This phase 3 trial will investigate the effectiveness of cemiplimab (Libtayo) and ipilimumab (Yervoy) in combination with platinum-based chemotherapy in patients with advanced non-small cell lung cancer (NSCLC). The main outcome will be response to treatment and survival without cancer growing or spreading.
The details
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. Conventional treatment for advanced disease involves chemotherapy. In many cases, chemotherapy used is platinum-based. This is only partially effective in advanced NSCLC. New target therapy drugs may improve treatment. These target certain proteins involved in cancer growth. Cemiplimab and ipilimumab are targeted therapies.
This trial will investigate the effectiveness of cemiplimab and ipilimumab in combination with platinum-based chemotherapy. The main outcome will be response to treatment and survival without cancer worsening.
Who are they looking for?
This trial will recruit 690 patients with NSCLC. Patients must have a tumor biopsy sample and must have a life expectancy of greater than 3 months.
Patients cannot take part in the trial if they do not have a history of smoking. Metastases to the brain or spine are excluded also. Other exclusion criteria include a history of brain inflammation, uncontrolled seizures, lung disease, autoimmune disease or steroid treatment.
How will it work
Patients will be randomly assigned to one of three groups. One group will undergo platinum-based chemotherapy. Another group will undergo platinum-based chemotherapy and cemiplimab. The third group will be treated with platinum-based chemotherapy, cemiplimab, and ipilimumab.
Patients will be monitored during the trial for side effects, response to treatment and survival. The trial will last up to 32 months.
