This multicenter phase 3 clinical trial will test the effectiveness of nivolumab (Opdivo) after surgery and chemotherapy in stage 1b to 3a non-small cell lung cancer (NSCLC). The primary outcome will be measured by the length of time the patient survives without signs of the cancer and the overall survival rate for up to 10 years.
The details
In stage 1b to 3a NSCLC the cancer begins to spread to surrounding tissue (1b) and eventually invades the lymph nodes on the side of the chest where the cancer started (3a). Surgery and chemotherapy are common treatments for these stages of NSCLC. Nivolumab is an immunotherapy drug to treat cancer that has spread. It uses the body’s own immune system to identify and kill cancer cells throughout the body. The drug works by inhibiting proteins on immune cells that normally reduce immune responses.
The study will determine the effectiveness of nivolumab following surgery and chemotherapy in patients with NSCLC. The study will examine the time the patient survives with no signs of cancer (even in the opposite lung), the survival rate, and any side effects over the course of 10 years.
Who are they looking for?
This trial is recruiting 714 patients with 1b, 2, or 3a NSCLC who have undergone complete surgical resection (removal of the tumor) and completed chemotherapy. Patients with non-squamous tumors must not have mutations in the EGFR or ALK genes. Patients should have normal or near normal laboratory values.
Participants cannot have received any prior treatments with an immune checkpoint inhibitor, undergone surgery within 4 weeks prior to enrollment or received chemotherapy within 2 weeks prior to enrollment. Patients cannot have autoimmune diseases, lung diseases, uncontrolled illness, HIV, hepatitis B, or hepatitis C. Women cannot be pregnant or breastfeeding, and must agree to use contraception.
How will it work
Patients will be randomly divided into two groups. One group will receive nivolumab intravenously (through IV into a vein) over 30 minutes on day 1 of a 2 week cycle for up to 1 year in the absence of disease progression or side effects. The other group will not receive any treatment and will be followed with imaging.
