drugset / Trial / NCT03237377

Neoadjuvant Immunoradiation for Resectable Non-Small Cell Lung Cancer

NCT03237377 ↗

Non-randomizedSequentialOpen-labelTreatment

Summary

This is a pilot study of neoadjuvant 'immunoradiation' (durvalumab or durvalumab plus tremelimumab) administered every 4 weeks for 2 doses, concurrently with standard thoracic radiation (RT) (45Gy in 25 fractions), with one dose of immunotherapy alone delivered in the pre-surgical window, prior to surgical resection, for patients with stage IIIA NSCLC that is deemed resectable with a lobectomy by a thoracic surgeon. If preliminary safety of the durvalumab/thoracic RT combination is established, a second cohort investigating the combination of durvalumab/tremelimumab/thoracic RT prior to surgical resection will be opened. After surgical resection, patients may receive standard adjuvant chemotherapy, as deemed appropriate by the treating investigator.

Timeline

Start
2017-12-12
Primary completion
2021-11-04
Completion
2024-05-23

Outcome

Outcome not reported

Stopped (Enrollment): “low accrual”

Drugs

EvaluationDrugModalityDoseRoute
Subject Durvalumab Monoclonal antibody 1500 mg Intravenous
Subject Tremelimumab Monoclonal antibody 75 mg Intravenous