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

Phase 1TerminatedNCT04870112

AstraZeneca18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-Small Cell Lung Cancer Small Cell Lung Cancer

Eligibility

Sex: ALLMin age: 18 YearsMax age: 130 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically or cytologically documented unresectable Stage III NSCLC that has not progressed following definitive platinum based CRT or extensive disease (Stage IV) SCLC * ECOG performance status of 0 or 1 * For participants with SCLC: At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 TL at baseline * Absence of EGFR mutation or ALK rearrangement prior to screening Exclusion Criteria: * History of allogeneic organ transplantation * Autoimmune or inflammatory disorders, diverticulitis, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome * Uncontrolled intercurrent illness * History of another primary malignancy * History of active primary immunodeficiency * Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) * Brain metastases or spinal cord compression * Persistent toxicities (CTCAE Grade \>2) caused by previous anticancer therapy, excluding alopecia * Receipt of live attenuated vaccine within 30 days prior to the first dose of IP

Locations (8)

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