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

NCT04870112 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-04-17

No results posted yet for this study

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.

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.

Conditions

Interventions

DRUG

Durvalumab

Anti-PD-L1 antibody

DRUG

Cisplatin

Chemotherapy

DRUG

Carboplatin

Chemotherapy

DRUG

Etoposide

Chemotherapy

Sponsors & Collaborators

Principal Investigators

  • Suli Bolus, MD · AstraZeneca

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-28
Primary Completion
2023-08-30
Completion
2023-08-30
FDA Drug
Yes

Countries

  • United States
  • New Zealand
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04870112 on ClinicalTrials.gov