Phase II study of erlotinib in advanced or recurrent EGFR mutation positive Non-small cell lung cancer patients who were previously treated with intrapleural therapy for malignant pleural effusion.

Phase II study of erlotinib in advanced or recurrent EGFR mutation positive Non-small cell lung cancer patients who were previously treated with intrapleural therapy for malignant pleural effusion. - Phase II study of erlotinib in advanced or recurrent EGFR mutation positive NSCLC patients who were previously treated with intrapleural therapy for malignant pleural effusion.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006518

Enrollment

Registered

2011-10-12

Start date

2011-02-01

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

Erlotinib

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1,Cytologically or histologically proven non-small cell lung cancer 2)Cytologically or histologically proven malignant pleural effusion associated with non-small cell lung cancer 3,Clinical stage IV or post-operative recurrence 4,Prior tube thoracostomy followed by intrapleural therapy for malignant pleural effusion 5,EGFR mutation positive 6,No prior EGFR tyrosine kinase inhibitor treatment 7,ECOG Performance status 0-3 after tube thoracostomy 8,Adequate organ functions 9,Mesurable lesions (RECIST) 10,Adequate interval after prior treatments; 2 weeks from OK-432, Talc, 6 weeks from Mitomycin 11,Written informed consent

Exclusion criteria

Exclusion criteria: 1,Massive pericardial effusion or ascites 2,Severe drug allergy 3,Active infection 4,Continuous watery diarrhea 5,Intestinal paralysis or ileus 6,Interstitial pneumonia or lung fibrosis evident on CT 7,Symptomatic ophthalmologic disease 8,Current or previous (within the last 1 year) history of GI perforation 9,Serious non&#8212;healing ulcer 10,Symptomatic or steroid-requiring brain metastases 11,Active concomitant malignancy 12,Previous (within the last 5 years) concomitant malignancy 13,Uncontrolled diabetes 14,Severe cardiac disease 15,Severe psychological disease 16,Pregnant or lactating women or those who declined contraception 17,Those judged to be 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, Adverse events, 4-weeks pleural effusion progression free survival rate, Pleural effusion progression free suvival	—

Countries

Japan

Contacts

Public ContactMichiko Yamamoto

Kitasato university hospital Department of respiratory medicine

Outcome results

None listed

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