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A pilot study of Pemetrexed, Platinum agent plus Bevacizumab for advanced non-squamous non-small cell lung cancer with brain metastases

A pilot study of Pemetrexed, Platinum agent plus Bevacizumab for advanced non-squamous non-small cell lung cancer with brain metastases - A pilot study of Pemetrexed, Platinum agent plus Bevacizumab for advanced non-squamous non-small cell lung cancer with brain metastases

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000011615
Enrollment
10
Registered
2013-08-31
Start date
2013-09-01
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

Advanced non-squamous NSCLC

Interventions

Cisplatin or CBDCA + pem+bev followed by pem+bev until PD

Sponsors

Yokohama Rosai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. aged 20 years or over 2. stageIV or recurrence of post operative patient 3. pathologically confirmed non- squamous NSCLC 4. Patients with life expectancy for more than 3 months 5. Performance Status 0-1 6. treated with radiotherapy or surgery to brain metastases 7. untreated patients without EGFR-TKI 8. measurable or nonmeasurable disease 9. Patients with adequate organ function as following Neutrophil count >= 1500/mm3 Platelet count >= 100,000/mm3 Hemoglobin >= 9.0 g/dL Aspartate aminotransferase and alanine aminotransferase < 2.5 times the upper limit of normal Total bilirubin <= 1.5mg/dL Serum creatinine <= 1.5mg/dL PT-INR<1.5 Ccr>=60mL/min(CDDP), 45mL/min(CBDCA) Urine protein<=+1 10. No Exploratory thoracotomy within 4 weeks No pleural drainage within 2 weeks 11. Written informed consent can be obtained.

Exclusion criteria

Exclusion criteria: 1. symptomatic brain metastasis 2. history or complication of hemoptysis. 3. history of severe drug allergy 4. uncontrolled ascites, pleural effusion, or pericardial effusion 5. history of gastrointestinal perforation within one year, or a complication 6. uncontrolled hypertension 7. active infection requiring systemic administration of antiviral agents, antifungal agents, or antibiotics 8. antipletet therapy for chronic disease 9. irradiation to the chest or more than 20% region of bones 10. multiple cancer within 5 years 11. serious complications 12. pregnancy or lactation 13. inappropriate for this study judged by the attending physician

Design outcomes

Secondary

MeasureTime frame
any CNS adverse effects

Primary

MeasureTime frame
Response rate

Countries

Japan

Contacts

Public ContactTakashi Uehara

Yokohama Rosai Hospital Department of Pulmonary Medicine

takashiu@yokohamah.rofuku.go.jp045-474-8111

Outcome results

None listed

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