This phase 3 trial will investigate the safety and effectiveness of pembrolizumab (Keytruda) and chemotherapy with or without canakinumab (Ilaris) in non-small cell lung cancer (NSCLC). The main outcomes will be side effects and survival rates.
The details
Non-small cell lung cancer (NSCLC) is the most common form of lung cancer. Platinum-based chemotherapy is a standard treatment for NSCLC. In advanced disease, this treatment is less effective. Combining platinum-based chemotherapy with new targeted therapies may improve survival rates.
Canakinumab is a drug that blocks an immune factor called interleukin-1β (IL-1β). Some studies suggest this drug can improve lung cancer progression. Pembrolizumab is an immune-checkpoint inhibitor (ICI) drug. ICIs are a new type of drug that helps target cancer with less toxic effects. Pembrolizumab allows the immune system to recognize cancer cells and kill them.
This trial will investigate the safety and effectiveness of pembrolizumab and platinum-based chemotherapy with or without canakinumab in NSCLC. The main outcomes will be side effects and survival rates.
Who are they looking for?
This trial will recruit 627 patients with NSCLC. ?Patients cannot take part in the trial if they have been treated with an ICI previously. Patients with a compromised immune system cannot take part. Other exclusion criteria include recent vaccination, brain tumors, or active infections.
How will it work
There are two phases to this trial. Initially, all patients will receive pembrolizumab, canakinumab, and 2 platinum-based chemotherapy drugs. During this phase, the safety of the treatment will be monitored.
In the second phase, patients will be assigned to one of two groups. One group will continue pembrolizumab with platinum-based chemotherapy, and canakinumab treatment. A second group will be treated with pembrolizumab, platinum-based chemotherapy, and a placebo. The trial will last up to 38 months. Progression-free survival,overall survival, and side effects will be assessed.
