A PHASE III/IV, SINGLE ARM, MULTICENTER STUDY OF ATEZOLIZUMAB (TECENTRIQ) TO INVESTIGATE LONG-TERM SAFETY AND EFFICACY IN PREVIOUSLY-TREATED PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (TAIL)
- Conditions
- lungcancerNon-Small cell lung cancer10029107
- Registration Number
- NL-OMON44404
- Lead Sponsor
- Roche Nederland B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
-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 or after anti-PD-1 as monotherapy). Patients with a previously detected EGFR mutation or ALK fusion oncogene must have received targeted therapy followed by one line of standard systemic chemotherapy prior to receiving atezolizumab. Overall, patients should not have received more than two lines of systemic chemotherapy. Patients who have discontinued first-line or second-line systemic chemotherapy, targeted therapy, or anti-PD-1 therapy due to intolerance are also eligible;*Staging must be according to the UICC/AJCC system, 7th edition (Detterbeck et al. 2009);*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, 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. The only exceptions to this rule are TKIs that have been approved for treatment of NSCLC, which must have been discontinued * 7 days prior to Cycle 1, Day 1 (the baseline tumor scan must be obtained after discontinuation of prior TKIs; washout not required prior to obtaining the scan);- 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 reach
- 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 < 50% must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate;- Major surgical procedure within 4 weeks prior to study treatment initiation or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis;- History of autoimmune disease (Appendix 5) are allowed if controlled and on stable treatment (i.e., same treatment, same dose) for the last 12 weeks, with the exception of:;- Patients taking concurrent abatacept or belatacept treatment, unless therapy has been withdrawn for > 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 randomization, or anticipated requirement for systemic immunosuppressive medications during the trial;*For patients with CNS metastases, use of prednisone at a 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, mineralocorticoids (e.g., fludrocor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Incidence of serious adverse events (SAEs) related to atezolizumab treatment.<br /><br>Incidence of serious and non-serious immune-related adverse events (irAEs)<br /><br>related to atezolizumab treatment</p><br>
- Secondary Outcome Measures
Name Time Method <p>Overall survival (OS) rate at 2 years, defined as the proportion of patients<br /><br>remaining alive 2 years after initiation of study treatment</p><br>