This trial is looking to compare the effectiveness of local therapy (surgery or radiotherapy) plus ipilimumab (Yervoy) and nivolumab (Opdivo) to ipilimumab and nivolumab alone in patients with metastatic (has spread) non-small cell lung cancer (NSCLC). The main outcome that will be measured is overall survival. This study is being conducted in Texas, USA.
The details
Local therapy such as radiation and surgery are common in treating many types of cancer. Ipilimumab and nivolumab are immunotherapies for metastatic tumors (cancer that has spread). They use the body’s own immune system to identify and kill cancer cells throughout the body. Both drugs work by inhibiting proteins on immune cells that normally dampen immune responses.
This study wants to know if adding local therapy (surgery and/or radiation therapy) to ipilimumab and nivolumab is more effective than immunotherapy alone. The main outcome measured will be overall survival.
Who are they looking for?
The study is looking to recruit 270 patients with stage 4 NSCLC. Patients may have had one prior treatment with chemotherapy. Women of childbearing age must be using contraception, and must not be pregnant or breastfeeding. Men who are sexually active with women of childbearing age must also use contraception. Subjects who have brain metastases are able to be in the study as long as the disease has not progressed for 4 weeks. There must be a 28 day period after treatment for brain metastases before this trial can start. Subjects may have received radiotherapy before on spread tumors, as long as there is at least one tumor that has not had radiation therapy performed on it.
Patients are not able to participate in the study if they have had any anti-cancer medication in the last 3 weeks. Patients who have any diseases requiring treatment with corticosteroids or other medications which target the immune system cannot be included. Patients with any prior cancer that has been active in the last 2 years, hepatitis, HIV, a history of allergies to the drugs in the study or liver problems are excluded from the study.
How will it work
Patients will be split into two groups. The first group will receive treatment with ipilimumab and nivolumab during six-week cycles. This treatment will be administered for up to two years, or until cancer progresses (tumor grows). The second group will recieve two 6-week cycles of ipilimumab and nivolumab. Within 14 days the last dose of nivolumab, group 2 will recieve local therapy (surgery and/or radiotherapy). Survival rates or cancer growth will be monitored up to 2 years.
