To observe objective response rate (ORR) of apatinib in RET fusion positive pre-treated advanced NSCLC.
To observe Progression free survival （PFS）. To assess the overall survival (OS). To assess safety and tolerability. To evaluate quality of life. To explore the relationship between biomarkers and the toxicity/efficacy of apatinib.
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Aged ≥18 and ≤80 years.
ECOG performance status of 0 to 1.
Life expectancy of more than 12 weeks.
At least one measurable lesion exists.(RECIST 1.1)
Histologically or cytologic confirmed RET fusion positive advanced Non-small cell lung cancer who failed to prior therapies.
Required laboratory values including following parameters: ANC: ≥ 1.5 x 10\^9/L, Platelet count: ≥ 80 x 10\^9/L, Hemoglobin: ≥ 90 g/L, Total bilirubin: ≤ 1.5 x upper limit of normal, ULN, ALT and AST: ≤ 1.5 x ULN, BUN and creatine clearance rate: ≥ 50 mL/min LVEF: ≥ 50% QTcF: \< 470 ms
Signed informed consent
Females of child-bearing potential must have negative serum pregnancy test. Sexually active male and those having childbearing potential must practice contraception during the study.
You may not be if
Squamous carcinoma (including adeno-squamous carcinoma), small cell lung cancer
Subjects with third space fluid that can not be controled by drainage or other methods.
Obvious cavity or necrosis formed in the tumor
Uncontrolled hypertension
Hymoptysis, more than 2.5ml daily
Thrombosis in 12 months, including pulmonary thrombosis, stroke, or deep venous thrombosis
Received big surgery, had bone fracture or ulcer in 4 weeks
Urine protein \>++, or urine protein in 24 hours\> 1.0g
pregnant or lactating woman
Receiving any other antitumor therapy.
Known history of hypersensitivity to apatinib or any of it components.
Clareo Health | Study of Apatinib in RET Fusion Positive Advanced Non-small Cell Lung Cancer
