Phase II study of OK-432 intrapleural administration followed by systemic carboplatin, pemetrexed and bevasizumab for non-squamous non-small cell lung cancer with pleuritis carcinomatosa

Phase II study of OK-432 intrapleural administration followed by systemic carboplatin, pemetrexed and bevasizumab for non-squamous non-small cell lung cancer with pleuritis carcinomatosa - Phase II study of OK-432 intrapleural administration followed by systemic carboplatin, pemetrexed and bevasizumab for non-squamous non-small cell lung cancer with pleuritis carcinomatosa

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004199

Enrollment

Registered

2010-09-14

Start date

2010-09-01

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-squamous non-small cell lung cancer with pleuritis carcinomatosa

Interventions

1.administration of OK432 5-10KE 2.Cb(AUC5)day1+Pem 500mg/m2 day1+Bev 15mg/kg day1:q3-4w

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)histologically or cytologically confirmed non-small non-squamous cell lung cancer 2)untreated or previous 1 or 2 regimens chemotherapy without pemetrexed and bevasizumab or relapse after surgery 3)pleuritis carcinomatosa 4)Age: over 20 years old 5)ECOG Perfomance status 0-2 6)preserved organ's function WBC>=3,000/mm3 Hemoglobin>= 9.0g/dl Platelet count>=100,000/mm3 Total serum bilirubin <=1.5 mg/dl AST/ALT <100 IU/l Serum creatinine <=1.5mg/dl 7)Acquisition of written informed consent

Exclusion criteria

Exclusion criteria: 1)Massive pericardial effusion 2)Severe complications; myocardial infarction, unstable angina, heart failure, uncontrolled hypertension, and unconrolled diabetis mellitus, uncontrolled infection. 3)Severe bone marrow suppression 4)Previous carboplatin allergy 5)Brain metastsis 6)Hemoptysis(more than 2.5ml), continuous or treatment-required bloody sputum 7)Lung fibrosis 8)Pregnancy 9)Other inappropriate cases

Design outcomes

Primary

Measure	Time frame
progression free survival two months after OK-432 intrapleural administration.	—

Secondary

Measure	Time frame
response rate overall survival progression free survival adverse events	—

Countries

Japan

Outcome results

None listed

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