This phase III trial aims to determine whether nivolumab (Opdivo) is effective at treating recurrent stage IV squamous cell lung cancer alone or in combination with ipilimumab (Yervoy). The main outcomes of the trial will be overall survival (time from beginning trial until death), progression free survival (time from beginning trial until disease progression) and toxic side effects.
The details
Nivolumab and ipilimumab are both anti-cancer drugs that work to activate the immune system. Currently, the drugs are used together to treat certain types of cancer after a first line of treatment has failed. It is unknown whether nivolumab is more effective with or without ipilimumab in patients with squamous cell lung cancer.
This trial will determine the effectiveness of these drugs in combination or alone in terms of overall survival, progression free survival, side effects, and response rate (amount of patients with tumor size reduction).
Who are they looking for?
This trial takes place in the United States and Canada and is recruiting 350 patients with stage IV squamous cell lung cancer that has recurred after previous treatment. Previous treatment with cancer immunotherapy is not accepted, nor is treatment with corticosteroids or immunosuppressive medicines less than 14 days before beginning the trial. Patients must not have any autoimmune diseases, active infections including hepatitis or HIV, or allergies to any components of the trial drugs.
How will it work
Patients will be randomly assigned to one of two groups. 1 group of patients will be treated with nivolumab intravenously once every 14 days. Every 42 days, patients will be treated with ipilimumab intravenously. The other group of patients will be treated with nivolumab intravenously every 14 days. After treatment, patients will be followed for 3 years.
