The primary objective of the study is to evaluate the efficacy of osimertinib plus ramucirumab versus osimertinib alone using progression free survival (PFS). Events associated with PFS include: disease progression per RECIST 1.1 and death due to any cause. A total of 150 patients will be enrolled and randomized in a 2:1 fashion (osimertinib plus ramucirumab vs. osimertinib) to the two treatment arms according to the following stratification factors: types of epidermal growth factor receptor (EGFR) mutations and presence of brain metastasis.
Description: Progression free survival (PFS) time will be calculated from the date of randomization to disease progression or death from any cause, whichever occurs the first.Measure: Progression Free Survival (PFS) Time: 3 years
Description: Objective Response Rate (ORR) is defined as the number (%) of subjects with measurable disease with at least one visit response of complete response (CR) or partial response (PR). Data obtained up until progression, or last evaluable assessment in the absence of progression, will be included in the assessment of ORR.Measure: Objective Response Rate (ORR) Time: 1 year
Description: Disease control rate (DCR) is defined as the percentage of subjects who have a best overall response of CR or PR or stable disease (SD).Measure: Disease control rate (DCR) Time: 2 years
Description: Overall survival (OS) time is defined from the date of randomization to death date. A patient is censored at the last follow-up date if death has not been observed.Measure: Overall survival (OS) Time: 3 years
Description: Toxicities will be measured in frequency and severity using CTCAE v5Measure: Assess frequency and severity of adverse events Time: 2 years
There is one SNP
- NSCLC which harbors EGFR L858R mutation. --- L858R ---