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This is a single-arm phase II trial to evaluate the efficacy and safety of atezolizumab and bevacizumab combination therapy (stage 2) after radiologic progression of atezolizumab monotherapy (stage 1) in Korean patients with locally advanced or metastatic NSCLC who have progressed during or following a platinum-containing regimen. Initially, patients will be treated with Atezolizumab 1200mg every 3 weeks as a single agent (stage 1). After radiologic progression from atezolizumab monotherapy, patients will be consequently treated with atezolizumab (1200mg every 3 weeks) and combination with bevacizumab (15mg/kg every 3 weeks). Exploratory biomarkers will be observed in order to identify predictive biomarkers correlated to response and to evaluate the changes of local and systemic immune profile between baseline and at the time of progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atezolizumab | Experimental | The dose level of atezolizumab proposed to be tested in this study is 1200 mg administered by IV infusion every 3 weeks (q3w) |
|
| Atezolimab+Bevacizumab | Experimental | Once radiologic progression confirmed from atezolizumab monotherapy (stage 1), 1200mg of atezolizumab would be administered with 15mg/kg of bevacizumab as combination therapy (stage 2). Both of drugs are administered via intravenous infusion every 3 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab | Drug | Stage I: The dose level of atezolizumab proposed to be tested in this study is 1200 mg administered by IV infusion every 3 weeks (q3w) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective for this study is to evaluate efficacy of atezolizumab with bevacizumab after radiologically progress of atezolizumab monotherapy | measured by disease control rate (DCR) per investigator using RECIST v1.1 | about 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Best overall response rate | Best overall response rate | about 36 months |
| Progression-free survival | PFS, defined as the time from the first administration of atezolizumab and bevacizumab to the first occurrence of disease progression as determined by investigator using RECIST v1.1 or death from any cause, whichever comes first |
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Inclusion Criteria:
Patients must meet all of the following criteria to be eligible for study entry:
Exclusion Criteria:
Patients who meet any of the following criteria will be excluded from study entry.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Myung-Ju Ahn, PhD | Contact | 82-2-3410-3438 | silk.ahn@samsung.com | |
| hyunjung Shin | Contact | 82-70-7014-6763 | hjds.shin@samsung.com |
| Name | Affiliation | Role |
|---|---|---|
| Myung-Ju Ahn, PhD | Samsung Medical Center | Principal Investigator |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Bevacizumab | Drug | Stage II: Once radiologic progression confirmed from atezolizumab monotherapy (stage 1), 1200mg of atezolizumab would be administered with 15mg/kg of bevacizumab as combination therapy every 3 weeks. |
|
|
| about 36 months |
| Duration of response | DOR, defined as the time from first occurrence of a documented objective response to the time of disease progression as determined by the investigator using RECIST v1.1 or death from any cause, whichever comes first | about 36 months |
| Overall survival | OS, defined as the time from the first administration of atezolizumab and bevacizumab to death from any cause | about 36 months |
| Adverse events (AEs) | Adverse events will be measured by the CTCAE scale, version 4.0 | about 36 months |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |