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| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
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This is single arm, prospective, multi-center, cohort study to evaluate blood TMB for improved efficacy of atezolizumab in locally advanced or metastatic NSCLC at the study enrollment who failed one or more prior lines of chemotherapy including at least 1 platinum-based.
Atezolizumab is approved as the treatment of patients with locally advanced or metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy by the Ministry of Food and Drug Safety (MFDS) and the treatment is available on the National Health Insurance Service in South Korea. Patients will be treated with atezolizumab until loss of clinical benefit or unmanageable toxicity as routine practice.
In this study, the investigators will register patients who have a plan to be treated with atezolizumab as MFDS approval condition and meet study inclusion and exclusion criteria. The investigators will collect study related information during routine practice and collect blood and/or tissue(optional) samples to conduct the study.
Tumor assessment will be performed by investigator on the base of RECIST (version 1.1) and related information will be collected until disease progression for patients who have discontinued treatment. However, it will be collected until treatment discontinuation for patients who continue to receive atezolizumab following initial disease progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atezolizumab | Experimental | Atezolizumab 1200 mg will be administrated every 3 week cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab Injection [Tecentriq] | Drug | Blood sampling will be performed before and after 3rd cycle of atezolizumab for evaluation of tumor mutation burden |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | ORR between blood TMB-High vs. Low group | At the end of cycle 3 (each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | PFS in Intention-to-treat (ITT) population and subgroups according to blood TMB and programmed cell death-1 (PDL1) status | At the end of cycle 3 (each cycle is 21 days) |
| Safety profile |
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Inclusion Criteria:
Signed Informed Consent Form
Ability to comply with protocol
Aged ≥ 18 years
Histologically or cytologically confirmed NSCLC that is locally advanced or metastatic (i.e., Stage IIIB not eligible for definitive chemoradiotherapy, Stage IV, or recurrent) NSCLC at the study enrollment
Disease progression during or following treatment with a prior platinum-containing regimen for NSCLC
Measurable disease, as defined by RECIST v1.1 Measurable disease is defined by the presence of at least one measurable lesion by RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
Life expectancy ≥ 12 weeks
Adequate hematologic and end organ function:
Patients with documented liver metastases: AST and ALT ≤ 5 × ULN Patients with documented liver or bone metastases: alkaline phosphatase ≤ 5 × ULN
Exclusion Criteria:
Active or untreated central nervous system (CNS) metastases Patients with a history of treated CNS metastases that are asymptomatic are eligible
Malignancies other than NSCLC within 5 years prior to study enrollment, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated with curative intent, or ductal carcinoma in situ treated surgically with curative intent)
Pregnant and lactating women
• Women of childbearing potential should use effective contraception during treatment with atezolizumab and for at least 5 months following the last dose.
Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 3 months prior to study enrollment
Patients with autoimmune disorder or a history of chronic or recurrent autoimmune disorder
Uncontrolled idiopathic pulmonary fibrosis or drug-induced pneumonitis
Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to study enrollment
• Treatment with inhaled corticosteroid or megesterol acetate is permitted.
Patient with a known hypersensitivity to atezolizumab or any of the excipients
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| Name | Affiliation | Role |
|---|---|---|
| In-Jae Oh, MD, PhD | Chonnam National Univeristy Hwasun Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonnam National University Hwasun Hospital | Hwasun | Jeollanam-do | 58128 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30013197 | Result | Kim ST, Cristescu R, Bass AJ, Kim KM, Odegaard JI, Kim K, Liu XQ, Sher X, Jung H, Lee M, Lee S, Park SH, Park JO, Park YS, Lim HY, Lee H, Choi M, Talasaz A, Kang PS, Cheng J, Loboda A, Lee J, Kang WK. Comprehensive molecular characterization of clinical responses to PD-1 inhibition in metastatic gastric cancer. Nat Med. 2018 Sep;24(9):1449-1458. doi: 10.1038/s41591-018-0101-z. Epub 2018 Jul 16. | |
| 30082870 |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000594389 | atezolizumab |
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|
Incidence of Treatment-related Adverse Events as assessed by CTCAE version 4
| Through study completion, an average of 1 year |
| Result |
| Gandara DR, Paul SM, Kowanetz M, Schleifman E, Zou W, Li Y, Rittmeyer A, Fehrenbacher L, Otto G, Malboeuf C, Lieber DS, Lipson D, Silterra J, Amler L, Riehl T, Cummings CA, Hegde PS, Sandler A, Ballinger M, Fabrizio D, Mok T, Shames DS. Blood-based tumor mutational burden as a predictor of clinical benefit in non-small-cell lung cancer patients treated with atezolizumab. Nat Med. 2018 Sep;24(9):1441-1448. doi: 10.1038/s41591-018-0134-3. Epub 2018 Aug 6. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |