This trial aims to find out how well nivolumab (Opdivo) and temozolomide (Temodal) work in treating small-cell lung cancer that has come back, is resistant to treatment or has spread through the body. The main outcome that will be measured is how well the patients respond to the treatment. The study is taking place in the United States.
The details
Small-cell lung cancer can be difficult to treat. Nivolumab is a medication which may help the body’s immune system attack the cancer cells. Temozolomide is a chemotherapy drug that may help the action of nivolumab in killing cancer. These two drugs in combination have not been tested before in patients with small-cell lung cancer or neuroendocrine tumors.
This trial aims to find out how well nivolumab and temozolomide work in treating lung cancer that has come back, is resistant to treatment or has spread through the body. The main outcome that will be measured is how well the patients respond to the treatment.
Who are they looking for?
53 patients are needed for this trial. Patients must have adequate blood cell counts and liver and kidney function tests. Patients cannot be pregnant or breastfeeding, planning to get pregnant and should agree to use contraception during the study and up to 120 days after the study.
Patients cannot be in the trial if they have an infection, an autoimmune disease, another cancer or heart problems. Patients cannot be in another clinical trial, and cannot have received treatment with the study medications before. Patients will be excluded from the trial if they have previously been allergic to any of the study medication.
How will it work
This trial will consist of one group. They will all receive the same treatment. Patients will receive IV (into the vein) nivolumab and temozolomide for 28-day courses. The treatment will stop if the disease progresses or if there are serious side effects. Patients will be followed up for 3 years.
