Non-small cell lung carcinoma
Conditions
Interventions
Docetaxel plus Ramucirumab
Sponsors
Kyoto prefectural University of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who are histology or cytology confirmed as advanced non-small cell lung cancer. 2. Patients have asymptomatic brain metastasis, at least one measurable lesion in the brain (defined as lesion more than 5mm and a double or more of a slice thickness in longest dimension) confirmed by brain MRI. Stereotactic radiosurgery (SRS) (including Gamma Knife or Cyber Knife) before enrollment is allowed. At least 2 weeks has elapsed from the completion of SRS. 3. Patients who have disease progression during or after first-line chemotherapy (including platinum-based agents, non-platinum-based agents, EGFR-TKI, ALK inhibitor or immune checkpoint inhibitor) with or without maintenance therapy. - Patients with progressed disease during or after completion of prior therapy for advanced/metastatic disease. - Prior bevacizumab as first-line and/or maintenance therapy is allowed. 4. Performance Status (ECOG) is 0 or 1 at the time of acquisition of consent. 5. Patients at least 20 years of age (age at the time of acquisition of consent). 6. Patients who have adequate bone marrow, hepatic, and renal functions have all been confirmed as normal within 14 days prior to enrollment. 7. Patients with life expectancy of at least 3 months.
Exclusion criteria
Exclusion criteria: 1. Patients who have never been received anticancer agents. 2. Patients who are currently receiving other anticancer therapy. 3. Patients who have symptomatic brain metastasis or patients who have undergone whole brain radiotherapy or surgical resection for brain metastasis. 4. Patients who have meningeal metastasis. 5. Patients who have either bleeding into the brain metastasis or other CNS hemorrhage on imaging performed within 21days before acquisition of consent. 6. Patients who have radiographic evidence of intratumor cavitation or major blood vessels invasion or encasement by cancer. 7. Patients who have experienced uncontrolled coagulation disorder (acquired or hereditary). 8. Patients who have experienced arterial thromboembolic events, deep vein thrombosis, serious bleeding complications or GI perforation/fistula within 6 months prior to acquisition of consent. 9. Patients who have cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis with history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. 10. Patients who have a serious or non-healing wound, ulcer, or bone fracture within 28 days prior to acquisition of consent. 11. Patients who have uncontrolled or poorly-controlled hypertension, metabolic disorder or clinically serious infection. 12. Patients who are pregnant, nursing or possibly pregnant. 13. The patient is receiving chronic antiplatelet therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| intracranial progression free survival overall survival disease control rate overall response rate safety | — |
Countries
Japan
Contacts
Public ContactKeiko Tanimura
Kyoto prefectural University of Medicine Department of Respiratory Medicine
Outcome results
None listed