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| Name | Class |
|---|---|
| parkview cancer institute | UNKNOWN |
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The purpose of this study is to see if adding pirfenidone to atezolizumab will increase anti tumor activity and reduce treatment resistance in stage 4 and recurrent non- small cell lung cancer participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Atezolizumab (Tecentriq) intravenous (IV) 1200mg flat dose day 1 then every 3 weeks. Pirfenidone (Esbriet) orally (PO) with food according to this schedule: Days 1-14: 267 milligrams (mg) orally three times per day (PO TID) Days 15-29: 534 mg PO TID Days 30 onward until progression: 801 mg PO TID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab is given as an intravenous infusion at 1200 mg every 3 weeks. Pirfenidone is taken by mouth 3 times a day with the dose increasing every 2 week until day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Grade 3 toxicity | CTCAE v5.0 | Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days) |
| Occurrence of Grade 4 toxicity | CTCAE v5.0 | Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) of participants | RECIST 1.1 | Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days) |
| Progression Free Survival (PFS) | RECIST 1.1 |
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Inclusion Criteria:
Exclusion Criteria:
Unstable angina Myocardial infarction within 6 months Uncontrolled congestive heart failure Left ventricular ejection fraction < 35%
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| KUCC Navigator | Contact | 9135883671 | KUCC_Navigation@kumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Chao Huang, MD | The University of Kansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Kansas Cancer Center (KUCC) | Not yet recruiting | Fairway | Kansas | 66205 | United States |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| C093844 | pirfenidone |
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|
| From Cycle 1 day 1 (Each cycle is 21 days) for up to 2 years after end of treatment |
| 1-year overall survival (OS) rate: Proportion of participants alive at 1 year from Cycle 1 day 1 | Medical records | Cycle 1 day 1 up to 1 year post-Cycle 1 day 1 (Each cycle is 21 days) |
| The University of Kansas Cancer Center, Westwood Campus | Recruiting | Kansas City | Kansas | 66205 | United States |
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |