A phase II study of Bevacizumab combined with Carboplatin and Weekly Paclitaxel for Patients with Advanced Non-Squamous Non-Small-Cell Lung Cancer. North Japan Lung Cancer Study Group Trial 1002

A phase II study of Bevacizumab combined with Carboplatin and Weekly Paclitaxel for Patients with Advanced Non-Squamous Non-Small-Cell Lung Cancer. North Japan Lung Cancer Study Group Trial 1002 - CBDCA+wPTX+BEV Phase II NJLCG1002

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003949

Enrollment

Registered

2010-07-31

Start date

2010-08-01

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) on day1, Bevacizumab (15mg/kg, div) on day1 and Paclitaxel (70mg/m2, div) on days 1, 8, 15 every 4 weeks, up to 6 cycles. Patients who achieve disease control (re

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically confirmed non-squamous, non-small cell lung cancer (Non-Squamous NSCLC). 2) Stage III/IV unresectable or unsuitable for radical irradiation or postoperative recurrent Non-Squamous NSCLC. 3) Chemotherapy naive and thoracic irradiation naive patients. *UFT adjuvant therapy is acceptable. *OK-432 therapy is acceptable for pleuridesis procedure. *Extrathoracic irradiation is acceptable, if it was completed more than two weeks before enrollment. 4) ECOG-PS of 0 or 1. 5) Age: 20-74 years old. 6) Measurable by RECIST ver.1.1 criteria. 7) Adequate organ function. WBC >= 4,000/mm3 (Or Neutrophil >= 2,000/mm3) Hb >= 9.0g/dl Platelet >= 100,000/mm3 T-Bil <= 1.5g/dl GOT (AST), GPT (ALT) < 100 IU/l Serum Cr <= 1.5mg/dl Ccr >= 40 ml/min (calculated by Cockcroft-Gault formula) 8) Life expectancy more than 3 months. 9) Written informed consent.

Exclusion criteria

Exclusion criteria: 1) Clinically active interstitial pneumonia or pulmonary fibrosis, detectable on CT scan. 2) Uncontrollable pleural or pericardial effusion or ascites. 3) Current or previous hemoptysis (>=1 teaspoon). 4) Brain metastasis. 5) Tumor invading thoracic major vessel. 6) Tumor with cavity. 7) Severe co-morbidities (ex. uncontrolled heart or lung or hepatic or renal disease or diabetes). 8) Regular use of corticosteroid (less than 2 weeks interval after cessation). 9) Active gastrointestinal ulcer. 10) Peripheral sensory neuropathy >= Grade 2. 11) Pregnancy or lactation, or those who decline contraception. 12) Hypersensitivity of Taxans or alcohol and the medicine made of the polio castor oil content. 13) Active concomitant malignancy. Except carcinoma in situ or those who did not relapse 5-years or more. 14) Contraindication with carboplatin or paclitaxel or bevacizumab. 15) Those judged to be not suitable by the attending physician.

Design outcomes

Primary

Measure	Time frame
response rate, adverse events	—

Secondary

Measure	Time frame
progression free survival, overall survival	—

Countries

Japan

Contacts

Public ContactMakoto Maemondo

Miyagi Cancer Center Dept. of Respiratory Medicine

022-384-3151

Outcome results

None listed

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