Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer (NSCLC) MedDRA version: 21.1 Level: PT Classification code 10059515 Term: Non-small cell lung cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age >= 18 years - ECOG performance status of 0 or 1 - Histologically or cytologically confirmed, Stage IV non-squamous or squamous NSCLC - No prior treatment for Stage IV non-squamous or squamous NSCLC • Patients known to have a sensitizing mutation in the EGFR gene or an ALK fusion oncogene are excluded from the study. - Patients with a history of treated asymptomatic CNS metastases are eligible provided they meet certain criteria - Tumour PD-L1 expression as determined by an IHC assay performed by a central laboratory on previously obtained archival tumour tissue or tissue obtained from a biopsy at screening - Measurable disease, as defined by RECIST v1.1 - Adequate hematologic and end-organ function Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 380 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 175
Exclusion criteria
Exclusion criteria: - Known sensitizing mutation in the EGFR gene or ALK fusion oncogene - Active or untreated CNS metastases as determined by CT or MRI evaluation during screening - Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death - History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjögren’s syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis - History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan - Patients with positive test for HIV, active hepatitis B or hepatitis C, or active tuberculosis - Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction or cerebrovascular accident within 3 months prior to randomization, unstable arrhythmias, or unstable angina - Treatment with any other investigational agent with therapeutic intent within 28 days prior to randomization - Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-PD-1, and anti-PD-L1 therapeutic antibodies - History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •The primary objective for this study is to evaluate the efficacy of atezolizumab compared with platinum-based chemotherapy consisting of a platinum agent (cisplatin or carboplatin) in combination with either pemetrexed (non-squamous disease) or gemcitabine (squamous disease) in chemotherapy-naive patients with Stage IV NSCLC as measured by OS.;Secondary Objective: •To evaluate the efficacy of atezolizumab compared with chemotherapy as measured by investigator-assessed progression free survival (PFS), overall response rate (ORR), duration of response (DOR) according to RECIST v1.1 •To evaluate the efficacy of atezolizumab compared with chemotherapy as measured by OS and PFS according to RECIST v1.1 in patients with PD-L1 expression defined by the SP263 IHC assay and with high blood mutational burden (bTMB) •To evaluate the OS rate at 1- and 2- year landmark time points in each arm •To determine the impact of atezolizumab compared with chemotherapy as measured by time to deterioration (TTD) and change from baseline each of the patient reported lung cancer symptom score as assessed by the SILC scale • To determine the impact of atezolizumab compared with chemotherapy as measured by TTD in patient-reported lung cancer symptoms of cough, dyspnea chest pain as measured by the EORTC, QLQ-C30 and QLQ-LC13;Primary end point(s): OS, defined as the time from randomization to death from any cause;Timepoint(s) of evaluation of this end point: Approximately 55 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. PFS, defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator with use of RECIST v1.1, or death from any cause, whichever occurs first 2. Objective response, defined as partial response (PR) plus complete response (CR), as determined by the investigator according to RECIST v1.1 3.DOR, defined as the time from the first occurrence of a documented objective response to the time of disease progression, as determined by the investigator with use of RECIST v1.1, or death from any cause, whichever occurs first 4.OS and investigator-assessed PFS according to RECIST v1.1 in the PD-L1 (defined with SP263 IHC assay) and bTMB subpopulations 5.1-year OS and 2-year OS 6.TTD and change from baseline in each of the patient- reported lung cancer symptoms (cough, dyspnoea, or chest pain, whichever occurs first) with use of the SILC scale 7. TTD in patient-reported lung cancer symptoms, defined as time from randomization to deterioration in any of the following symptom subscales (cough, dyspnea [multi-item scale], and chest pain), whichever occurs first, as measured by the EORTC QLQ-LC13;Timepoint(s) of evaluation of this end point: 1-7. Approximately 55 months | — |
Countries
Brazil, Canada, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Korea, Republic of, Philippines, Poland, Romania, Russian Federation, Serbia, Spain, Turkey, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
F.Hoffmann-La Roche Ltd
Outcome results
None listed