A Study of Apatinib Plus Docetaxel for Treatment of Advanced Non-squamous Non-small Cell Lung Cancer With Bone Metastases

Sponsor
Affiliated Hospital of Hebei University
Study ID
NCT03127319
Phase
PHASE2
Status
Unknown

Conditions

  • Non-squamous Non-small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • apatinib docetaxel zoledronic — DRUG
    apatinib 500 mg qd p.o.docetaxel 60mg/m² iv q3w;zoledronic 4mg iv\>15min q4w until disease progression or intolerable toxicity or patients withdrawal of consent
  • docetaxel zoledronic — DRUG
    docetaxel 60mg/m² iv q3w;zoledronic 4mg iv\>15min q4w until disease progression or intolerable toxicity or patients withdrawal of consent

Study Details

The purpose of this study is to assess the efficacy and safety of patients who receive apatinib plus docetaxel and zoledronic versus docetaxel and zoledronic alone as second line treatment for advanced non-squamous non-small cell lung cancer with bone metastases.

Key Dates

Start date
Jul 3, 2017
Status verified
Jan 2017
Primary completion
Apr 30, 2019
Completion
Dec 31, 2019

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: apatinib and docetaxel zoledronic
    apatinib 500mg qd po; docetaxel 60mg/m² iv q3w; zoledronic 4mg iv\>15min q4w until disease progression or intolerable toxicity or patients withdrawal of consent
  • Active Comparator: docetaxel zoledronic
    docetaxel 60mg/m² iv q3w;zoledronic 4mg iv\>15min q4w until disease progression or intolerable toxicity or patients withdrawal of consent

Primary Outcome Measure

Progression free survival [ Time Frame: evaluation per 2 cycles (6 weeks) ]

Central Contacts

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