Non-squamous Non-small Cell Lung Cancer Clinical Trial
Official title:
Dose Climbing Trial of Anlotinib Plus Pemetrexed/Docetaxel in the Second-line Treatment of Advanced Gene Negative Non-squamous Non-small Cell Lung Cancer
The purpose of this clinical study is to evaluate the tolerability and toxicity of different dose of Anlotinib puls Pemetrexed/Docetaxel in Second-line Treatment of Advanced Gene Negative Non-squamous Non-small Cell Lung Cancer , to provide a reference of dosage for Phase II clinical trials
This is a randomized, single -center study conducted in China to compare the tolerability and
toxicity of different dose of Anlotinib Plus Pemetrexed / Docetaxel in patients of Advanced
Gene Negative Non-squamous Non-small Cell Lung Cancer.From low dose group up to high dose
group, each one had 3 patients at least.Primary group received anlotinib 8mg. The dose of
Anlotinib would increase gradually until MTD.
Eligible patients will be randomized to arm A and arm B:
Arm A: Patients were instructed to take folic acid 400ug orally daily beginning 1 week before
the first dose of pemetrexed and continuing daily until 3 weeks after the last dose of
pemetrexed. A 1000ug B12 injection was administered intramuscularly approximately 1 week
before the first dose of pemetrexed and was repeated approximately every 9 weeks until after
discontinuation. All target volumes were instructed to take dexamethasone (4 mg orally twice
daily the day before, the day of, and the day after pemetrexed) as a prophylactic measure
against skin rash. Patients on the pemetrexed arm received 500mg/m2 pemetrexed as a 10-minute
intravenous infusion on day 1 of a 21-day cycle and 8mg/10mg/12mg Anlotinib orally daily on
day 1 to 14 of a 21-day cycle.
Arm B: Patients on the docetaxel arm received 60mg/m2 docetaxel as a 10-minute intravenous
infusion on day 1 of a 21-day cycle and 8mg/10mg/12mg anlotinib orally daily on day 1to 14 of
a 21-day cycle.
Approximately 18 patients will be enrolled to ensure that roughly 9 patients per arm complete
treatments for primary endpoint analysis.
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