A phase II study of Docetaxel with Bevacizumab for EGFR mutation negative previously treated non-squamous non-small cell lung cancer

A phase II study of Docetaxel with Bevacizumab for EGFR mutation negative previously treated non-squamous non-small cell lung cancer - A phase II study of Docetaxel with Bevacizumab for EGFR mutation negative previously treated non-squamous non-small cell lung cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006532

Enrollment

Registered

2011-10-14

Start date

2011-06-01

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

Docetaxel with Bevacizumab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically or cytologically confirmed non-squamous non-small cell lung cancer 2. Clinical stage : IIIB/IV 3. 20<= years <70 4. Performance status (ECOG) : 0-2 5. Relapsed or progressed to one or more prior chemotherapy 6. Less than 4 weeks observation since relapse or progression. 7. No prior treatment with Docetaxel. 8. With one or more measurable disease based on RECIST 9. Adequate function of vital organs as following: Neutrophils >= 1,500/mm3 Hemoglobin >= 9.0 g/dL Platelets >= 75,000/mm3 AST and ALT <= 2.5ULN Total bilirubin <= 1.5ULN Serum albumin <= 2.5mg/dL Serum creatinine <= 1.2mg/dL Creatinine Clearance >= 45ml/min Urinary protein <= 1+ 10. No chemotherapy within 21days prior to the study. No thoracic radiotherapy within 28days prior to the study. No radiotherapy (except thoracic) within 7days prior to the study. No G-CSF within 7days prior to study. No pleurodesis, pleural drainage etc. within 14days prior to the study 11. A life expectancy of more than 3 months 12. Written informed consent before initiation of study-related procedures

Exclusion criteria

Exclusion criteria: 1. EGFR mutation status positive 2. CNS metastasis 3. History or complication of hemoptysis with 2.5mL per time or more. Continuouis bloody phlegm more than 1 week. History or complication of bloody phlegm treated with continuous oral hemostatic agent. History or complication of bloody phlegm treated with infusional hemostatic agent. 4. Tendency to hemorrhages 5. continuous medication with anticoagulant drug(including Aspirin over 325mg/day) for Thrombus treatment 6. Invasion to major vessel or cavitations of tumor 7. Planning of concurrent thoracic radiotherapy (excluding if radiation field does not cover the chest 8. Pericardial effusion requiring drainage 9. Superior vena cava syndrome 10. Uncontrollable peptic ulcer 11. History of GI perforation 12. Uncontrollable hypertension 13. Symptomatic congestive heart failure, Unstable angina, arrhythmia requiring treatment 14. Severe myelosuppression 15. Severe infection 16. Severe psychological illness 17. Interstitial pneumonia or pulmonary fibrosis detectable on X ray. 18. With a history of drug sensitivity for Docetaxcel or Bevacizumab. 19. In pregnancy, during breast feeding, or possibility of pregnancy. 20. Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.

Design outcomes

Primary

Measure	Time frame
Progression Free Survival	—

Secondary

Measure	Time frame
Response Rate Disease Control Rate Overall Survival Maximum tumor volume change Safety Profile	—

Countries

Japan

Contacts

Public ContactTetsuo Shimizu

Nihon University School of Medicine Respiratory Medicine

shimizu.tetsuo@nihon-u.ac.jp03-3972-8111

Outcome results

None listed

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