Cancer
Conditions
Interventions
Tiragolumab plus Atezolizumab plus Pemetrexed plus Carboplatin or Cisplatin
Placebo plus Pembrolizumab plus Pemetrexed plus Carboplatin or Cisplatin
Sponsors
Hoffmann La Roche
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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.
Exclusion criteria
Exclusion criteria: -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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Investigator-Assessed Confirmed Objective Response Rate (ORR) (Phase 2) [ Time Frame: Up to approximately 5 years ] -Investigator-Assessed Progression-Free Survival (PFS) (Phase 2 and Phase 3) [ Time Frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 5 years [Phase 2], up to approximately 7 years [Phase 3]) ] -Overall Survival (Phase 3) [ Time Frame: From randomization to death from any cause (up to approximately 7 years) ] | — |
Secondary
| Measure | Time frame |
|---|---|
| -Overall Survival (Phase 2) [ Time Frame: From randomization to death from any cause (up to approximately 5 years) ] -PFS as Determined by an Independent Review Facility (IRF) (Phase 3) [ Time Frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 7 years) ] -Investigator-assessed PFS in Participants With PD-L1 Expression at TC =50% and TC =1% Cut-off, as Determined by Central Testing With Ventana PD-L1 (SP263) Assay (Phase 3) [ Time Frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 7 years) ] -OS in Participants With PD-L1 Expression at TC =50% and TC =1% Cut-off, as Determined by Central Testing With Ventana PD-L1 (SP263) Assay (Phase 3) [ Time Frame: From randomization to death from any cause (up to approximately 7 years) ] -Investigator-Assessed PFS at 6 Months and 12 Months (Phase 3) [ Time Frame: 6 months, 12 months ] -OS Rate at 12 Months and 24 Months (Phase 3) [ Time Frame: 12 months, 24 months ];-Investigator-Assessed Confirmed ORR (Phase 3) [ Time Frame: Up to approximately 7 years ] -Investigator-Assessed Duration of Response (DOR) (Phase 2 and Phase 3) [ Time Frame: From first occurrence of a documented confirmed objective response to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 5 years [Phase 2]; up to approximately 7 years [Phase 3]) ] -Time to Confirmed Deterioration (TTCD) in Participant-Reported Physical Functioning and Global Health Status (GHS)/Quality of Life (QoL) as Measured by European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 (Phase 2 and Phase 3) [ Time Frame: Up to approximately 5 years (Phase 2); up to approximately 7 years (Phase 3) ] TTCD using EORTC Quality-of-Life Questionnaire Core 30 (QLQ-C30) is an initial 10-point decrease in GHS and physical functioning fr | — |
Countries
Kenya
Contacts
Public ContactNour Ashraf
Clinical Operations Lead
Outcome results
None listed