Non-squamous Non-small Cell Lung Cancer Clinical Trial
Official title:
A Randomized Phase II Study of Anlotinib Combined With Pemetrexed and Cisplatin in First Treatment for Advanced Non-small Cell Lung Cancer With Epidermal Growth Factor Receptor Negative Mutations
Chemotherapy is still the standard first-line treatment option for EGFR unmutated patients. After a randomized phase Ⅲ trial, BEYOND was presented the synergistic effect of progression-free survival(PFS) could be expected when chemotherapy is combined with Antiangiogenesis agent bevacizumab in China;Therefore,in this study, The investigators will investigate the efficacy and safety of Anlotinb combined With Pemetrexed and Cisplatin as first-line therapy in patients with chemotherapy-naive, stage IIIB or IV, non-squamous NSCLC without targetable EGFR or ALK genetic aberrations.
This is a randomized, single -center study conducted in China to compare the efficacy and
safety of Anlotinb combined With Pemetrexed and Cisplatin as first-line therapy in patients
of Advanced Gene Negative Non-squamous Non-small Cell Lung Cancer.
Eligible patients will be randomized to arm A:
Patients were instructed to take 500mg/m2 pemetrexed as a 10-minute intravenous infusion and
Cisplatin 75mg/m2 on day 1 of a 21-day cycle and12mg Anlotinib orally daily on day 1 to 14 of
a 21-day cycle.If there was no evidence of disease progression following a maximum of 4-6
cycles of anlotinib plus chemotherapy, patients continued to receive single-agent anlotinib
until disease progression or unacceptable toxicity. Approximately 62 patients will be
enrolled to ensure complete treatments for primary endpoint analysis.
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