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Atezolizumab for High PD-L1 Stage IV Non-Small Cell Lung Cancer

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Study Aim

This study aims to evaluate if atezolizumab improves overall survival for people with high PD-L1 Stage IV Non-Small Cell Lung Cancer.

What is being tested

Atezolizumab

Drug
Who is being recruted

Bronchial Neoplasms+7

+ Carcinoma, Bronchogenic

+ Carcinoma, Non-Small-Cell Lung

Over 18 Years
+27 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: June 2022
See protocol details

Summary

Principal SponsorHoffmann-La Roche
Last updated: March 12, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 14, 2022

Actual date on which the first participant was enrolled.

This study focuses on evaluating the effectiveness and safety of a drug called atezolizumab for patients with an advanced form of lung cancer known as stage IV non-small cell lung cancer (NSCLC). The patients participating in this trial have not previously received chemotherapy and have high levels of a specific protein called PD-L1, which is found on the surface of some cancer cells. This study is important because it aims to offer a new treatment option for patients who have limited alternatives, especially those whose cancer cells have a high PD-L1 expression but do not have certain genetic mutations, making them more challenging to treat effectively. Participants in the study will receive atezolizumab, a medicine designed to help the immune system recognize and attack cancer cells, through an intravenous injection. The main goal of the study is to determine how long patients live after starting treatment with atezolizumab, which is referred to as overall survival. By closely monitoring these patients, researchers hope to understand better the potential benefits and any risks of this treatment in extending life expectancy for those with this specific type of lung cancer.

Official TitleA Phase III, Single-Arm Multicenter Study of Atezolizumab (Anti-PD-L1 Antibody) in High PD-L1 Expression, Chemotherapy-Naïve Patients With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer
Principal SponsorHoffmann-La Roche
Last updated: March 12, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic Neoplasms

Criteria

9 inclusion criteria required to participate
Patients who have received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy, or chemo-radiotherapy with curative intent for non-metastatic disease must have experienced a treatment free interval of at least 6 months from enrollment since the last chemotherapy, radiotherapy, or chemo-radiotherapy cycle

ECOG performance status of 0 or 1

Histologically or cytologically confirmed, Stage IV non-squamous or squamous NSCLC

Measurable disease, as defined by RECIST v1.1

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18 exclusion criteria prevent from participating
Known allergy or hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation

Active or history of autoimmune disease or immune deficiency

Active tuberculosis

Symptomatic, untreated, or actively progressing CNS metastases

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will receive IV infusion of atezolizumab on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by investigators.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 18 locations

Suspended

Beijing Tiantan Hospital,Capital Medical University

Beijing, ChinaOpen Beijing Tiantan Hospital,Capital Medical University in Google Maps
Suspended

Xuanwu Hospital, Capital Medical University

Beijing, China
Suspended

Beijing Chest Hospital

Beijing, China
Suspended

The Third Xiangya Hospital Of Central South University

Changsha, China
Suspended18 Study Centers