ALK-positive non-small cell lung cancer
Conditions
Interventions
Alectinib Bevacizumab
Sponsors
Niigata Lung Cancer Treatment Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Non-small cell lung cancer proven by histology and/or cytology 2) ALK-rearrangement confirmed by FISH, IHC or RT-PCR 3) Patients who had responded to alectinib and showed disease progression 4) 20 years or older 5)At least one or more measurable lesion by RECIST ver1.1 6) Performance status (ECOG) 0 to 1 7) Adequate organ function 8)Life expectancy more than twelve weeks 9)Written informed consent
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival, Overall Response Rate, Disease Control Rate | — |
Countries
Japan
Contacts
Public ContactSatoshi Watanabe
Niigata University Medical & Dental Hospital Department of Respiratory and Infectious Diseases
Outcome results
None listed