Neoadjuvant Immunoradiation for Resectable Non-Small Cell Lung Cancer

Official Title

Neoadjuvant Immunoradiation for Stage III Resectable Non-Small Cell Lung Cancer

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.

Trial Description

Primary Outcome:

  • Toxicities as measured by number of participants experiencing adverse events
  • Feasibility of Preoperative Immunoradiation
Secondary Outcome:
  • Surgical Morbidity and Mortality
  • Percentage of Participants with Pathologic Response
  • Percentage of Participants with Radiologic Response
  • Duration of Response as measured by recurrence-free survival
  • Overall Survival

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society