A Study to Evaluate Subcutaneous Durvalumab in Patients With Non-Small Cell Lung Cancer and Small Cell Lung Cancer

Part of paid clinical trials in Houston, Texas.

Sponsor: AstraZeneca
Study ID: NCT04870112
Phase: PHASE1
Status: Terminated

Conditions

Eligibility Criteria

Sex: ALL
Age: 18 Years - 130 Years
Healthy Volunteers: Not accepted

Interventions

Durvalumab — DRUG
Anti-PD-L1 antibody
Cisplatin — DRUG
Chemotherapy
Carboplatin — DRUG
Chemotherapy
Etoposide — DRUG
Chemotherapy

Study Details

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.