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Home»Lung cancer» Looking for patients with stage 4 or recurrent non-small cell lung cancer to test the effectiveness of a combined immunotherapy with chemotherapy
Clinical Trial
Looking for patients with stage 4 or recurrent non-small cell lung cancer to test the effectiveness of a combined immunotherapy with chemotherapy
This phase 3 clinical trial will test the effectiveness of nivolumab (Opdivo), nivolumab with ipilimumab (Yervoy), or nivolumab with platinum-based chemotherapy compared with chemotherapy in treating patients with advanced non-small cell lung cancer (NSCLC). The primary outcome will be measured by the overall survival rate and time to disease progression.
The details
In advanced NSCLC, cancer has spread from its original location to other parts of the lungs or other parts of the body. Nivolumab and ipilimumab 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. Platinum-based chemotherapy is a treatment commonly used to treat lung cancer.
This trial will compare nivolumab, ipilimumab, and platinum chemotherapy in advanced NSCLC. The trial will examine the overall survival rate for 48 months and the time to disease progression for 40 months. The response rate and disease symptom improvement will also be measured over the course of 48 months.
Who are they looking for?
This study will recruit 2220 stage 4 or recurrent NSCLC patients with no prior systemic (full body) anticancer therapy. Participants cannot have untreated central nervous system metastasis, an autoimmune disorder, or have any positive test for hepatitis B, hepatitis C, or HIV.
How will it work
Participants will be randomly divided into 4 groups. The first group will receive nivolumab intravenously (through IV into a vein). The second group will receive nivolumab and ipilimumab intravenously. The third group will be administered nivolumab, ipilimumab, and platinum-based chemotherapy (carboplatin, cisplatin, gemcitabine, pemetrexed, paclitaxel) through IV. The last group will only receive the platinum-based chemotherapy.
