A phase II study of Erlotinib Plus Bevacizumab in patients with advanced Non-squamous Non- Small Cell Lung Cancer with brain metastasis and Harboring Epidermal Growth Factor Receptor Mutations.

A phase II study of Erlotinib Plus Bevacizumab in patients with advanced Non-squamous Non- Small Cell Lung Cancer with brain metastasis and Harboring Epidermal Growth Factor Receptor Mutations. - A phase II study of Erlotinib Plus Bevacizumab in patients with advanced Non-squamous Non- Small Cell Lung Cancer with brain metastasis and Harboring Epidermal Growth Factor Receptor Mutations.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012514

Enrollment

Registered

2013-12-09

Start date

2014-01-01

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-Small-Cell Lung Cancer

Interventions

Erlotinib 150mg/day, oral daily Bevacizumab 15mg/kg, intravenous q3w

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Histologically or cytologically confirmed non-squamous NSCLC 2)brain metastasis 3)StageIVor postoperative recurrence NSCLC 4)EGFR mutation(exon18,19,21) positive 5)Age>=20years 6)Patients without previous treatment for lung cancer A patient who has received postoperative chemotherapy is eligible if the last administration of the prior adjuvant regimen occurred at least 12 month 7)ECOG PS 0-2 8)Adequate function of main organ evaluated within enrollment as WBC=3,000~12000/mm3 Neu>=1,500/mm3 Plt>=10.0x10000/mm3 hemoglobin >=8.5g/dL AST,ALT=<2.5xULN T-bil=<2.0mg/dL Cr>=2.0xULN Proteinuria<1+ SpO2>=90% 9)Written informed consent from the patients.

Exclusion criteria

Exclusion criteria: 1)Squamous cell carcinoma 2)Interstitial pneumonia or pulmonary fibrosis on chest CT scans 3)History of EGFR-TKI, VEGF antibody allergic reaction. 4)Brain metastasis expected bleeding 5)Radiotherapy enforcement example for the brain 6)Active severe comorbidity disease. 7)History of hemoptysis 8)Uncontrollable hypertension 9)History of gastrointenstinal perforation or diverticulitis or fistula 10)Scheduled operation 11)Active concomitant malignancy 12)Pregnant or breast-feeding females 13)Inappropriate patients for this study judged by the physicians

Design outcomes

Primary

Measure	Time frame
time to treatment failure	—

Secondary

Measure	Time frame
Toxicity Response Rate for extracranial metastases Response Rate for intracranial metastases Overall survival	—

Countries

Japan

Contacts

Public ContactSho Saeki

Kumamoto University Hospital Department of Respiratory Medicine

saeshow@wg7.so-net.ne.jp096-373-5012

Outcome results

None listed

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