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A Phase 1/2a, Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of Subcutaneous Durvalumab in Patients With Non-Small Cell and Small Cell Lung Cancer - SCope-D1
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. AstraZeneca has decided to stop further enrollment and the study was terminated when all patients in Part 1 (Phase I) completed their last study visit. No safety issues or clinical concerns however, have been identified for this study. Part 2 (Phase II) was not initiated.
Age
18 - 130 years
Sex
ALL
Healthy Volunteers
No
Research Site
Houston, Texas, United States
Research Site
Fairfax, Virginia, United States
Research Site
Christchurch, New Zealand
Research Site
Badalona, Spain
Research Site
Majadahonda, Spain
Research Site
Taichung, Taiwan
Research Site
Taipei, Taiwan
Research Site
Taipei, Taiwan
Start Date
June 28, 2021
Primary Completion Date
August 30, 2023
Completion Date
August 30, 2023
Last Updated
April 17, 2025
18
ACTUAL participants
Durvalumab
DRUG
Cisplatin
DRUG
Carboplatin
DRUG
Etoposide
DRUG
Lead Sponsor
AstraZeneca
NCT07190248
NCT07485114
Data Source & Attribution
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