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.
Name: Anlotinib
Description: Anlotinib 12mg qd on day 1 to 14 of a 21-day cycleType: DrugAnlotinib Plus Pemetrexed and Cisplatin
Name: pemetrexed
Description: pemetrexed 500mg/m2 on day 1 of a 21-day cycle ;Type: DrugAnlotinib Plus Pemetrexed and Cisplatin
Name: Cisplatin
Description: Cisplatin 75mg/m2 on day 1 of a 21-day cycle ;Type: DrugAnlotinib Plus Pemetrexed and Cisplatin
Description: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first
Measure: progression-free survival Time: From enrollment to completion of study. Estimated about 24 months.Description: Clinical response of treatment according to RESIST v1.1 criteria (ORR, Overall Response Rate)
Measure: Overall Response Rate Time: From enrollment to progression of disease. Estimated about 24 monthsDescription: Clinical response of treatment according to RESIST v1.1 criteria (DCR, disease control rate)
Measure: disease control rate Time: From enrollment to progression of disease. Estimated about 24 monthsDescription: From date of randomization until the date of death or date of last visit/contact, whichever came first
Measure: Overall Survival Time: From enrollment to completion of study. Estimated about 24 months.Description: Proportion of people who first documented disease progression or death from any cause, whichever came first ,during 6 months
Measure: 6-month PFS rate Time: From enrollment to analysis, Estimated about 6 monthsDescription: Proportion of people who first documented disease progression or death from any cause, whichever came first ,during 12 months
Measure: 12-month PFS rate Time: From enrollment to analysis. Estimated about 12 months.Single Group Assignment
There are 2 SNPs
recurrent patients, adjuvant chemotherapy, neoadjuvant chemotherapy or neoadjuvant chemotherapy plus adjuvant were assessed for eligibility, and the last treatment time must be more than 6 months before enrollment） - Patients have not been received systematic treatment，including chemotherapy and EGFR-TKIs - EGFR mutations confirmed by molecular detection (including, but not limited to, T790M, 19 exon deletion and L858R) external pathological examination was accepted (including pathological or blood test results) - There were at least one target lesions in the past three months has not yet accepted radiotherapy, and could be recorded by magnetic resonance imaging (MRI) or computer tomography (CT) measuring accurately at least in one direction(The maximum diameter needs to be recorded), including conventional CT ≥20 mm or spiral CT ≥10 mm. - Life expectancy ≥3 months. --- T790M --- --- L858R ---
recurrent patients, adjuvant chemotherapy, neoadjuvant chemotherapy or neoadjuvant chemotherapy plus adjuvant were assessed for eligibility, and the last treatment time must be more than 6 months before enrollment） - Patients have not been received systematic treatment，including chemotherapy and EGFR-TKIs - EGFR mutations confirmed by molecular detection (including, but not limited to, T790M, 19 exon deletion and L858R) external pathological examination was accepted (including pathological or blood test results) - There were at least one target lesions in the past three months has not yet accepted radiotherapy, and could be recorded by magnetic resonance imaging (MRI) or computer tomography (CT) measuring accurately at least in one direction(The maximum diameter needs to be recorded), including conventional CT ≥20 mm or spiral CT ≥10 mm. - Life expectancy ≥3 months. --- T790M ---