To assess the efficacy and toxicity of Osimertinib plus ramucirumab
Conditions
Interventions
Sponsors
Wakayama Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pathologically confirmed, lung adenocarcinoma, with clinical stage IIIB, IV, or recurrence after curative surgery, or radiotherapy. 2) With EGFR sensitive mutation (exon 19 deletion, or exon 21 L858R) 3) Radiological progression was confirmed after the first or second generation EGFR-TKIs (gefitinib, erlotinib, afatinib, or dacomitinib), and EGFR T790M mutation was detected. 4) Aged more than 20 years at the time of study entry 5)ECOG performance status (PS) of 0-1 6) With measurable lesion 7) Adequate organ function
Exclusion criteria
Exclusion criteria: 1) Any history of interstitial pneumonia, or any evidence of interstitial lung disease by CT scan. 2) Not able to swallow tablets. 3) Considered to be high risk of bleeding. 4) The patient has a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism during the 3 months prior to first dose of protocol therapy 5) With serious illness or medical condition6) Undergone prior therapy, or procedure within defined period prior to enrollment 7) With local infection that requires procedure, or active systemic infection 8) HBS antigen (+) 9) Leptomeningeal carcinomatosis 10) Concurrent malignancy 11) Pregnant (must be negative serum pregnancy test or repeated urine test within 7 days prior to first dose), breast feeding, childbearing potential at enrollment, or not willing to use adequate contraceptive methods 12) Serious psychiatric condition that is hard to register this study 13) Known history of serious allergy 14) Other reason that the investigator would make the patient ineligible for entry into this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxicity (DLT) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR) Progression-free survival (PFS) Overall survival (OS) Time to treatment failure (TTF) Safety | — |
Countries
Japan
Contacts
Public ContactYuichi Ozawa
Wakayama Medical University Respiratory Medicine and Clinical Oncology
Outcome results
None listed