A phase II study of Conbination therapy of Cisplatin/Pemetrexed/Bavacizumab in previously untreated patients with StageIIIB/IV or recurrent disease nonsquamous non-small cell lung cancer

Phase 2

Recruiting

• Conditions: non-small cell lung cancer

• Registration Number: JPRN-UMIN000006874
• Lead Sponsor: Fukushima medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-12-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

Not provided

Exclusion Criteria

1)Patients with untreated Brain metastases 2)Patients with current or previous history of hemoptysis (2.5mL or more) 3)Patients with uncontrolled hyper tension 4)Patients with uncontrolled infection 5)Patients with active lung disease such as interstitial pneumonia, pneumoconiosis, active radiation pneumonitis, pulmonary fibrosis or drug-induced pneumonitis 6)Patients with uncontrollable complications 7)Patients with massive pleural or pericardial effusion,or ascites 8)Patients with active concomitant malignancy 9)Patients with previous histories of drug allergy 10)Patients with uncontrollable gastrointestinal ulceration 11)Patients with current or previous (within one year) history of gastrointestinal perforation 12)Patients with therapeutic anticoagulopathy (including Aspirin over 325mg/day) 13)Pregnancy or lactation 14)Inappropriate patients for this study judged by the physicians

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Two years overall survival rate

Secondary Outcome Measures

Name	Time	Method
Progression-free survival, Overall survival, Time to Treatment Failure, Response rate, Disease control rate, Adverse events, Response rate of each EGFR status, Biomarkers