This is a phase III, single-arm, multicenter study of the long-term safety and efficacy of atezolizumab treatment in patients with Stage IIIb or Stage IV non-small cell lung cancer (NSCLC) who have progressed following standard systemic chemotherapy (including if given in combination with anti-PD-1 therapy or after anti-PD-1 as monotherapy).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
101
Atezolizumab will be administered at a fixed dose of 1200 mg intravenously on the first day of each 21-day cycle.
Peking Union Medical College Hospital
Beijing, China
Sichuan Cancer Hospital
Chengdu, China
Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department
Hangzhou, China
Harbin Medical University Tumor Hospital; Department of Surgery; Pharmacy
Harbin, China
Serious Adverse Event Incidence Rates
The incidence of serious adverse events (SAEs) related to atezolizumab.
Time frame: Baseline up to approximately 3 years
Overall Survival (OS) Rate
Overall survival (OS) rate at 2 years, defined as the proportion of patients remaining alive 2 years after initiation of study treatment
Time frame: Baseline to 2 years
OS
Overall survival (OS), defined as the time from initiation of study treatment to death from any cause
Time frame: Baseline up to approximately 3 years
Progression-Free Survival (PFS)
Progression-free survival (PFS), defined as the time from initiation of study treatment to the first occurrence of disease progression or death from any cause, whichever occurs first.
Time frame: Baseline up to approximately 3 years
Objective Response Rate (ORR)
Objective response rate (ORR), defined as the percentage of patients who attain complete response (CR) or partial response (PR) according to RECIST v1.1 and also by disease status evaluated by the investigator according to modified RECIST
Time frame: Baseline up to approximately 3 years
Duration of Response (DOR)
Duration of response (DOR), defined as the time from initial response to disease progression or death among patients who have experienced a CR or PR (unconfirmed) during the study.
Time frame: Baseline up to approximately 3 years
EQ-5D-5L Index-Based and VAS scores
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Taizhou Hospital of Zhejiang Province
Linhai, China
Fudan University Shanghai Cancer Center; Medical Oncology
Shanghai, China
Cancer Hospital Affliated to Xinjiang Medical University
Ürümqi, China
EQ-5D-5L, EuroQol 5-Dimension Questionnaire is a self-report health status questionnaire that consists of six questions used to calculate a health utility score for use in health economic analysis. The EuroQol EQ-5D has two components: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort and anxiety/depression, as well as a visual analog scale (VAS) that measures health state. Overall scores range from 0 to 1, with low scores representing a higher level of dysfunction.
Time frame: Day 1 of first 3 cycles, then with tumor assessments every 6 weeks for 48 weeks from study treatment date; thereafter every 9 weeks until progressive disease or until treatment discontinuation (up to approximately 3 years)
EORTC QLQ-LC13 score
EORTC QLQ-LC13, European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Supplemental Lung Cancer Module will be used to assess self-reported outcomes. EORTC QLQ-LC13 includes 13 items that address key lung cancer symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related adverse effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. The dysphagia scale is multi-item, while the rest are single-item scales.
Time frame: Day 1 of first 3 cycles, then with tumor assessments every 6 weeks for 48 weeks from study treatment date; thereafter every 9 weeks until progressive disease or until treatment discontinuation (up to approximately 3 years)