This trial is being carried out to examine the effectiveness of a new immune therapy, zimberelimab, alone or in combination with other immune therapies (domvanalimab and etrumadenant) in patients with PD-L1 positive non-small cell lung cancer (NSCLC). The main outcomes to be measured in this trial is the response rate and survival without disease progression.
The details
NSCLC is responsible for 85% of all lung cancer diagnoses worldwide. PD-L1 is a protein found in immune cells that can be present in high levels in cancer cells. Zimberelimab (AB122) is an immune drug that binds PD-L1 and reduces its activity. This improves the anti-cancer activity of the immune cells. Domvanalimab (AB154) is an immune therapy that blocks abnormal cancerous cell activity. Etrumadenant (AB928) is an immune drug that can be combined with chemotherapy to reduce cancer cell activity.
This trial will evaluate the effectiveness of zimberelimab alone or in combination with domvanalimab and with domvanalimab and etrumadenant in patients with NSCLC. The main outcomes to be measured are the response rate and survival without disease progression.
Who are they looking for?
This trial is looking to recruit 150 patients with confirmed NSCLC. Patients must have measurable disease and have adequate organ and bone marrow function.
Patients will be excluded from this trial if they have had a live vaccine within 28-days of the first dose of the new drug. Patients treated with steroids or with immunosuppressive medications, those with hepatitis B, C, or HIV, a history of autoimmune disease, or patients who have had a malignancy within the previous two years will also be excluded.
How will it work
There will be three groups in this study. Group 1 will receive zimberelimab alone. Group 2 will receive zimberelimab and domvanalimab. Group 3 will receive zimberelimab, domvanalimab, and etrumadenant. All drugs will be given as an intravenous (IV) infusion.
The response rate and survival without cancer progression are the main outcomes that will be measured over the course of this trial. Patients will be followed up for approximately 3-5 years.
