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AnRandomized Phase II Trial comparing CDDP plus S-1 with Bevacizumab and CDDP plus Pemetrexed with Bevacizumab against patients with Advanced Non-Squamous Non-Small Cell Lung Cancer

AnRandomized Phase II Trial comparing CDDP plus S-1 with Bevacizumab and CDDP plus Pemetrexed with Bevacizumab against patients with Advanced Non-Squamous Non-Small Cell Lung Cancer - Randomized phase 2 of CDDP and PEM or S-1 plus Bev

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000035401
Enrollment
50
Registered
2018-12-29
Start date
2017-08-30
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 non-small cell lung cancer

Interventions

Cisplatin+S-1+Bev Cisplatin+PEM+Bev

Sponsors

Gunma Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Eligible patients were required to have: histologically and/or cytologically proven unresectable stage IIIB or IV non-squamous NSCLC; no previous chemotherapy or radiotherapy; a performance status (PS) of 0-1 on the Eastern Cooperative Oncology Group; an age between 20 years and 74 years; a life expectancy of 12 weeks or more; adequate bone marrow reserve (leukocyte count > 4000 mm-3, neutrophil count > 2000 mm-3, platelet count > 100000 mm-3, and hemoglobin > 10 g dL-1); normal liver function (total serum bilirubin < 1.5 mg dL-1, and aspartate transaminase (AST), alanine transaminase (ALT) less than twice the upper limit of the normal range), normal renal function (normal serum creatinine and blood urea nitrogen levels) and pulmonary function (PaO2 > 70 torr). Signed informed consent

Exclusion criteria

Exclusion criteria: Patients were excluded if they had malignant pleural or pericardial effusion, active double cancer, a concomitant serious illness, such as uncontrolled angina pectoris, myocardial infarction in the previous 3 months, heart failure, uncontrolled diabetes mellitus, uncontrolled hypertension, interstitial pneumonia or lung disease, infection or other diseases contraindicating chemotherapy or radiotherapy, pregnancy, or breast-feeding. Judging of inappropriate condition for this study by physian

Design outcomes

Primary

MeasureTime frame
progression-free survival

Secondary

MeasureTime frame
overall survival, overal response rate, time to treatment failure, safety

Countries

Japan

Contacts

Public ContactKyoichi Kaira

Gunma University Hospital Department of Respiratory Medicine

kkaira1970@yahoo.co.jp027-220-7111

Outcome results

None listed

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