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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| apatinib and docetaxel zoledronic | Experimental | 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 |
|
| docetaxel zoledronic | Active Comparator | docetaxel 60mg/m² iv q3w;zoledronic 4mg iv>15min q4w until disease progression or intolerable toxicity or patients withdrawal of consent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | evaluation per 2 cycles (6 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | evaluation per 2 cycles (6 weeks) | |
| DCR (Disease control rate) | evaluation per 2 cycles (6 weeks) | |
| ORR (Objective response rate) |
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Inclusion Criteria:
Age:18 to 75 years old (man or female)
Pathologically diagnosed with metastatic or recurrent non-squamous non-small cell lung cancer
Patients with at least one evaluate lesions of the lung and bone metastases.(measuring≥10mm on spiral CT scan, satisfying the criteria in RECIST1.1 and WHO)
Refractory or failure of prior therapy
Life expectancy greater than or equal to 3 months
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Major organ function has to meet the following criteria:
For results of blood routine test (without blood transfusion within 14 days)
For results of blood biochemical test:
Women of childbearing age must have contraceptive measures or have test pregnancy (serum or urine) enroll the study before 7 days, and the results must be negative, and take the methods of contraception during the test and the last to have drugs after 8 weeks. Men must be contraception or has sterilization surgery during the test and the last to have drugs after 8 weeks;
Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aimin Zang | Contact | 13930881628 | 15175292891@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Hebei university | Recruiting | Baoding | Hebei | China |
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| docetaxel zoledronic | Drug | docetaxel 60mg/m² iv q3w;zoledronic 4mg iv>15min q4w until disease progression or intolerable toxicity or patients withdrawal of consent |
|
| evaluation per 2 cycles (6 weeks) |
| SREs(Skeletal-related events) | measured pain, a fracture, the need for bone radiation or surgical therapy, spinal cord compression, or hypercalcemia | evaluation per 2 cycles (6 weeks) |
| Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | evaluation per 2 cycles (6 weeks) |