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

Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05047250
• Other study ID #: ML42606
• Status: Recruiting
• Phase: Phase 3
• Start date: June 14, 2022
• Est. completion date: August 31, 2027

Study information

• Verified date: May 2024
• Source: Hoffmann-La Roche
• Contact: Reference Study ID Number: ML42606 https://forpatients.roche.com
• Phone: 888-662-6728 (U.S. and Canada)
• Email: global.rochegenentechtrials[@]roche.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 31, 2027
• Est. primary completion date: February 28, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Beijing Chest Hospital; Oncology Department	Beijing
China	Xuanwu Hospital, Capital Medical University	Beijing City
China	The Third Xiangya Hospital Of Central South University	Changsha
China	Changzhou First People's Hospital	Changzhou
China	Sichuan Cancer Hospital	Chengdu City
China	Daping Hospital of Third Military Medical University	Chongqing
China	Fujian Cancer Hospital	Fuzhou
China	Nanfang Hospital, Southern Medical University	Guangzhou
China	The First Affilicated Hospital, Sun Yat-sen University	Guangzhou City
China	The Second Affiliated Hospital, Zhejiang University	Hangzhou
China	Sir Run Run Shaw Hospital Zhejiang University	Hangzhou City
China	Harbin Medical University Cancer Hospital	Harbin
China	The First Affiliated Hospital of Anhui Medical University	Hefei
China	Anhui Province Cancer Hospital	Hefei City
China	Shandong Cancer Hospital	Jinan
China	The First Affiliated Hospital Of Jinzhou Medical University	Jinzhou City
China	Yunnan Cancer Hospital	Kunming City
China	Linyishi Cancer Hospital	Linyi City
China	Jiangsu Cancer Hospital	Nanjing City
China	Nanjing Chest Hospital	Nanjing City
China	Shanghai Chest Hospital	Shanghai
China	Cancer Hospital of Shantou University Medical College	Shantou
China	Tianjin Cancer Hospital	Tianjin
China	Tianjin Medical University General Hospital	Tianjin
China	Renmin Hospital of Wuhan University	Wuhan
China	Tumor Center,Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan
China	The First Affiliated Hospital of Xiamen University	Xiamen
China	Xuzhou Central Hospital	Xuzhou

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)	Overall survival (OS) is defined as the time from atezolizumab initiation to death from any cause.	Atezolizumab initiation to death from any cause (up to approximately 28 months)
Secondary	Progression-free survival (PFS)	Progression-free survival (PFS) is defined as the time from atezolizumab initiation to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by investigators according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).	Atezolizumab initiation to the first occurrence of disease progression or death from any cause (whichever occurs first), (up to approximately 28 months)
Secondary	OS Rate at 1-Year	OS rate at 1-year is defined as the probability of participants who have not experienced death from any cause at 1-year after atezolizumab initiation.	Atezolizumab initiation to 1-year
Secondary	OS Rate at 2-Year	OS rate at 2-year is defined as the probability of participants who have not experienced death from any cause at 2-year after atezolizumab initiation.	Atezolizumab initiation to 2-year
Secondary	Objective Response Rate (ORR)	Objective response rate (ORR) is defined as the proportion of participants with a complete response (CR) or partial response (PR), as determined by investigators according to RECIST v1.1.	Randomization up to approximately 34 months
Secondary	Duration of Response (DOR)	Duration of response (DOR) is defined as the time from the first occurrence of an objective response to disease progression or death from any cause (whichever occurs first), as determined by investigators according to RECIST v1.1.	Randomization up to approximately 34 months
Secondary	Percentage of Participants With Adverse Events	Percentage of participants with adverse events.	Randomization up to approximately 34 months