Non-Small Cell Lung Cancer
Conditions
Brief summary
The purpose of the study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in participants with previously untreated locally advanced, unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. Eligible participants will be randomized in a 1:1 ratio to receive either tiragolumab plus atezolizumab or placebo plus atezolizumab.
Interventions
DRUGAtezolizumab
Atezolizumab 1200 milligrams (mg) administered by intravenous (IV) infusion Q3W on Day 1 of each 21-day cycle.
DRUGTiragolumab
Tiragolumab 600 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.
DRUGMatching Placebo
Matching Placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Histologically or cytologically documented locally advanced or recurrent NSCLC not eligible for curative surgery and/or definitive radiotherapy with or without chemoradiotherapy, or metastatic Stage IV non-squamous or squamous NSCLC * No prior systemic treatment for metastatic NSCLC * High tumor tissue PD-L1 expression * Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) * Adequate hematologic and end-organ function * For participants enrolled in the extended China enrollment phase: current resident of mainland China or Taiwan and of Chinese ancestry.
Exclusion criteria
* Known mutation in the EGFR gene or an ALK fusion oncogene * Symptomatic, untreated, or actively progressing central nervous system 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 * Malignancies other than NSCLC within 5 years, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome * Severe infection within 4 weeks prior to initiation of study treatment * Positive test result for human immunodeficiency virus (HIV) * Active hepatitis B or hepatitis C * Treatment with investigational therapy within 28 days prior to initiation of study treatment * Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-CTLA-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 prior to initiation of study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigator-Assessed Progression-Free Survival (PFS) in the Primary Analysis Set | From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 59 months) |
| Overall Survival (OS) in the Primary Analysis Set | From randomization to death from any cause (up to approximately 59 months) |
| Percentage of Participants With Adverse Events (AEs) | Up to approximately 59 months |
| Percentage of Participants With Cytokine-Release Syndrome (CRS) | Up to approximately 59 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator-Assessed PFS in the Secondary Analysis Set | From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 59 months) | — |
| OS in the Secondary Analysis Set | From randomization to death from any cause (up to approximately 59 months) | — |
| Investigator-Assessed Confirmed Objective Response Rate (ORR) | From randomization up to approximately 59 months | — |
| Investigator-Assessed Duration of Response (DOR) | From the first occurrence of a documented confirmed objective response to disease progression or death from any cause, whichever occurs first (up to approximately 59 months) | — |
| Investigator-Assessed PFS Rates at 6 Months and 12 Months | 6 months, 12 months | — |
| OS Rates at 12 Months and 24 Months | 12 months, 24 months | — |
| Time to Confirmed Deterioration (TTCD) Assessed Using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core (QLQ-C30) Score | From randomization until the first confirmed clinically meaningful deterioration (up to approximately 59 months) | TTCD using EORTC QLQ-C30 is an initial 10-point decrease in global health status (GHS)/quality of life (QoL) and functioning from baseline that must be held for at least two consecutive assessments or an initial clinically meaningful decrease above baseline followed by death. EORTC QLQ-C30: a self-reported measure, consisting of 30 questions that assess 5 aspects of participants functioning (physical, emotional, role, cognitive and social), 3 symptom scales (fatigue, nausea and vomiting and pain), GHS and QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) with a recall period of the previous week. Functioning items are scored on a 4-point scale: 1=Not at all to 4=Very much, with higher score indicating worse outcome. Symptom items (GHS and QoL) are scored on a 7-point scale: 1=Very poor to 7=Excellent. Scores will be linearly transformed with a minimum score of 0 and maximum score of 100. Higher score indicates better outcome. |
Countries
Australia, Austria, Brazil, China, Germany, Greece, Hungary, Italy, Japan, Mexico, Netherlands, Peru, Poland, Russia, Serbia, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United States
Contacts
STUDY_DIRECTORClinical Trial
Hoffmann-La Roche
Outcome results
None listed