This phase 2 trial will investigate the safety and effectiveness of durvalumab (Imfinzi) in patients with stage III non-small cell lung cancer (NSCLC).
The main outcomes will be the number of treatment-related adverse events (TRAEs) and progression-free survival (PFS).
The details
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. It is often diagnosed at an advanced stage. In some cases, the tumor may not be operable (unresectable). Platinum-based chemotherapy (PBCT) may be used to shrink the tumor. Additional medication could be used to reduce the recurrence of cancer. Durvalumab (DVB) is an immune checkpoint inhibitor (ICI). ICI drugs are a new type of cancer treatment. They help the immune system to recognize and kill cancer cells.
This trial will investigate the safety and effectiveness of DVB in patients with unresectable NSCLC. The main outcomes will be the number of TRAEs and PFS.
This trial is recruiting at a number of locations in the US.
Who are they looking for?
This study will recruit 150 patients with stage 3 NSCLC. There must be no evidence of cancer progression after PBCT. Patients must have a life expectancy of greater than 12 weeks. Patients must have adequate bone marrow and organ function and female patients should not be pregnant.
Patients cannot take part in the trial if they have any autoimmune or inflammatory conditions or if they have had an organ transplant from a donor. Other exclusion criteria include active infection, cardiac or lung symptoms, gastrointestinal conditions or other cancers. Patients cannot have been previously exposed to other ICI drugs. Pregnant or breastfeeding women cannot take part in the trial.
How will it work
Patients will be separated into two groups based on performance score, 0-1 and 2. All participants will receive DVB (1500 mg) once every 4 weeks. This will be delivered using an intravenous infusion. Treatment will continue for up to 24 months.
The main outcomes will be the number of serious TRAEs and PFS.
