RET fusions are present in 1% to 2% of unselected population of non-small cell lung cancer (NSCLC). Existing US Food and Drug Administration-approved inhibitors of RET tyrosine kinase show promising therapeutic effects in a non-small cell lung cancer patients. Apatinib is an oral multi-kinase inhibitors including RET fusions. This study is designed to evaluate the safety and tolerability of Apatinib in patients with RET fusion positive advanced NSCLC.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
For RET-fusion positive advanced NSCLC patients who failed to previous treatment,treat with apatinib, single agent, 750mg once daily, p.o until disease progression
Department of Oncology, Shanghai pulmonary hospital
Shanghai, China
RECRUITINGObjective Response Rate (ORR)
To evaluate ORR every 6-8 weeks after initiation of apatinib
Time frame: change from baseline in tumor size every 6-8 weeks after the initiation of apatinib, up to 24 months
Progression Free Survival (PFS)
PFS is evaluated in 24 months since the treatment began
Time frame: 24 months
overall survival (OS)
evaluated in the 24th month since the treatment began
Time frame: 24 months
Safety and Tolerability as measured by adverse events
Number of Participants with treatment related Adverse Events as Assessed by CTCAE v4.0
Time frame: 24 months
quality of life (QOL, measured by questionnaire)
Change from baseline in Pain on the 11 point short pain scale (SPS-11)
Time frame: 24 months
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