Study on the Effectiveness and Safety of Zimberelimab and Domvanalimab for Lung Cancer
Sponsor: Arcus Biosciences, Inc.
Sponsor score: 0
ClinicalTrials ID:NCT04736173
This phase 2 clinical trial is testing a combination of two drugs, zimberelimab and domvanalimab, to see if they are effective and safe for treating patients with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) that shows high levels of a protein called PD-L1.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to evaluate how well the combination of zimberelimab and domvanalimab works in treating patients with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) that has high PD-L1 expression. The study will also assess the safety of this treatment approach.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) with high PD-L1 expression.
- Have not received prior treatment for this cancer.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have at least one tumor that can be measured by standard criteria.
- Have adequate organ and bone marrow function.
- If there are brain or meningeal metastases, they must be stable, with no new symptoms or growth for at least 4 weeks before starting the study treatment. Participants must not need corticosteroids for brain metastases for at least 14 days before starting treatment. Those who had brain metastases treated with surgery or radiation may join if treatment ended at least 4 weeks (or 2 weeks for stereotactic radiation) before starting the study treatment.
- Cannot have carcinomatous meningitis.
Exclusion Criteria
- Have a tumor with a genetic change that can be treated with an approved targeted therapy.
- Have received any live vaccines within 28 days before starting the study treatment.
- Have an active autoimmune disease or a history of autoimmune disease that required treatment in the past 2 years, except for vitiligo or resolved childhood asthma/allergies.
- Have had another active cancer within the past 2 years, except for certain skin cancers or other localized cancers that have been treated and cured.
- Have previously been treated with any drugs targeting PD-1, PD-L1, or other immune checkpoints.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| John B. Amos Cancer Center | 31904 | Columbus | Georgia |
| Lumi Cancer Institute | 77339 | Kingwood | Texas |
| Oncology and Hematology Associates of Southwest Virginia, Inc. | 24014 | Blacksburg | Virginia |
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