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A Study of Atezolizumab Compared With Platinum Doublet Chemotherapy for PD-L1 Highly Expressed, Chemotherapy-Naïve Patients With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer
- Cancer
- Lung Cancer
- Non-Small Cell Lung Cancer (NSCLC)
Please note that the recruitment status of the trial at your site may differ.
Trial Status:
Recruiting
This trial runs in
Countries
- China
- United States
Trial Identifier:
NCT05047250 ML42606
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.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT05047250,ML42606
Trial Identifier
Atezolizumab
Treatments
Non-Small Cell Lung Cancer
Condition
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
Eligibility Criteria
All
Gender
≥18 Years
Age
No
Healthy Volunteers
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.
For the latest version of this information please go to www.forpatients.roche.com