A Study to Evaluate Subcutaneous Durvalumab in Patients With Non-Small Cell Lung Cancer and Small Cell Lung Cancer
Status:
Recruiting
Trial end date:
2024-01-19
Target enrollment:
Participant gender:
Summary
This study has 2 parts: dose finding and dose confirmatory.
In Part 1, the dose finding phase of the study, there will be 3 or more dosing levels to find
out what dose of durvalumab administered as an infusion under the skin acts similarly to
durvalumab administered into a vein. 24 participants with Non-Small Cell Lung Cancer will be
enrolled for a 12 month treatment period and 3 months follow up.
In Part 2, the dose confirmation phase of the study, participants will receive the dose of
durvalumab identified in Part 1 of the study. The goal of Part 2 will be to learn more about
the way that the body processes durvalumab when administered as an infusion under the skin.
Approximately 90 participants with Non-Small Cell Lung Cancer will be enrolled; additionally,
up to 10 participants with Small Cell Lung Cancer (who will receive concurrent chemotherapy)
will be enrolled for a 12 treatment period and a 3 month follow-up period.