A Phase II Study of Carboplatin+weekly Paclitaxel+Bevacizumab in chemo-naive patients with stage IIIB and IV non-squamous, non-small cell lung cancer.

A Phase II Study of Carboplatin+weekly Paclitaxel+Bevacizumab in chemo-naive patients with stage IIIB and IV non-squamous, non-small cell lung cancer. - Phase II study of CBDCA+weekly PTX+Bev in chemo-naive patients with stage IIIB and IV non-sq, non-small cell lung cancer.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003674

Enrollment

Registered

2010-05-30

Start date

2010-06-01

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-squamous, non-small cell lung cancer

Interventions

Patients receive CBDCA(AUC 6,div), Bevacizumab (15mg/kg,div) on day 1 and paclitaxel (70mg/m2,div) on day 1,8,15 every 4 weeks,threee to six cycles. Patients who achieve disease control (response or s

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)histologically or cytologically comfirmed non-squamous*, non-small cell lung cancer *Cases with histological diagnosis of non-small cell lung cancer only, and/or cases with non-small cell lung cancer with less than 50% of squamous components will be applicable. 2)Stage IIIB/IV(UICC-7)or postoperative recurrence NSCLC 3)chemo-naive patients *post-operative therapy with oral UFT is applicable. 4)patients aged 20 years or older 5)ECOG performance status of 0 or 1 6)Measurable by RECIST(ver 1.1)criteria. 7)Patients who has the following periods: palliative radiotherapy(thorax excluded), 2 weeks; operation, 4 weeks; chest drainage, 2 weeks; biopsy with incision, port custody,and treatment to injury, 2weeks; aspiration biopsy cytology, 1 week 8)adequate bone marrow,liver,and renal functions: neutorophil >=1,500/mm3; platelet >=100,000/mm3; Hb >=9.0 g/dl; AST and ALT <2.5x of upper limit of normal (ULN); total bilirubin <=1.5x of upper limit of normal(ULN); serum creatinin <=1.2 mg/dl; SpO2>90; PT-INT <1.5; urinari protein <=1+or 2g/24h 9)a life expectancy of 3 months or more 10)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Uncontrolled infection or serious medical complications 2)massive,pleural effusion or ascites(accept controrable pleural effusion with OK-432) 3)current nervous symptom 4)severe cardiac disease 5)current or previous histoty of hemoptysis(2.5ml)due to NSCLC 6)history of hemoptysis(over 1week) or receive oral/i.v. hemostatic drug 7)uncontrolled hypertension 8)Patients with active lung disease such as interstitial pneumonia,radiation pneumonitis,plumonary infection,or drug-induced lung damage 9)current or previous (within the last 1 year)history of GI perforation 10)history of myocardial infarction and cerebral infarction 11)history of drug allergy 12)active concomitant malignancy 13)pregnant or lactating women or those who declined contraception 14)those judged to be not suitable by the attending physician

Design outcomes

Primary

Measure	Time frame
response rate	—

Secondary

Measure	Time frame
progression free survival, overall survival, time to progression, safety	—

Countries

Japan

Contacts

Public ContactTetsuya Kubota

Kochi University, School of Medicine Dept of Hematology and Respiratory Medicine

kubotat@kochi-u.ac.jp088-880-2345

Outcome results

None listed

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