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Phase II study of cisplatin plus S-1 with bevacizumab as first-line therapy for stage III/IV nonsquamous non-small-cell lung cancer

Phase II study of cisplatin plus S-1 with bevacizumab as first-line therapy for stage III/IV nonsquamous non-small-cell lung cancer - Phase II study of CDDP+S-1+Bevacizumab for advanced nonsquamous non-small-cell lung cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003487
Enrollment
24
Registered
2010-04-16
Start date
2010-04-01
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 (nonsquamous cell lung cancer)

Interventions

Cisplatin (60mg/m2) and bevacizumab (15mg/kg) is administered on day 1, and S-1 (80mg/m2/day) is administered from day 1 to day 14

Sponsors

Gunma University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Histologically and/or cytologically proven nonsquamous NSCLC; patients with unresectable stage IIIB or IV, no previous chemotherapy or radiotherapy; a performance status of 0-1 on the Eastern Cooperative Oncology Group; adequate bone marrow reserve (leukocyte ≥4000/mm3,neutrophil≥2000/mm3, platelet ≥100,000/mm3,hemoglobin≥9g/dL; normal liver function (total serum bilirubin≤1.5mg/dL, and aspartate transaminase (AST), alanine transaminase (ALT) less than twice the upper limit of the normal range) and normal renal function (creatinine clearance≥60mL/min);PaO2≥60 torr or SpO2≥90%; proteinuria≤+1, INR≤1.5; a life expectancy of 12 weeks or more;written informed consent should be obtained from all patients.

Exclusion criteria

Exclusion criteria: squamous cell (adenosquamous cell) lung cancer; Patients with a history of serious drug allergy, hemoptysis, thrombosis, concomitant malignancy, central nervous system metastases, active infectious diseases or other serious medical problems;hemorrhagic diathesis or coagulopathy; therapeutic anticoagulation; regular use of aspirin (>325 mg per day), nonsteroidal antiinflammatory agents, or other agents known to inhibit platelet function;use of steroid or flucytosine;pregnancy ;

Design outcomes

Primary

MeasureTime frame
response rate

Secondary

MeasureTime frame
overall survival, progression-free survival, time to treatment failure, safety

Countries

Japan

Contacts

Public ContactNoriaki Sunaga

Gunma University Hospital Department of Respiratory Medicine

027-220-8123

Outcome results

None listed

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