A phase II study of first-line gefitinib for advanced and recurrent EGFR mutation positivenon-small cell lung cancerwith high-risk factors

A phase II study of first-line gefitinib for advanced and recurrent EGFR mutation positivenon-small cell lung cancerwith high-risk factors - A phase II study of first-line gefitinib for advanced and recurrent EGFR mutation positivenon-small cell lung cancerwith high-risk factors

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004822

Enrollment

Registered

2011-01-05

Start date

2010-10-01

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

non-small cell lung cancer

Interventions

Gefitinib(250mg), oral daily

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)histologically or cytologically confirmed non-small cell lung cancer 2)unresectable, stage III or IV disease and radical radiotherapy unable 3)possess measurable lesion 4)EGFR mutation positive 5)20 years old or over 6)naive to chemotherapy for lung cancer 7)naive to radiotherapy for primally lung cancer 8)preserved organ's function WBC>=2,000/mm3 Hemoglobin>= 7.0g/dl Platelet count>=75,000/mm3 Total serum bilirubin <=1.5 mg/dl GOT/GPT <100 IU/l Serum creatinine <=1.5mg/dl 9)written informed consent and applicable to 1 or 2 risk factors below 10)ECOG Perfomance status 2 -3 11)75 years old or over 12)evident pleural effusion 13)symptomatic brain or osseous metastasis 14)metastasis in more than two organs

Exclusion criteria

Exclusion criteria: 1)ECOG Perfomance Status 4 2)white blood cell count; less than 2,000/mm3 3)bsolute neutrophil count; less than 1,000/mm3 4)hemoglobin; less than 7.0 g/dL 5)platelet count; less than 75,000/mm3 6)serum total bilirubin; 1.5 mg/dL or over 7)AST/ALT; 100 IU/L or over 8)serum creatinine; 1.5 mg/dL or over 9)serious complications below I)uncontrollable angina pectoris, myocardial infarction within 6 months or heart failure II)serious heart dosease III)uncontrollable diabetes or hypertension IV)infection 10)pulmonary fibrosis or interstitial pneumonitis evident on chest X ray 11)now pregnant or lactation, or possible pregnancy or refusal of contraception 12)difficult to perform or continue of this study

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
safety, progression-free survival, overall survival	—

Countries

Japan

Contacts

Public ContactShuji Murakami

Kanagawa Cancer Center Department of Thoracic Oncology

murakamis@kcch.jp045-520-2222

Outcome results

None listed

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