This trial is aiming to examine the effectiveness and safety of atezolizumab (Tecentriq) and tiragolumab compared to durvalumab (Imfinzi) in stage III non-small-cell lung cancer (NSCLC) that cannot be surgically removed and has previously been treated with concurrent (at the same time) platinum-based chemoradiation therapy (CRT). The main outcome to be measured in this trial is the length of time patients survive without the progression of the disease.
The details
NSCLC is responsible for 85% of lung cancer diagnoses. The standard treatment for NSCLC involves the surgical removal of tumors, radiotherapy (high dose radiation to kill cancer cells), and chemotherapy. However, some cancers cannot be surgically removed and need new treatments.
Immunotherapy activates the immune system to fight off and kill cancer cells. Atezolizumab is an antibody (immune protein) that is used to treat NSCLC. Tiragolumab is a new immune therapy. Durvalumab is an immune therapy that is used to treat cancer that has spread following treatment with platinum-based chemotherapy.
This trial will compare the safety and effectiveness of atezolizumab and tiragolumab vs durvalumab in patients with stage III NSCLC that has not progressed following CRT. The main outcome to be measured is survival without progression of the disease.
Who are they looking for?
This trial is looking to recruit 800 patients. Patients must have confirmed stage III NSCLC that cannot be surgically removed. Patients must also have had 2 prior treatments with a platinum-based chemotherapy with radiotherapy. Patients will also be included if there has been no spread of the disease following CRT. Female patients must be willing to avoid pregnancy for the duration of this trial and the follow-up period of 5-months. Male participants must be willing to use a barrier form contraception over the duration of this trial and the follow-up period of 5-months.
Patients will be excluded if they have a history of sequential CRT (first one therapy, then the other) for NSCLC, known EGFR mutated (genetic abnormality) cancer, stage IV disease, and NSCLC that has progressed following CRT. Women who are pregnant or breastfeeding are also excluded from this trial. Patients who have long-lasting side effects from previous CRT and other lung medical conditions cannot participate.
How will it work
There are two groups in this trial. The experimental group will receive atezolizumab and tiragolumab over a 4-week cycle. Patients will receive this treatment for a maximum of 13 cycles. The comparison group will receive durvalumab on a 4-week cycle for a maximum of 13 cycles.
The outcomes measured will include survival without cancer worsening, response to treatment, side effects, and overall survival. Follow-up will be up to 90 months following treatment. Outcomes will be measured by the treating physician.
