This phase 3 trial is examining the effectiveness of durvalumab (Imfinzi) combined with chemotherapy vs chemotherapy alone for stage II and III non-small cell lung cancer (NSCLC) before surgery. The main outcome to be measured will be the major pathological response (mPR; 10 percent or fewer alive cancer cells detectable in the resected tumor following treatment).
The details
A treatment option of patients with NSCLC is surgery to remove the tumor. Chemotherapy is commonly given before surgery to shrink down the tumor or kill cancer cells that have migrated. Durvalumab is an immunotherapy approved for the treatment of NSCLC that cannot be surgically removed. Durvalumab is a type of monoclonal antibody (laboratory-produced molecules engineered to stimulate the immune system to destroy cancer cells). It is not known if durvalumab added to chemotherapy before surgery is more effective than chemotherapy alone in patients with resectable NSCLC.
This study is being done to investigate the use of durvalumab in combination with chemotherapy for NSCLC tumors that can be resected (cut out). The main outcome will be measured by noting the percentage of cancer cells remaining in the tumor after 15 weeks.
Who are they looking for?
300 participants with stage II or III NSCLC that can be surgically removed will be recruited. Patients must not have had previous radiotherapy, or immunotherapy and should have adequate bone marrow and organ function. Patients should also have a genetic sampling of their tumor.
Patients cannot participate if they have a previous or current autoimmune condition, another primary cancer, a history of tuberculosis, hepatitis or HIV or if their cancer cannot be surgically removed.
How will it work
There will be two groups. One group will receive durvalumab with a chemotherapy combination. The other group will receive a placebo (inactive drug) with a chemotherapy combination. They will be followed up in 15 weeks to measure the remaining cancer cells.
After patients will have surgery to remove the tumor, they will be followed up for up to 5.5 years. Survival will also be evaluated.
