Malignant neoplasm of bronchus and lung (nsc) adv. MedDRA version: 20.0 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. Hoffman-La Roche Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Signed Informed Consent Form - Age = 18 years - Able to comply with the study protocol, in the investigator's judgment - Histologically or cytologically documented Stage IIIb or Stage IV NSCLC that has progressed following standard systemic chemotherapy (including if given in combination with anti-PD-1 therapy after anti-PD-1 as monotherapy, or after TKI therapy). Patients with a previously detected sensitizing EGFR mutation or ALK fusion oncogene must have received targeted therapy(TKI), followed by at least one line of standard systemic chemotherapy, prior to receiving atezolizumab. Overall, patients should not have received more than two lines of standard systemic chemotherapy. Patients who have discontinued first-line or second-line therapy due to intolerance are also eligible. –Staging must be according to the UICC/AJCC system, 7th edition (Detterbeck et al. 2009) (see Appendix 8) –Pathological characterization may be conducted on tumor specimens from earlier stage disease, but the tumor samples must be sufficient to distinguish squamous or non-squamous histology–Chemotherapy regimens will be counted based on interval disease progression, and not on the number of agents or the number of switches in agents (e.g., a first-line or second-line therapy that consists of several cycles of a platinum doublet and subsequent maintenance therapy that introduces or switches to a new chemotherapy agent without interval disease progression will all be considered one chemotherapy regimen) –Patients with a previously-detected sensitizing EGFR mutation must have experienced disease progression (during or after treatment) on an EGFR TKI (erlotinib, gefitinib, osimertinib, etc.) –Patients with a previously detected ALK fusion oncogene must have experienced disease progression (during or after treatment) with crizotinib, alectinib, or another ALK inhibitor –Prior radiation therapy is allowed, provided that the patient has recovered from any toxic effects thereof. Combined radiation/chemotherapy treatment constitutes a single regimen –Combined radiation/chemotherapy treatment (chemoradiation) counts as one prior chemotherapy regimen if < 6 months have elapsed between the last dose and the date of recurrence –Adjuvant/neoadjuvant chemotherapy is not counted as a line of treatment –Debulking surgery and anticancer agents used for pleurodesis are not counted as lines of therapy - The last dose of prior systemic anticancer therapy or targeted therapy must have been administered = 21 days prior to randomization. - Measurable disease, as defined by Response Evaluation Criteria for Solid Tumors, Version 1.1 (RECIST v1.1) - Patients with asymptomatic CNS metastases (treated or untreated), as determined by CT or MRI evaluation during screening and prior radiographic evaluation, are eligible - ECOG performance status 0, 1, or 2 [Appendix 7] - For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab –A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (= 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus) –Examples of contraceptive methods with a failure rat
Exclusion criteria
Exclusion criteria: - Symptomatic CNS metastases - 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 - Leptomeningeal disease - Uncontrolled pericardial effusion or ascites requiring recurrent drainage procedures - Pregnant or lactating, or intending to become pregnant during the study –Women who are not postmenopausal (postmenopausal defined as = 12 months of non-drug-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 2 weeks prior to initiation of study drug - Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol, including significant liver disease (such as cirrhosis, uncontrolled major seizure disorder, or superior vena cava syndrome) - Significant cardiovascular disease, such as New York Heart Association cardiac disease = Class III, myocardial infarction within 3 months, unstable arrhythmias, or unstable angina –Patients with known coronary artery disease or left ventricular ejection fraction 8 weeks –Patients with a history of serious or life threatening immune-related events –No more than 1 concomitant autoimmune disease at the time of study entry is allowed unless one of them is: Autoimmune-mediated hypothyroidism on a stable dose of thyroid replacement hormone Controlled Type I diabetes mellitus on a stable dose of insulin regimen A medical history of such entities as atopic disease or childhood arthralgias, where the clinical suspicion of autoimmune disease is low. In addition, transient autoimmune manifestations of an acute infectious disease that resolved upon treatment of the infectious agent are not excluded (e.g., acute Lyme arthritis) - Treatment with systemic immunostimulatory agents (including, but not limited to, interferons or interleukin-2) within 4 weeks or five half-lives of the drug, whichever is longer, prior to initiation of study treatment –Prior cancer vaccines and cellular immunotherapy are permitted - Specifically for patients without autoimmune disease: treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents) within 2 weeks prior to study treatment initiation, or anticipated requirement for systemic immunosuppressive medications during the trial –For patients with CNS metastases, use of prednisone at a stable dose (or dose equivalent) of = 20 mg/day is acceptable –Chronic use of prednisone or equivalent should be discussed with the Medical Monitor –The use of inhaled corticosteroids for chronic obstructive pulmonary disease,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -To evaluate the long-term safety of atezolizumab in previously treated patients with advanced NSCLC;Secondary Objective: - To evaluate the efficacy of atezolizumab in previously treated patients with advanced NSCLC - To further evaluate the efficacy of atezolizumab in previously treated patients with advanced NSCLC - To further evaluate the long-term safety and efficacy of atezolizumab in previously treated patients with advanced NSCLC;Primary end point(s): •Incidence of serious adverse events (SAEs) related to atezolizumab treatment •Incidence of immune-related adverse events (irAEs) related to atezolizumab treatment. ;Timepoint(s) of evaluation of this end point: At the end of the study. The end of study and final analysis will occur when all enrolled patients have either died, withdrawn consent, are lost to follow up, or have been followed for 30 months since the last study patient is enrolled, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Overall survival (OS) rate at 2 years, defined as the proportion of patients remaining alive 2 years after initiation of study treatment • OS, defined as the time from initiation of study treatment to death from any cause • Progression-free survival (PFS), defined as the time from initiation of study treatment to the first occurrence of disease progression or death from any cause, whichever occurs first. PFS will be calculated based on disease status evaluated by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) and also by disease status evaluated by the investigator according to modified RECIST • OS rate at 3 years, defined as the proportion of patients remaining alive 3 years after initiation of study treatment • Objective response rate (ORR), defined as the percentage of patients who attain complete response (CR) or partial response (PR) according to RECIST v1.1 and also by disease status evaluated by the investigator according to modified RECIST • Duration of response (DOR), defined as the time from initial response to disease progression or death among patients who have experienced a CR or PR (unconfirmed) during the study. Duration of response will be calculated based on disease status evaluated by the investigator according to RECIST v1.1 and also by disease status evaluated by the investigator according to modified RECIST ;Timepoint(s) of evaluation of this end point: At the end of the study. The end of study and final analysis will occur when all enrolled patients have either died, withdrawn consent, are lost to follow up, or have been followed for 30 months since the last study patient is enrolled, whichever occurs first. | — |
Countries
Algeria, Argentina, Brazil, China, Colombia, Costa Rica, Denmark, Greece, Guatemala, Italy, Latvia, Lebanon, Malaysia, Mexico, Morocco, Netherlands, Panama, Peru, Philippines, Poland, Slovenia, Spain, Sweden, United Arab Emirates, United Kingdom
Contacts
Public ContactTrial Information Support Line-TISL
F.Hoffmann-La Roche Ltd.
Outcome results
None listed