Phase II study of erlotinib in previously treated non-small cell lung cancer (NSCLC) with wild type EGFR(NEJ006/TCOG0903)

Phase II study of erlotinib in previously treated non-small cell lung cancer (NSCLC) with wild type EGFR(NEJ006/TCOG0903) - Erlotonib in pre-treated NSCLC with wild type EGFR

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002795

Enrollment

Registered

2009-11-25

Start date

2009-11-01

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

Pre-treated non-small cell lung cancer with wild type EGFR and occurred in never or light smoker

Interventions

Daily administration of erlotinib

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Histologically or cytologically proved NSCLC 2)Stage IIIB, IV disease, or relapsed diseases after surgery that lack indication of surgery or radiotherapy 3)A tumor specimen is available 4)Wild type EGFR 5)Measureable region evaluable according to the RECIST 6)Number of previous chemotherapy regimens are 1 or 2 7)No previous EGFR-TKI treatment 8)Never or light smoker less than 10 pack year 9)Elder than 20 years of age 10)ECOG performance status of 0-2 11)Expected to be observed for at least 2 weeks in a hospital or in a comparable institution after the initiation of erlotinib treatment 12)Adequate organ functions (WBC => 3,000 /mm3, Neutrophil =>1,000 /mm3, Platelet => 100,000 /mm3, hemoglobin concentration => 9.0 g/dl, AST or ALT <= ULN x 2, Total bilirubin <= 1.5 mg/dl, Cr <= 1.5 mg/dl, SpO2 => 95%) 13)Life expectancy of at least 3 months 14)Sufficient time has elapsed after the previous treatment (1)More than 3 weeks after last day of chemotherapy (2)More than 12 weeks after thoracic radiation (3)More than 2 weeks after surgical treatment 15)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Presence of active interstitial pneumonia, radiation pneumonia, pneumoconiosis, or drug induced pneumonia 2)Uncontrolled pleural effusion, ascites, or pericardial effusion 3)Presence of infection that necessitates treatments with intravenous antibiotics 4)History of HER-related drug treatment 5)T790M mutation 6)Symptomatic eye disease 7)Pregnant patients 8)Symptomatic brain metastases 9)Other active malignancies 10)Poorly controlled diabetes mellitus 11)Severe and uncontrolled complication 12)Current smoker 13)Evaluated to be ineligible by a physician for other reasons

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Disease control rate, progression free survival, overall survival, and safety. The biomarkers that predict the efficacy will be searched.	—

Countries

Japan

Contacts

Public ContactYasuo Saijo

Hirosaki University Graduate School of Medicine Department of Medical Oncology

yasosj@cc.hirosaki-u.ac.jp81-172-39-5345

Outcome results

None listed

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