Previously untreated Stage IV, Squamous, Non-Small Cell Lung Cancer (NSCLC) MedDRA version: 19.0 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
Interventions
Product Name: Atezolizumab (MPDL3280A-RO5541267)
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Not Yet defined
Current Sponsor code: R
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •ECOG performance status of 0 or 1 •Histologically or cytologically confirmed, Stage IV squamous NSCLC •Tumor PD-L1 expression as determined by an IHC assay performed by a central laboratory on previously obtained archival tumor tissue or tissue obtained from a biopsy at screening •Measurable disease, as defined by RECIST v1.1 •Adequate hematologic and end-organ function •Patient with a history of treated asymptomatic CNS metastases are eligible, provided they meet all of the following criteria: Measurable disease outside CNS Only supratentorial metastases allowed (i.e., no metastases to midbrain, pons, medulla or spinal cord) No ongoing requirement for corticosteroids as therapy for CNS disease; anticonvulsants at a stable dose allowed No stereotactic radiation within 7 days or whole-brain radiation within 14 days prior to randomization No evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study •Patients with new asymptomatic CNS metastases detected at the screening scan must receive radiation therapy and/or surgery for CNS metastases. Following treatment, these patients may then be eligible without the need for an additional brain scan prior to enrollment, if all other criteria are met. •Women who are not postmenopausal (12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of study drug. 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 7 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: •Active or untreated CNS metastases •Leptomeningeal disease •Uncontrolled tumor-related pain •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures •Uncontrolled or symptomatic hypercalcemia •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 severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins •Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation •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 •Positive test for HIV •Patients with active hepatitis B or hepatitis C •Active tuberculosis •Severe infections within 4 weeks prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia •Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 3 months prior to randomization, unstable arrhythmias, or unstable angina •Administration of a live, attenuated vaccine within 4 weeks before randomization, during treatment, or within 90 days following last dose of atezolizumab (for patients randomized to atezolizumab) •Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The study is currently closed to enrollment due to a low number of patients; therefore, the outcome measures of this study are no longer applicable and formal analyses of efficacy or safety will not be performed;Primary end point(s): The study is currently closed to enrollment due to a low number of patients; therefore, the outcome measures of this study are no longer applicable and formal analyses of efficacy or safety will not be performed;Timepoint(s) of evaluation of this end point: Not applicable;Main Objective: The study is currently closed to enrollment due to a low number of patients; therefore, the outcome measures of this study are no longer applicable and formal analyses of efficacy or safety will not be performed | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The study is currently closed to enrollment due to a low number of patients; therefore, the outcome measures of this study are no longer applicable and formal analyses of efficacy or safety will not be performed;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Czech Republic, France, Germany, Greece, Hungary, Italy, Korea, Republic of, Poland, Romania, Spain, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
F.Hoffmann-La Roche Ltd
Outcome results
None listed