To evaluate the efficacy and safety of Erlotinib and Bevacizumab in patients with advanced Non-squamous Non-Small Cell Lung Cancer with brain metastasis who acquired resistance to prior EGFR-TKI treatment harboring EGFR mutation.

To evaluate the efficacy and safety of Erlotinib and Bevacizumab in patients with advanced Non-squamous Non-Small Cell Lung Cancer with brain metastasis who acquired resistance to prior EGFR-TKI treatment harboring EGFR mutation. - To evaluate the efficacy and safety of Erlotinib and Bevacizumab in patients with advanced Non-squamous Non-Small Cell Lung Cancer with brain metastasis who acquired resistance to prior EGFR-TKI treatment harboring EGFR mutation.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012515

Enrollment

Registered

2013-12-09

Start date

2013-12-01

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: first enrollment 1)Histologically or cytologically confirmed non-squamous NSCLC 2)StageIIIB/IV or postoperative recurrence NSCLC 3)EGFR mutation(exon18,19,21) positive 4)EGFR-TKI treatment or plan treatment 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 months 7)ECOG PS 0-2 8)Written informed consent from the patients. second enrollment 1)metastasis to brain during EGFR-TKI treatment 2)best effect that was higher than SD was accepted in EGFR-TKI monotherapy 3)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%

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
time to treatment failure after secondary enrollment	—

Secondary

Measure	Time frame
Toxicity 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