A Phase II Study of Vandetanib in Patients With Non-small Cell Lung Cancer Harboring RET Rearrangement
Patients will be screened so as to confirm RET fusion in their tumor tissue. RET fusion will
be tested using fluorescence in situ hybridization (FISH) at central laboratory. Central
laboratory of this study is the department of pathology at Seoul National University
Hospital (SNUH) and tumor specimen should be sent to department of pathology at SNUH. Only
patients whose tumor have confirmed RET gene fusion are eligible for this study.
Enrolled patients will begin on once daily vandetanib at 300 mg with one cycle of 4 weeks.
Renal-impaired patients (defined as patients with creatinine clearance ≥30 to <50 mL/min at
screening) will start treatment at the lower dose of 200 mg. Treatment will be continued
till progression, unacceptable toxicity, or till 1 year. Vandetanib can be administered
after 1 year to the patients with benefit from vandetanib.
During the administration of vandetanib, vital signs, physical examination, ECOG performance
status, height, weight, hematology and chemistry test, ECG, adverse events and concomitant
drugs will be evaluated every four weeks (one cycle, for the first 6 months) or eight weeks
(two cycles, from 6 months to 1 year) and, if necessary, chest X-ray and pregnancy test will
also be performed. CT for tumor assessment will be performed once every 8 weeks for 1 year.
If the disease progression is suspected, the test can be additionally conducted at the
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate (ORR)
ORR will be evaluated through the frequency analysis with 95% confidence interval.
Korea: Food and Drug Administration