A phase 2 Study of the efficay and safty of erlotinib therapy for 3/4 stage EGFR gene mutation positive EGFR-TKI untreated non-small cell lung cancer

A phase 2 Study of the efficay and safty of erlotinib therapy for 3/4 stage EGFR gene mutation positive EGFR-TKI untreated non-small cell lung cancer - A phase 2 Study of the efficay and safty of erlotinib therapy for 3/4 stage EGFR gene mutation positive EGFR-TKI untreated non-small cell lung cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011986

Enrollment

Registered

2013-10-08

Start date

2013-08-31

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-squamous non-small cell lung cancer

Interventions

Erlotinib 150mg/day

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)stage III/IV non-squamous non-small cell lung cancer 2) EGFR gene mutation positive 3) Prior treatment of chemoradiotherapy or chemotherapy for non-small cell lung cancer patients for up to 1 regimen in the EGFR-TKI untreated 4)20 years or older 5)PS:0-2 (ECOG) 6)at least one measurable leision (RECIST) 7)patients who has the following periods *the last prior chemotherapy:3weeks *whole-brain irradiation(WBRT):2weeks *stereotactic irradiation(SRI):1day *irradiation of bone metastases:1day *palliative radiotherapy:2weeks *operation(surgery without lobectomy):4weeks *operation(endoscopic surgery without lobectomy):2weeks *biopsy with incision, port custody, and treatment to injury:1week *pleurodesis:2weeks *chest drainage:1weeks 8)adequate bone marrow,liver,and renal functions *Neutrophil counts >= 1,500/mm3 *Platelets >= 100,000/mm3 *Hemoglobin concentration >= 9.0g/dL *AST and ALT, x 2.5 of upper limit of normal (ULN) or less *Total bilirubin <= 1.5mg/dL *Serum creatinin, x 1.5mg/dL of ULN or less *SpO2(Room air) >=90% * PT-INR < 1.5 *Protein urea <= 1+ 9)a life expectancy of 3 months or more 10)written informed consent

Exclusion criteria

Exclusion criteria: 1)Pulmonary disorder(idiopathic pulmonary fibrosis,interstitial lung disease, pneumoconiosis, active radiation pneumonia, etc.). 2)known EGFR-TKI resistance gene mutation(T790M) positive 3)history of erlotinib or gefitinib treatment 4)inable of oral drug administration 5)history of myocardial infarction and cerebral infarction within one year 6)planned surgery within study term 7)history of drug allergy 8)massive,pleural effusion or ascites 9)uncontrolled infection or serious medical complications 10)active concomitant malignancy 11)mental disorder 12)pregnant or or lactating women or those who declined contraception 13)those judged not suitable by the attending physician

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Disease Control Rate, Progression-free survival, Overall survival, Surgery rate, Pathological Complete Response Rate, Complete resection rate, Safety, Biomarker	—

Countries

Japan

Contacts

Public ContactToshinari Ema

Itabashi central medical center Department of Thoracic Surgery

toshinariema09@yahoo.co.jp03-3967-0572

Outcome results

None listed

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