Trials / Unknown
UnknownNCT03750916
Anlotinib Combined With Docetaxel for Advanced Non-squamous Non-Small Cell Lung Cancer
Anlotinib Combined With Docetaxel as Second-line Treatment of Patients With Wild-type Advanced Non-squamous NSCLC
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 46 (estimated)
- Sponsor
- Qilu Hospital of Shandong University · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Anlotinib is a multi-target receptor tyrosine kinase inhibitor in domestic research and development. It can inhibit the angiogenesis related kinase, such as VEGFR, FGFR, PDGFR, and tumor cell proliferation related kinase -c-Kit kinase. In the phase Ⅲ study, patients who failed at least two kinds of systemic chemotherapy (third line or beyond) or drug intolerance were treated with anlotinib or placebo, the anlotinib group PFS and OS were 5.37 months and 9.63 months, the placebo group PFS and OS were 1.4 months and 6.3 months. Therefore,envisage using anlotinib plus docetaxel treat the advanced Non-squamous non-small cell lung cancer to further improve the patient's PFS or OS.
Detailed description
This is a multicentre single arm clinical trial conducted in China,the purpose of this study is To Evaluate the Effectiveness and Safety of Anlotinib (12mg QD PO d1-14, 21 days per cycle)Combined with Docetaxel (75mg/m2 IV d1) for advanced Non-squamous non-small cell lung cancer.According to the result of TAX317,the PFS of second line standard chemotherapy was 3 month. Expected the PFS was 5.7. Using PASS11, That calculated the sample size of this study was 41 , according to 10% censoring,the expected sample size is 46.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Anlotinib Hydrochloride plus Docetaxel | Anlotinib Hydrochloride (12mg QD PO d1-14, 21 days per cycle) and Docetaxel (75mg/m2 IV d1) |
Timeline
- Start date
- 2018-11-30
- Primary completion
- 2020-11-30
- Completion
- 2020-11-30
- First posted
- 2018-11-23
- Last updated
- 2018-11-26
Source: ClinicalTrials.gov record NCT03750916. Inclusion in this directory is not an endorsement.