This trial aims to evaluate the safety and effectiveness of the combination of nivolumab (Opdivo), ipilimumab (Yervoy), and paclitaxel (Taxol) for treating lung cancer.
The main outcome that will be measured is survival without the tumor growing or spreading. The study is taking place in Durham, North Carolina, the United States.
The details
Nivolumab, ipilimumab, and paclitaxel are common medications used to treat cancer. However, these medications have not been used together before. It is not known if using these three treatments together will be safe, or will cause any side effects.
This trial aims to evaluate the safety and effectiveness of the combination of nivolumab, ipilimumab, and paclitaxel for the treatment of patients with previously untreated non small cell lung cancer (NSCLC). The main outcome that will be measured is how long it takes from the time the patient starts taking the drug to when the tumor starts to grow again.
Who are they looking for?
This trial is recruiting 49 patients with NSCLC. Patients are allowed to have had chemotherapy before, as long as it was six months or more since it finished. Patients must not be pregnant, breastfeeding, or planning to get pregnant soon. Patients of childbearing age must use contraceptive methods during the study and up to 90 days after the last dose. Patients must have adequate kidney, liver and blood function.
Patients will not be allowed in the trial if they have any infections like HIV or hepatitis. Patients cannot have an autoimmune condition. Patients cannot have a brain or spinal column tumor that is active. Patients must not have a history of heart problems.
How will it work
This trial will consist of one group. Everyone will receive the same treatment. Patients will receive treatment with nivolumab every 3 weeks, ipilimumab every 6 weeks, and paclitaxel on days 1 and 8 every 21 days. The treatment may last for up to 48 months.
Patients will be followed up to 5 years. The outcomes measured will be survival without cancer growing or spreading, the overall response to treatment and side effects to the treatment.
