Trial Outcomes & Findings for A Study of Atezolizumab (Tecentriq) to Investigate Long-term Safety and Efficacy in Previously-treated Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) (NCT NCT03285763)

Participants were enrolled at 111 sites across 24 countries.

Four enrolled participants died without receiving study treatment.

A Study of Atezolizumab (Tecentriq) to Investigate Long-term Safety and Efficacy in Previously-treated Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unitended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a pharmaceutical product whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as a AEs.

The overall survival (OS) rate at 2 years, was defined as the percentage of participants remaining alive 2 years after initiation of study treatment.

OS was defined as the time (in months) from initiation of study treatment to death from any cause.

PFS was defined as the time (in months) from initiation of study treatment to the first documented disease progression or death from any cause, whichever occurred first. PFS was evaluated by the investigator according to RECIST v1.1.

The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L 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 Analogue Scale (VAS) that measures health state. Each item was rated from 1 (no problems) to 5 (extreme problems). Categories with non-zero values are reported here. Number of participants who rated the mobility item ranging from 1-5 are reported. Participants who had a invalid response were presented under the category 'Invalid Response'.

The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L 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 VAS that measures health state. Each item was rated from 1 (no problems) to 5 (extreme problems). Categories with non-zero values are reported here. Number of participants who rated the self-care item ranging from 1-5 are reported. Participants who had a invalid response were presented under the category 'Invalid Response'.

The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L 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 VAS that measures health state. Each item was rated from 1 (no problems) to 5 (extreme problems). Categories with non-zero values are reported here. Number of participants who rated the usual activities item ranging from 1-5 are reported. Participants who had a invalid response were presented under the category 'Invalid Response'.

The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L 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 VAS that measures health state. Each item was rated from 1 (no problems) to 5 (extreme problems). Categories with non-zero values are reported here. Number of participants who rated the pain/discomfort item ranging from 1-5 are reported. Participants who had a invalid response were presented under the category 'Invalid Response'.

The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L 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 VAS that measures health state. Each item was rated from 1 (no problems) to 5 (extreme problems). Categories with non-zero values are reported here. Number of participants who rated the anxiety/depression item ranging from 1-5 are reported. Participants who had a invalid response were presented under the category 'Invalid Response'.

The EQ-5D-5L was a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score for use in health economic analysis. The EQ-5D-5L 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 VAS that measures health state. The VAS is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. Values presented after baseline represent the change from baseline.

The EORTC QLQ-LC13 consisted of 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. The scales are linearly transformed so that each score has a range from 0 to 100. A high scale score represents a higher response level (e.g. a high score for global health status represents a high QoL). A high score for the symptom scale represents a high level of symptoms. A \>=10-point change in the EORTC scale score was perceived by participants as clinically significant. Values presented after baseline represent the change from baseline.