A Study of Tiragolumab in Combination With Atezolizumab Plus Pemetrexed and Carboplatin/Cisplatin Versus Pembrolizumab Plus Pemetrexed and Carboplatin/Cisplatin in Participants With Previously Untreated Advanced Non-Squamous Non-Small Cell Lung Cancer (SKYSCRAPER-06)
- Conditions
- Cancer
- Registration Number
- PACTR202301834998443
- Lead Sponsor
- Hoffmann La Roche
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 540
Eastern Cooperative Oncology Group (ECOG) Performance Status of 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 Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)
-Life expectancy >= 12 weeks
-Adequate hematologic and end-organ function
-Negative human immunodeficiency virus (HIV) test at screening
-Serology test negative for active hepatitis B virus or active hepatitis C virus at screening.
-Mutations in epidermal growth factor receptor (EGFR) gene or anaplastic lymphoma kinase (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 or any active infection that, in the opinion of the investigator, could impact patient safety
-Treatment with investigational therapy within 28 days prior to initiation of study treatment
-Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T lymphocyte-associated protein 4, anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies
-Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment
-Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment
-Known allergy or hypersensitivity or other contraindication to any component of the chemotherapy regimen the participant may receive during the study
-Women who are pregnant, or breastfeeding
-Known targetable c-ROS oncogene 1 (ROS1) or BRAFV600E genomic aberration.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method