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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Atezolizumab will be administered at a dose of 1200 mg intravenously on Day 1 of each 21-day cycle.
Bevacizumab will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle.
Beijing Cancer Hospital
Beijing, China
Beijing Hospital; Internal Medicine-Oncology
Beijing, China
Beijing Chest Hospital; Oncology Department
Beijing, China
Objective Response Rate (ORR)
Objective response rate (ORR) was defined as the percentage of participants with a complete response (CR) or partial response (PR) on two consecutive occasions \>=4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).
Time frame: Baseline up to approximately 10 months
Duration of Objective Response (DOR)
Duration of objective response (DOR) was 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.
Time frame: Baseline up to approximately 2.5 years
Time to Response (TTR)
Time to response (TTR) was defined as the time from the start of the treatment to the first objective tumor response observed for participants who achieved CR or PR, as determined by the investigator according to RECIST v1.1.
Time frame: Baseline up to approximately 2.5 years
Disease Control Rate (DCR)
Disease control rate (DCR) was defined as the proportion of participants who have a best overall response of CR or PR or stable disease (SD), as determined by the investigator according to RECIST v1.1.
Time frame: Baseline up to approximately 2.5 years
Overall Survival (OS)
OS after enrollment was defined as the time from enrollment to death from any cause.
Time frame: Baseline until death due to any cause (up to approximately 2.5 years)
Progression-Free Survival (PFS)
Progression-free survival (PFS) was 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.
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West China Hospital, Sichuan University
Chengdu, China
Sun Yet-sen University Cancer Center
Guangzhou, China
Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department
Hangzhou, China
Harbin Medical University Cancer Hospital
Harbin, China
Shandong Cancer Hospital
Jinan, China
Guangxi Cancer Hospital of Guangxi Medical University
Nanning, China
The Affiliated Hospital of Medical College Qingdao University
Qingdao, China
Time frame: Baseline up to approximately 2.5 years
PFS Rate at 6 and 12 Months
PFS rate at 6 and 12 months is defined as the percentage of participants who have not experienced disease progression or death from any cause at 6 and 12 months, as determined by the investigator according to RECIST v1.1.
Time frame: Baseline to 6 months and 12 months
OS Rate at 1 and 2 Years
OS rate at 1 and 2 years was defined as the percentage of participants who have not experienced death from any cause at 1 and 2 years.
Time frame: Baseline to 1 and 2 Years
Percentage of Participants With Adverse Events
Percentage of participants with adverse events.
Time frame: Baseline up to approximately 2.5 years
Percentage of Participants With Serious and Non-Serious Immune-Mediated Adverse Events (irAEs)
Percentage of serious and non-serious immune-mediated adverse events related to atezolizumab treatment. The AESIs were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria. The grading is as follows: Grade 1=Mild AE, Grade 2=Moderate AE, Grade 3=Severe AE, Grade 4=Life-threatening or disabling AE, Grade 5=Death related to AE.
Time frame: Baseline up to approximately 2.5 years
Objective Response Rate (ORR) According to iRECIST
Objective response rate (ORR) is defined as the proportion of participants with a complete response (CR) or partial response (PR) on two consecutive occasions ≥4 weeks apart, as determined by the investigator according to Modified RECIST v1.1 (iRECIST).
Time frame: Baseline up to approximately 2.5 years
Disease Control Rate (DCR) According to iRECIST
Disease control rate (DCR) is defined as the proportion of participants who have a best overall response of CR or PR or stable disease (SD), as determined by the investigator according to modified RECIST v1.1 (iRECIST).
Time frame: Baseline up to 2 years and approximately 5 months
Duration of Objective Response (DOR) According to iRECIST
Duration of objective response (DOR) is 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 modified RECIST v1.1 (iRECIST).
Time frame: Baseline up to approximately 2.5 years
Progression-Free Survival (PFS) According to iRECIST
Progression-free survival (PFS) is 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 modified RECIST v1.1 (iRECIST).
Time frame: Baseline up to approximately 2.5 years
Progression-Free Survival (PFS) Rate at 12 Months According to iRECIST
Progression-free survival (PFS) rate is defined as the time from enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first at 12 months, as determined by the investigator according to modified RECIST v1.1 (iRECIST).
Time frame: Baseline up to approximately 12 months
Time to Deterioation (TTD) Using EORTC
Time to deterioration (TTD) using European Organization for Research and treatment of Cancer (EORTC) Quality-of-life Questionnaire Core 30 (QLQ C30) and its Lung Cancer Module (QLQ LC13) is defined as the time from baseline to the first time the patient's score shows a \>=10 points increase above baseline in any of the following EORTC-transformed symptom subscale scores (whichever occurs first): cough, dyspnoea (single item), dyspnoea (multi-item subscale), chest pain, or arm/shoulder pain, whichever occurred first. Scores ranged from 0-10. A higher score represented more severe symptoms.
Time frame: Baselsine up to approximately 1 year
Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status
The 30-item EORTC QLQ-C30 version 3 is composed by five multi-item function scales (physical, role, cognitive, emotional, and social), three multi-item symptom scales (fatigue, nausea and vomiting, and pain), six single-item symptom scales (dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties), and a two-item global quality of life scale. All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for the functional and general health areas represent better functional status and quality of life. Higher scores for the symptom scales represent more symptoms or problems (poor quality of life). A participant was classified as improved if a decrement of 10 points or worse was observed in the change from baseline scores. A participant was classified as worsened if a 10-point or greater increase was observed in the change from baseline scores.
Time frame: Baseline up to approximately 1 year
Change From Baseline in Lung Cancer Related Symptoms
The EORTC QLQ-LC13 is a specific module for lung cancer. It consists of 13 items covering lung cancer symptoms (dyspnoea, coughing, hemoptysis, pain in chest, pain in arm or shoulder and pain in other parts) and the side effects of chemo- and radiotherapy (alopecia, peripheral neuropathy, sore mouth, and dysphagia), which are divided into 10 fields, all are symptom types. All EORTC symptom scores are linearly transformed so that each score has a range of 0-100. A participant was classified as improved if a decrement of 10 points or worse was observed in the change from baseline scores. A participant was classified as worsened if a 10-point or greater increase was observed in the change from baseline scores.
Time frame: Baseline up to approximately 1 year