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
- Non-Small Cell Lung Cancer
Recruiting
- China
- United States
NCT05047250 ML42606
Trial Summary
This is a Phase III, randomized study to evaluate the efficacy and safety of atezolizumab compared with platinum-based chemotherapy consisting of a platinum agent (carboplatin or cisplatin) in combination with pemetrexed (non-squamous disease) OR gemcitabine or paclitaxel (squamous disease) in highly PD-L1 expressed, chemotherapy-naïve, EGFR/ALK wild type patients with stage IV non-squamous or squamous NSCLC.
A Phase III, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) 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
Eligibility 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 randomization 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.
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm.
- 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 randomization.
- 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 randomization, 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 and 6 months for chemotherapy.
- 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.
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