None listed
Conditions
Interventions
Intervention1: Atezolizumab: The dose of atezolizumab in this study will be 1200 mg administered by intravenous infusion on Day 1 of each 21-day cycle.
Control Intervention1: Vinorelbine [oral or intr
Sponsors
F HoffmannLa Roche Ltd
Roche Products India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Signed Informed Consent Form 2. Women or men aged =18 years 3. Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC 4. No sensitizing epidermal growth factor receptor (EGFR) mutation (L858R or exon 19 deletions) or anaplastic lymphoma kinase (ALK) fusion oncogene detected 5. No prior systemic treatment for advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC 6.Life expectancy = 8 weeks 7.Deemed unsuitable for platinum-containing chemotherapy by the investigator due to poor performance status (ECOG PS of 2-3) 8. Measurable disease, as defined by RECIST v1.1. 9. For female patients of childbearing potential and male patients with partners of childbearing potential randomized to the treatment arm: agreement (by patient and/or partner) to remain abstinent (refrain from heterosexual intercourse) or to use highly effective form(s) of contraceptive methods that result in a failure rate of
Exclusion criteria
Exclusion criteria: 1. Active or untreated CNS metastases 2. Uncontrolled tumor-related pain 3. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). 4. NCI CTCAE (v4.0) Grade 3 or higher toxicities due to any prior therapy (e.g., radiotherapy) (excluding alopecia), which have not shown improvement and are strictly considered to interfere with current study medication 5. Pregnant or lactating women, or intending to become pregnant during the study. 6.History of autoimmune disease 7.History of idiopathic pulmonary fibrosis (IPF), organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. 8.Known positivity for human immunodeficiency virus (HIV) 9.Known active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or known active hepatitis C 10. Active tuberculosis 11.Severe infections within 4 weeks prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia 12.Significant cardiovascular disease, such as New York Heart Association (NYHA) cardiac disease (Class II or greater), myocardial infarction within 3 months prior to randomization, unstable arrhythmias, or unstable angina 13. Major surgical procedure other than for diagnosis within 4 weeks prior to randomization or anticipation of need for a major surgical procedure during the course of the study 14. Prior allogeneic bone marrow transplantation or solid organ transplant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective for this study is to evaluate the efficacy of atezolizumab compared with single agent chemotherapy in patients with treatment-naïve locally advanced or metastatic NSCLC who are deemed unsuitable for platinum-containing therapy.Timepoint: Measured by overall survival (OS). | — |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory Objectives: To evaluate the efficacy with respect to antitumor effects as measured by investigator-assessed ORR, PFS, DOR and disease control rates (DCR) according to modified RECIST. To evaluate the relationship between - the main efficacy endpoints and tumor tissue PD-L1 expression - the main efficacy endpoints and exploratory biomarkers in tumor tissue and plasma - the main efficacy endpoints and the expression of immune markers in PBMCs Timepoint: ORR, PFS, DOR and DCR as determined per modified RECIST v1.1. Tumor tissue PD-L1 expression Exploratory biomarkers in tumor tissue and plasma Expression of immune markers in PBMCs Utility scores of the EQ-5D-5L questionnaire ;Patient-reported Outcome Objectives: To evaluate and compare PROs of lung cancer symptoms, patient functioning, and health-related quality of life (HRQoL) between treatment arms as measured by the European Organisation for Research and treatment of Cancer (EORTC) Quality-of-life Questionnaire Core 30 (QLQ C30) and its Lung Cancer Module (QLQ LC13) Timepoint: Change from baseline in PROs of lung cancer symptoms, patient functioning, HRQoL as assessed by EORTC QLQ-C30 and its supplementary Lung Cancer module (LC13). TTD in patient-reported lung cancer symptoms of cough, dyspnea (single-item and multi-item subscales), chest pain, arm/shoulder pain, or fatigue using EORTC QLQ-C30 and QLQ-LC13.;Safety Objectives To evaluate the safety and tolerability of atezolizumab compared with single agent chemotherapy Timepoint: Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v4.0. Changes in vital signs, physical findings, and clinical laboratory results during and following study drug administration;Secondary Efficacy Objectives: The secondary efficacy objectives for this study are to evaluate the efficacy of atezolizumab compared with single agent chemotherapy as measured by OS rates at 6, 12, 18 and 24 months, antitumor effects as | — |
Countries
Algeria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Czech Republic, Denmark, Germany, India, Ireland, Italy, Kazakhstan, Luxembourg, Mexico, Peru, Poland, Portugal, Romania, Slovakia, Spain, Switzerland, United Kingdom, Viet Nam
Contacts
Public ContactAmol Pawar
Roche Products (India) Pvt. Ltd.
Outcome results
None listed