This trial is being carried out to assess the effectiveness of atezolizumab (Tecentriq) in combination with cabozantinib (Cabometyx) versus docetaxel (Taxotere) in patients with metastatic non-small cell lung cancer (NSCLC) which has previously been treated with immunotherapy and platinum-based chemotherapy. The main outcome will be measured is the overall survival (OS) of patients.
NSCLC is responsible for 85% of all lung cancer diagnoses worldwide. It remains difficult to treat if it becomes metastatic (spread from the original tumor site). For these patients, new treatments are needed. Atezolizumab is a cancer immune therapy. It stimulates the immune system to attack and kill cancer cells. Cabozantinib is a targeted therapy that blocks growing signals for cancer cells. This leads to cancer cell death. Docetaxel is a chemotherapy medication that is used in the treatment of NSCLC.
This study is comparing the effectiveness of atezolizumab with cabozantinib compared to docetaxel-only therapy. The main outcome that is to be measure during this trial is the survival of patients.
Who are they looking for?
This study is looking to recruit 350 patients with metastatic NSCLC. Patients must have disease worsening following platinum-based chemotherapy and immunotherapy and must have recovered from any side effects from previous therapy. Participants must have adequate organ function and those of childbearing age or with partners of childbearing age must agree to use effective birth control.
Patients will be excluded from this trial if they had prior therapy with cabozantinib, docetaxel, or a combination of immunotherapies. Patients with hepatitis, HIV, cancer spread to the brain or another cancer will not be included. Patients with uncontrolled heart, lung, or liver disease will also be excluded. Female patients who are pregnant, want to become pregnant or breastfeeding are also excluded from this trial.
How will it work
There are two groups in this trial. The first group will receive atezolizumab and cabozantinib over the course of 21-day cycles. The comparison group will receive docetaxel on day 1 of a 21-day cycle. Cabozantinib will be given as tablets, while atezolizumab and docetaxel are administered through an intravenous infusion.
Patients will be followed up for up to 43 months. Overall survival, survival without cancer worsening, overall response to treatment, and side effects will be the main objectives.