A multicentre, Phase II, single-arm, interventional study of neoadjuvant durvalumab and platinum-based chemotherapy (CT), followed by either surgery and adjuvant durvalumab or chemoradiotherapy (CRT) and consolidation durvalumab, in participants with resectable or borderline resectable stage IIB-IIIB Non-small Cell Lung Cancer (NSCLC)

The University of Virginia Comprehensive Cancer Center seeks participants ages 18 and over with resectable or borderline resectable (Stage IIB to IIIB) non-small cell lung cancer (NSCLC). “Resectable” means that your tumor can be completely removed through surgery. In this study, you will undergo evaluation by lung cancer specialists including a medical oncologist and thoracic surgeon. If you meet the study requirements, you will be invited to take part in the study. The study drug (durvalumab) as well as the standard of care (SoC) chemotherapy will be administered via infusion (into the blood vessel through a plastic tube and needle over a period of time). Durvalumab is approved by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of patients with unresectable locally advanced NSCLC after receiving chemoradiation therapy. It is not certain that you will directly benefit from the participation in the study. Your participation may, however, help other patients in the future by improving the knowledge of diseases and improving medical care.
You will initially receive 2 cycles of SoC chemotherapy + durvalumab every 3 weeks. Your team will then repeat scans (CT or PET) to check progress with treatment, and determine if surgery is possible. If it is not, treatment will change to chemoradiotherapy. If surgery can be done, you will get 1-2 more cycles of SoC chemotherapy + durvalumab every 3 weeks and then have surgery. After surgery or radiation is completed, you will get Durvalumab for 12 months, given once every 4 weeks. Durvalumab is a type of anticancer drug called immunotherapy that targets cancer cells by blocking the signal that prevents the immune system from seeing the cancer cell.
If you are enrolled in treatment, you may need to have the following exams, tests, and procedures:
• Physical exam
• Vital signs
• Blood collection
• Blood sampling
• Urine sampling
• Electrocardiogram (ECG)
• Pregnancy test
• Safety monitoring

You will be in the study for approximately 3 years. You will have about 28 study visits (resectable tumors with surgery) or up to 57 study visits

Additional information found here: https://www.clinicaltrials.gov/study/NCT05925530?titles=MDT%20Bridge&ra…

For questions, contact:
uvacancertrials@hscmail.mcc.virginia.edu