This is an open-label, single-arm, phase II, multicenter study designed to evaluated the efficacy and safety of atezolizumab in combination with bevacizumab in PD-L1-selected patients with Stage IIIB/IV Non-Squamous NSCLC harbored EGFR mutation after EGFR TKI therapy.
Name: Atezolizumab
Name: Bevacizumab
Description: PFS rate at 6 months, defined as the proportion of participants who have not experienced disease progression or death from any cause at 6 months after enrollment, as determined by the investigator according to RECIST v1.1
Measure: Progression Free Survival (PFS) Rate at 6 Months Time: 6 monthsDescription: Objective response rate (ORR), defined as the proportion of patients with a complete response (CR) or partial response (PR) on two consecutive occasions ≥4 weeks apart, as determined by the investigator according to RECIST v1.1
Measure: Objective Response Rate (ORR) Time: Baseline up to approximately 3 yearsDescription: Duration of objective response (DOR), defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause whichever occurs first, as determined by the investigator according to RECIST v1.1.
Measure: Duration of Objective Response (DOR) Time: Baseline up to approximately 3 yearsDescription: Time to response (TTR), defined as the time from the start of the treatment to the first objective tumor response observed for patients who achieved CR or PR, as determined by the investigator according to RECIST v1.1.
Measure: Time to Response (TTR) Time: Baseline up to approximately 3 yearsDescription: Overall survival (OS) after enrollment, defined as the time from enrollment to death from any cause.
Measure: Overall Survival (OS) Time: Baseline until death due to any cause (up to approximately 3 years)Description: Progression-free survival (PFS), defined as the time from enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first, as determined by the investigator according to RECIST v1.1
Measure: Progression-Free Survival (PFS) Time: Baseline up to approximately 3 yearsDescription: PFS rate at 12 months, defined as the proportion of patients who have not experienced disease progression or death from any cause at 12 months, as determined by the investigator according to RECIST v1.1.
Measure: PFS Rate at 12 Months Time: 12 monthsDescription: OS rate at 1 and 2 years, defined as the proportion of patients who have not experienced death from any cause at 1 and 2 years.
Measure: OS Rate at 1 and 2 Years Time: 1 and 2 YearsDescription: Incidence of serious and non-serious immune-related adverse events (irAEs) related to atezolizumab treatment.
Measure: Incidence of Serious and Non-Serious Immune-Related Adverse Events (irAEs) Time: Baseline up to approximately 3 yearsDescription: Participants will be tested by two kits - SP 142 and SP 263. Positive results from SP142 or SP263 will be accepted. Sp142 +/Sp263- and Sp142-/ SP263+ (cutoff data is 1% positive) data will be collected to do the consistency test by x2-test.
Measure: Consistency Among in SP 142 and SP 263 Time: Baseline up to approximately 12 monthsAllocation: N/A
Single Group Assignment
There is one SNP
Patients who have progressed on or were intolerant to first- or second-generation EGFR TKIs, and who have no evidence of the EGFR T790M mutation after TKI therapy are eligible. --- T790M ---
Patients who have progressed on or were intolerant to first- or second-generation EGFR TKIs and who have evidence of the T790M mutation must have also progressed on or were intolerant to osimertinib to be eligible. --- T790M ---