinib but carefully observed in day 2. Pharamacokinetics of erlotinib is performed from day 1 to 2. E

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Histologically or cytologically proven lung adenocarcinoma 2)Stage IIIB/IV(UICC ver.7) 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)Adequate organ function, Adequate organ function Leukocyte count; > or = 3,000/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 PaO2; > or = 70 torr at room air 9)Neither overt interstitial pneumonia nor overt lung fibrosis 10)Written informed consent

Exclusion criteria

Exclusion criteria: 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
1) Phase I; To find the minimum effective dose(MED) of Erlotinib 2) Phase II; The rates of DC(Disease Control) without growth on the MED after 6 to 8 weeks later.	—

Secondary

Measure	Time frame
1)Phase I; Adverse effects on the MED 2)Phase II; QOL questionnaires, pharmacokinetics, progression free survival (PFS), and the rates of adverse effects and response on the MED	—

Countries

Japan

Contacts

Public ContactYuichiro Takeda

National Center for Global health and Medicine Department of Respiratory Medicine

ytakeda@hosp.ncgm.go.jp03-3202-7181

Outcome results

None listed

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