Phase II study of continuation maintenance by use of TS1 and Bevacizumab after induction chemotherapy of cisplatin and TS1 pulse bevacizumab in patients with Stage IIIB / IV non-squamous and non-small cell lung cancer - Research of efficacy predictive biomarker

Phase 2

• Conditions: on-small and non-squamous cell lung cancer

• Registration Number: JPRN-UMIN000009871
• Lead Sponsor: Department of Respiratory Medicine National Center for Global health and Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-31
• Study Completion: 2018-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Not provided

Exclusion Criteria

1)Patients with squamous cell lung cancer. 2)History of allergic reaction for agents of present treatment 3)Severe myelosupperssion, renal dysfunction or hepatic dysfunction 4)Patients received post-operation adjuvant therapy within 6 months. 5)Active concomitant malignancy except carcinoma in situ, intramucosal carcinoma or cancer with more than 5 year disease free 6)Significant comorbid disease such as paresis of intestine, ileus, interstitial pneumonia, lung fibrosis, uncontrolled diabetes mellitus, cardiac failure, renal failure, hepatic failure, active gastrointestinal ulcer, myocardial infarction and angina pectoris within 6 months, other uncontrolled disease 7)Diarrhea more than and equal to grade 2 8)Active infection more than and equal to grade 2 9)Massive pleural effusion, peritoneal effusion or cardiac effusion required for tube drainage 10)Symptomatic brain metastasis but eligible for controlled brain metastases 11)Patients required for continuing steroid therapy 12)A history of significant hemoptysis (> 2.5 mL red blood per episode) within 3 months before enrolment 13)History of thrombosis 14)Surgical biopsy or treatment within 4 weeks 15)Under treatment of oral coagulant or intravenous coagulant 16)Bleeding tendency, blood coagulation disorder 17)Other ineligible for bevacizumab 18)Pregnant status or lactation 19)Uncontrolled psychiatric disease 20)Other ineligible status judged by medical oncologist.

Study & Design

• Study Type: Interventional
• Study Design: Not specified