Non-Small Cell Lung Cancer (NSCLC) MedDRA version: 21.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer 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 at time of signing Informed Consent Form •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 •For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, during the treatment period and for 5 months after the final dose of atezolizumab •Adequate hematologic and end-organ function •For participants receiving therapeutic anticoagulation: stable anticoagulant regimen •Intact normal skin without potentially obscuring tattoos, pigmentation, or lesions in the area for intended injection •Negative HIV and hepatitis B surface antigen (HBsAg) test at screening •Positive hepatitis B surface antibody (HBsAb) test at screening, or negative HBsAb at screening accompanied by either of the following: - Negative total hepatitis B core antibody (HBcAb) - Positive total HBcAb test followed by a negative (per local laboratory definition) hepatitis B virus (HBV) DNA test The HBV DNA test must be performed for participants who have a negative HBsAg test, a negative HBsAb test, and a positive total HBcAb test •Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening •If a port for IV delivery is present, acceptance to receive atezolizumab IV, and any other IV medication which may be required, through a peripheral line Participants with Early-stage NSCLC •Participants must have a complete resection of a histologically or cytologically confirmed Stage II, IIIA, and selected IIIB (T3-N2) NSCLC •Programmed death-ligand 1 (PD-L1) expression >=1%, as documented through local or central testing of a representative tumor tissue specimen •Participants must have completed adjuvant chemotherapy at least 4 weeks and up to 12 weeks prior to randomization and must be adequately recovered from chemotherapy therapy. For patients in the adjuvant setting, neoadjuvant chemotherapy or chemoradiotherapy is acceptable provided that patients also received adjuvant chemotherapy as per protocol's requirement Participants with Stage IV NSCLC •Histologically or cytologically confirmed, Stage IV non-squamous or squamous NSCLC •Life expectancy >=18 weeks in the opinion of the investigator •PD-L1 expression >=50% as documented through local or central testing of a representative tumor tissue specimen •No prior systemic treatment for Stage IV non-squamous or squamous NSCLC •Participants who have received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment-free interval of at least 6 months from randomization since the last chemotherapy, radiotherapy, or chemoradiotherapy cycle 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 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 105
Exclusion criteria
Exclusion criteria: •History of malignancy within 5 years prior to initiation of study treatment •Uncontrolled tumor-related pain •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage •Participants known to have a sensitizing mutation in the EGFR gene or an ALK fusion oncogene •History of leptomeningeal disease •Uncontrolled or symptomatic hypercalcemia •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 on screening chest computed tomography (CT) scan •Active tuberculosis •Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina •Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study •Severe infection within 4 weeks prior to initiation of study treatment •Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment •Prior allogeneic stem cell or solid organ transplantation •Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the participant at high risk from treatment complications •Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab •Current treatment with anti-viral therapy for hepatitis B virus (HBV) •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– programmed cell death protein 1 (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 •History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins •Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation •Pregnant or breastfeeding, or intention of becoming pregnant during study treatment or 5 months after the final dose of study treatment •Known allergy or hypersensitivity to hyaluronidase, bee or vespid venom, or any other ingredient in the formulation of rHuPH20 •Pathology that could interfere with any protocol-specified outcome assessment •Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >=2 weeks prior to randomization Participants with Stage IV NSCLC •Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To evaluate participant preference for atezolizumab subcutaneous (SC) compared with atezolizumab intravenous (IV) ;Secondary Objective: •To evaluate participant-reported satisfaction with atezolizumab SC and atezolizumab IV •To evaluate participants’ choice of atezolizumab SC for the Treatment Continuation Period •To evaluate healthcare professionals (HCP) perception of time/resource use and convenience for administration with atezolizumab SC and IV •To evaluate health-related quality of life (HRQoL) with atezolizumab SC and atezolizumab IV •To monitor the ongoing clinical benefit of atezolizumab •To evaluate the overall safety and tolerability of atezolizumab SC and atezolizumab IV •To evaluate the safety of switching from atezolizumab SC to atezolizumab IV and from atezolizumab IV to atezolizumab SC ;Primary end point(s): 1.Proportion of participants who preferred atezolizumab SC to atezolizumab IV;Timepoint(s) of evaluation of this end point: Up to approximately 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Participant-reported satisfaction with atezolizumab SC and atezolizumab IV 2.Proportion of participants who select atezolizumab SC for the Treatment Continuation Period 3.HCP perception of time/resource use and convenience for administration with atezolizumab SC and 4.Change in symptoms and function from baseline and over time as assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) scores, and mean and mean changes from baseline score in HRQoL by cycle as assessed by the Global Health Status/Quality of Life (GHS/QoL) scale of the EORTC QLQ-C30 5.Percentage of participants with continuing clinical benefit after 16 cycles of atezolizumab, as assessed by the investigator according to local standard of care 6.Incidence, severity, and nature of adverse events, with severity determined according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0) 7.Incidence, severity, and nature of adverse events, with severity determined according to NCI CTCAE v5.0 during the study Treatment Cross-over Period by treatment arm;Timepoint(s) of evaluation of this end point: 1-7.Up to approximately 2 years | — |
Countries
Argentina, Brazil, Canada, Chile, Costa Rica, Finland, Hungary, Italy, Korea, Democratic People's Republic of, Korea, Republic of, Latvia, Poland, Russian Federation, Spain, Ukraine, United States
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffmann-La Roche Ltd
Outcome results
None listed