Study of Apatinib in RET Fusion Positive Advanced Non-small Cell Lung Cancer

Sponsor
Tongji University
Study ID
NCT02540824
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Apatinib single agent arm — DRUG
    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

Study Details

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.

Key Dates

Start date
Jan 31, 2015
Status verified
Sep 2015
Primary completion
Dec 31, 2016
Completion
Dec 31, 2017

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Apatinib single agent arm
    Apatinib, single agent, 750mg once daily p.o until disease progression

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: change from baseline in tumor size every 6-8 weeks after the initiation of apatinib, up to 24 months ]

Central Contacts

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