Clinical trial NCT05047250: A Study of Atezolizumab in High PD-L1 Expression, Chemotherapy-Naïve Patients With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer
Official title: A 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2021-09-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 criteria: 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 outcomes:
measure: Overall survival (OS)
timeFrame: Atezolizumab initiation to death from any cause (up to approximately 28 months)
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Atezolizumab initiation to the first occurrence of disease progression or death from any cause (whichever occurs first), (up to approximately 28 months)
measure: OS Rate at 1-Year
timeFrame: Atezolizumab initiation to 1-year
measure: OS Rate at 2-Year
timeFrame: Atezolizumab initiation to 2-year
measure: Objective Response Rate (ORR)
timeFrame: Randomization up to approximately 34 months
measure: Duration of Response (DOR)
timeFrame: Randomization up to approximately 34 months
measure: Percentage of Participants With Adverse Events
timeFrame: Randomization up to approximately 34 months
Other outcomes:
Locations:
city: Beijing City
country: China
facility: Xuanwu Hospital, Capital Medical University
city: Beijing
country: China
facility: Beijing Tiantan Hospital,Capital Medical University
city: Beijing
country: China
facility: Beijing Chest Hospital
city: Changsha
country: China
facility: The Third Xiangya Hospital Of Central South University
city: Changzhou
country: China
facility: Changzhou First People's Hospital
city: Chongqing
country: China
facility: Daping Hospital of Third Military Medical University
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
city: Hangzhou City
country: China
facility: Sir Run Run Shaw Hospital Zhejiang University
city: Hangzhou
country: China
facility: The Second Affiliated Hospital, Zhejiang University
city: Hefei City
country: China
facility: Anhui Province Cancer Hospital
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
city: Jinzhou City
country: China
facility: The First Affiliated Hospital Of Jinzhou Medical University
city: Kunming City
country: China
facility: Yunnan Cancer Hospital
city: Linyi City
country: China
facility: Linyishi Cancer Hospital
city: Nanjing City
country: China
facility: Nanjing Chest Hospital
city: Nanjing City
country: China
facility: Jiangsu Cancer Hospital
city: Shanghai
country: China
facility: Shanghai Chest Hospital
city: Shantou
country: China
facility: Cancer Hospital of Shantou University Medical College
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
city: Wuhan
country: China
facility: Tumor Center,Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: