Phase II study of efficacy of Bevacizumab plus chemotherapy for malignant pleural effusion (MPE) management of treated or untreated non-squamous non-small lung cancer(NSCLC) patients with uncontrollable MPEs by pleurodesis (NEJ-013B-2)

Phase II study of efficacy of Bevacizumab plus chemotherapy for malignant pleural effusion (MPE) management of treated or untreated non-squamous non-small lung cancer(NSCLC) patients with uncontrollable MPEs by pleurodesis (NEJ-013B-2) - Efficacy of Bevacizumab plus chemotherapy for advanced NSCLC with uncontrollable MPE: Phase II study (NEJ-013B-2)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006868

Enrollment

Registered

2011-12-10

Start date

2012-01-01

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

Interventions

Two or more cycles of Bevacizumab plus any chemotherapy except tageted therapies

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.historogically or cytologically comfirmed non-squamous NSCLC 2.MPEs cytologically proven (class IV or V) of stage4 or post-operative recurrent patients. 3.unsuitable or unsuccessful patients with non-squamous NSCLC and MPEs for tube drainage or pleurodesis (OK-432, minocycline, etc, except cytotoxic agent). 4. ECOG PS 0-2 5. 20 years old or older 6. adequate organ function 7. Following interval between the below therapie ansd registration; palliative radiotherapy-2weeks or more surgery-4weeks or more open biopsy, treatment of injury and chest tube drainage-1week or more blood transfusion-2weeks or more 8. life expectancy more than 3 months 9. written informed consent

Exclusion criteria

Exclusion criteria: 1.interstitial pneumonia or pulmonary fibrosis detectable on CT scan 2. history of gross hemoptpsis (2.5ml or more) or severe hemosputum (over 1 week, or reciveing hemostatic drug) 3. symptomatic brain metastasis 4.recieving anticoagulant drug (except Aspirin under 324mg/day) 5. scheduled operation 6. invasion to major vessels 7. pulmonary tumor with the cavity 8. severe complication 9. uncontrolled infection 10. Uncontrollable gastriointestinal ulceration 11. history of GI perforation or ulceration (within 1 year) 12.present pregnant or lactation 13. severe drug allegy 14. history of myocardial infarction or cerebral infarction (within 1 year) 15.active concomitant malignancy 16. inappropriate patients judged by the phsicians

Design outcomes

Primary

Measure	Time frame
Pleural effusion control rate (PECR), defined as the percentage of patients without reaccumulation of MPE for eight weeksfor eight weeks from the start of treatment	—

Secondary

Measure	Time frame
Pleural Progression free survival(PPFS) defined as progression-free survival time (PFS) without reaccumulation of MPE, calculated from the time of starting bevacizumab-based therapy until the day on which pleural effusions increased again, or the day of death regardless of cause; Safty; QOL; Biomarker analysis	—

Countries

Japan

Contacts

Public ContactAkihiko Miyanaga

Nippon Medical School Department of Pulmonary Medicine and Oncology, Graduate School of Medicine

a-miyanaga@nms.ac.jp03-3822-2131(6651)

Outcome results

None listed

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