This trial is examining the effectiveness of pegilodecakin (AM0010) when it is used with pembrolizumab (Keytruda) to treat patients with advanced non-small cell lung cancer (NSCLC). The main outcome to be measured will be tumor responses to the treatment. This trial is recruiting in multiple locations around the United States.
NSCLC is one of the most common types of lung cancer. Biological therapies such as pembrolizumab, which kill cancer cells with PD-L1, have improved treatment for patients. However, they are not completely effective for all patients. Pegilodecakin is a new drug which may boost the effects of pembrolizumab.
This trial aims to compare how effective pegilodecakin and pembrolizumab combined are compared to pembrolizumab alone. The main outcome to be measured will be the overall response.
Who are they looking for?
This trial is looking for 100 patients with advanced NSCLC that are aged 18 or over. Patients should have high amounts of PD-L1 on tumors. Patients that have had radiotherapy at least 2 weeks before the trial starts can participate. Patients who have not had treatment for advanced cancer can participate. Patients who previously received treatment after surgery can participate if the treatment was more than 12 months before the trial starts.
Patients who have cancer in the brain or spine cannot participate. Patients with another serious medical condition cannot participate. Patients with infections such as HIV or hepatitis cannot participate. Patients who experienced side effects of previous treatment cannot participate. Patients who received pembrolizumab or certain biological therapies before cannot participate. Female patients who are pregnant or breast-feeding cannot participate. Patients participating in another clinical trial within 28 days before this trial starts also cannot participate.
How will it work
Patients will be divided into 2 groups. The first group will receive pegilodecakin and pembrolizumab. The second group will receive pembrolizumab alone.
Tumor responses to treatment will be measured for 36 months. Survival of patients and survival without the cancer worsening will also be measured for 36 months.