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Brief Title: Non Squamous NSCLC Patients With Anlotinib Combined With Pemetrexed and Cisplatin
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
Study ID: NCT03671538
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No