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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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This is a research study to evaluate the safety and effectiveness of tocilizumab in combination with atezolizumab to treat non-small cell lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atezolizumab and Tocilizumab | Experimental | Participants receive Atezolizumab 1200mg IV and Tocilizumab 6mg/kg IV (or Tocilizumab 4mg/kg IV) every 21 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab | Drug | 1200mg infusion |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | Assess the proportion of patients with a radiologic response by RECIST 1.1 at 12 weeks. | From first dose of protocol treatment until radiologic disease assessment at 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Estimate the time from first dose of protocol treatment until death due to any cause or last patient contact alive until 3 months after study closure | From first dose of protocol treatment until death due to any cause or last patient contact alive until 3 months after study closure. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcomes | Correlate clinical outcomes with potential markers of immune escape and changes in the tumor microenvironment and blood using a novel field theory based methods under development by Cold Spring Harbor Laboratory. | From enrollment until dealth due to any cause or last patient contact alive until 3 months after study closure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melissa Volpe, BA | Contact | 215-220-9703 | melissa.volpe@pennmedicine.upenn.edu | |
| Melina Marmarelis, MD, MSCE | Contact | 215-615-5835 | melina.marmarelis@pennmedicine.upenn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Melina Marmarelis, MD, MSCE | Abramson Cancer Center at Penn Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center of the University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Tocilizumab | Drug | Tocilizumab 6mg/kg or 4mg/kg infusion |
|
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| Dose Limiting Toxicities of the combination |
Determine dose limiting toxicities of the combination |
| From first dose of protocol treatment until 49 days post treatment |
| Progression free survival (PFS). | Estimate the time from first dose of protocol treatment until first radiologic disease progression, unequivocal clinical progression, or death due to any cause censored at the last scheduled disease assessment on study if there is no progression date registered. | From 1st dose of treatment until 1st radiologic disease progression, unequivocal clinical progression, or death due to any cause censored at the last scheduled disease assessment on study if no progression date registered, assessed up to 24 months. |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| C502936 | tocilizumab |
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