This study is looking to examine the effectiveness of durvalumab (Imfinzi) and consolidation stereotactic body radiation therapy (SBRT) after chemoradiation for locally advanced stage III non-small-cell lung cancer (NSCLC). The main outcomes to be measured are the occurrence of side effects and the survival without cancer worsening. This study is being carried out in Rhode Island, the United States.
The details
NSCLC is a form of lung cancer. It is responsible for 85% of all lung cancer diagnoses worldwide. Durvalumab is a drug that stimulates the immune system to fight lung cancer. Stereotactic body radiation therapy (SBRT) is a new form of radiotherapy that gives fewer but higher radiation doses than standard radiotherapy directly to the tumor, while reducing damage to healthy, surrounding tissues.
This study is being carried out to investigate the effects of the combination of durvalumab with SBRT. in patients with stage III NSCLC. The main outcomes that are to be measured in this trial are the occurrence of side effects and survival without cancer worsening.
Who are they looking for?
The trial is looking to recruit 25 patients with stage III NSCLC. All patients must have completed a course of standard radiation therapy and chemotherapy. Patients must have adequate liver function and blood cell counts, no side effects from previous treatment, and must have an available tumor tissue (biopsy). Patients of reproductive age must agree to use effective birth control during the study and for 6 months after the last treatment of the study.
Patients will not be included if they have disease progression during or after standard chemo-radiotherapy, metastatic disease, prior NSCLC surgery. Patients will also be excluded if they have any uncontrolled illness such as severe heart or liver disease, infections such as HIV, hepatitis B or C, tuberculosis, or other lung conditions. Female patients must not be pregnant or breastfeeding.
How will it work
There is only one group in this trial. All patients will receive durvalumab every 2 weeks for 12 months and 2 fractions of SBRT over 1-2 weeks between the first and second treatments with durvalumab. The first dose of durvalumab will be given between 3 and 7 weeks after the last chemoradiotherapy treatment.
The total follow-up of patients will last for an average of 5 years. The main outcomes measured will be side effects and survival without cancer getting worse.
