Phase II trial of the addition of bevacizumab to alectinib beyond progressive disease in ALK-positive advanced non-small-cell lung cancer.
- Conditions
- ALK-positive non-small cell lung cancer
- Registration Number
- JPRN-UMIN000017828
- Lead Sponsor
- iigata Lung Cancer Treatment Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 11
Not provided
1)Have hemosputum more than 2.5ml 2)Evidence of bleeding diathesis 3)Evidence of tumor invading a perihilar blood vessel or cavitation in intra-thoracic lesion on imaging 4)Evidence of thombosis on imaging 5)Have had or require continuous administration of warfarin, heparin, or aspirin at the dose of more than 324mg per day. 6)Have uncontrolable hypertension 7)Have interstital pneumonia or idiopathic pulmonary fibrosis on CT 8)Have grade 2 or more non-hematological toxicity by alectinib 9)Have symptomatic brain metastases 10)Radiotherapy for primiary lesion 11)Have any severe disease complications 12)Have severe infection including hepatitis B which requires anti-virus agents. 13)Have a history of active double cancer 14)Have severe digestion and absorption disorder 15)Have severe mental disorder 16)Patients whose participation in the trial is judged to be in appropriate by the doctor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival
- Secondary Outcome Measures
Name Time Method Overall Survival, Overall Response Rate, Disease Control Rate