NON SMALL CELL LUNG CANCER
Conditions
Interventions
Tiragolumab: 600 mg administered by IV infusion every 3 weeks
Atezolizumab: 1200 mg administered by IV infusion every 3 weeks
Pemetrexed: 500 mg/m^2 administered by IV infusion every 3 weeks
Carboplat
Sponsors
Isabelle Rooney
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - ECOG PS of grade 0 or 1 - Histologically or cytologically documented locally advanced unresectable or metastatic non-squamous NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy - No prior systemic treatment for metastatic non-squamous NSCLC - Known tumor programmed death-ligand 1 (PD-L1) status - Measurable disease, as defined by RECIST v1.1 - Adequate hematologic and end-organ function - Negative HIV test at screening - Serology test negative for active hepatitis B virus or active hepatitis C virus at screening.
Exclusion criteria
Exclusion criteria: - Mutations in EGFR gene or ALK fusion oncogene - Pulmonary lymphoepithelioma-like carcinoma subtype of NSCLC - Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases - Active or history of autoimmune disease or immune deficiency - History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis - History of malignancy other than NSCLC within 5 years prior to randomization, with the exception of malignancies with a negligible risk of metastasis or death - Severe infection within 4 weeks prior to initiation of study treatment - Treatment with investigational therapy within 28 days prior to initiation of study treatment - Prior treatment with CD137 agonists or immune checkpoint blockade therapies - Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) - Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment - Known allergy or hypersensitivity to any component of the chemotherapy regimen - Women who are pregnant, or breastfeeding - Known targetable c-ROS oncogene 1 (ROS1) or BRAFV600E genomic aberration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy, Observation, Inspection, RECIST v1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, Efficacy, Phamacokinetics Observation, Inspection, RECIST v1.1 | — |
Countries
Belgium, Brazil, Canada, China, Denmark, France, Germany, Hong Kong, Italy, Japan, Kenya, Mexico, New Zealand, Poland, South Korea, Spain, Taiwan, Thailand, United Kingdom, United States
Contacts
Public ContactClinical trials information
Chugai Pharmaceutical Co., Ltd.
Outcome results
None listed