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Clinical Trials in China / NCT05047250
Active, not recruiting Phase 3

A Study of Atezolizumab in High PD-L1 Expression, Chemotherapy-Naïve Patients With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer

NCT05047250 · tracked via the Priya Life Science China tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Started
2022-06-14
Last updated
2026-07-02

Condition(s) studied

Non-Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Atezolizumab

Atezolizumab: Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by investigators.

Study summary

This is a Phase III, single arm, multicenter study designed to evaluate the efficacy and safety of atezolizumab in high PD-L1 expression, chemotherapy-naïve, without a sensitizing EGFR mutation or ALK translocation patients with stage IV non-squamous or squamous NSCLC.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * ECOG performance status of 0 or 1. * Histologically or cytologically confirmed, Stage IV non-squamous or squamous NSCLC. * No prior treatment for Stage IV non-squamous or squamous NSCLC. * 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. * Tumor TC3 or IC3, as determined by SP142 performed by a central laboratory on previously obtained archival tumor tissue or tissue obtained from a biopsy at screening. * Measurable disease, as defined by RECIST v1.1. * Adequate hematologic and end-organ function. * Life expectancy ≥3 months. * For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating. Exclusion Criteria: * Known sensitizing mutation in the EGFR gene or ALK fusion oncogene. * Symptomatic, untreated, or actively progressing CNS metastases. * Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≥2 weeks prior to enrollment. * Current leptomeningeal disease. * Uncontrolled tumor-related pain. * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures. * Uncontrolled or symptomatic hypercalcemia. * Malignancies other than NSCLC within 5 years prior to enrollment, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome. * Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within at least 5 months after the last dose of atezolizumab. * History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins. * 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. * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. * Positive human immunodeficiency virus (HIV) test result at screening. * Patients with active hepatitis B or active hepatitis C at screening. * Active tuberculosis. * Severe infections within 4 weeks prior to randomization, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia. * Significant cardiovascular disease.

Primary outcome measure(s)

Trial sites (18)

FacilityCityRegionStatus
Beijing Tiantan Hospital,Capital Medical University Beijing China
Xuanwu Hospital, Capital Medical University Beijing China
Beijing Chest Hospital Beijing China
The Third Xiangya Hospital Of Central South University Changsha China
Daping Hospital of Third Military Medical University Chongqing China
Fujian Cancer Hospital Fuzhou China
Sir Run Run Shaw Hospital Zhejiang University Hangzhou China
Anhui Province Cancer Hospital Hefei China
The First Affiliated Hospital of Anhui Medical University Hefei China
Linyishi Cancer Hospital Linyi China
Nanjing Chest Hospital Nanjing China
Shanghai Chest Hospital Shanghai China
Cancer Hospital of Shantou University Medical College Shantou China
Tianjin Medical University General Hospital Tianjin China
Tianjin Cancer Hospital Tianjin China
Tumor Center,Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan China
Renmin Hospital of Wuhan University Wuhan China
The First Affiliated Hospital of Xiamen University Xiamen China

On this site

📄 Tecentriq (atezolizumab) drug profile →

More Hoffmann-La Roche trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05047250 on ClinicalTrials.gov ↗ ← All trials in China