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)
Overall survival (OS) — Atezolizumab initiation to death from any cause (up to approximately 28 months) Overall survival (OS) is defined as the time from atezolizumab initiation to death from any cause.
Trial sites (18)
Facility
City
Region
Status
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
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.
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