A Phase 2 interventional study of Anlotinib Plus Docetaxel and Docetaxel in Non-small Cell Lung Cancer, sponsored by First Affiliated Hospital of Guangxi Medical University. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-08-31.
Sponsored by First Affiliated Hospital of Guangxi Medical University · Phase 2, Interventional, and Treatment
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,we envisage using anlotinib plus docetaxel treat the EGFR/ALK/ROS1 mutation-negative advanced nonsquamous Non-small cell lung cancer patients who were failure in the treatment of chemotherapy with platinum containing drugs, to further improve the patient's PFS or OS.
This is a multicentre randomised controlled clinical trial conducted in China to compare the effectiveness and safety of Anlotinib Plus Docetaxel in patients of EGFR/ALK/ROS1 mutation-negative Advanced nonsquamous Non-squamous Non-small Cell Lung Cancer.
Eligible patients will be randomized to arm A and arm B:
Arm A: Patients on the anlotinib and docetaxel arm received 75mg/m2 docetaxel as intravenous infusion on day 1 of a 21-day cycle and 12mg anlotinib orally daily on day 1to 14 of a 21-day cycle. Arm B: Patients on the docetaxel arm received 75mg/m2 docetaxel as intravenous infusion on day 1 of a 21-day cycle.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's planned enrollment of 84 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →First Affiliated Hospital of Guangxi Medical University is the lead sponsor of 41 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
Anlotinib (12mg QD PO d1-14, 21 days per cycle) and Docetaxel (75mg/m2 IV d1)
Drug: Anlotinib Plus Docetaxel
Docetaxel (75mg/m2 IV d1)
Drug: Docetaxel
Anlotinib (12mg QD PO d1-14, 21 days per cycle) and Docetaxel (75mg/m2 IV d1)
Docetaxel (75mg/m2 IV d1)
PFS
Progress free survival
Time frame: each 42 days up to PD or death(up to 24 months)
OS
Overall Survival
Time frame: From randomization until death (up to 24 months)
ORR
Objective Response Rate
Time frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
DCR
Disease Control Rate
Time frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
Safety (Number of Participants with Adverse Events as a Measure of Safety and Tolerability)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Until 21 day safety follow-up visit
No study locations are listed for this record.
This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
First Affiliated Hospital of Guangxi Medical University