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NCT04870112 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate Subcutaneous Durvalumab in Patients With Non-Small Cell Lung Cancer and Small Cell Lung Cancer
A Phase 1 study, sponsored by AstraZeneca.
- Terminated
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT04870112 is a Phase 1 study that was terminated before completion, run by AstraZeneca. The registered enrollment target is 18 participants.
The verdict
NCT04870112, a Phase 1 study, was terminated before completion, sponsored by AstraZeneca.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
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.
Interventions
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG Etoposide
- DRUG Durvalumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2021-06-28 |
| Est. Completion | 2023-08-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04870112
The ClinicalTrials.gov registry entry for NCT04870112 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Carboplatin is the first listed.
NCT04870112 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04870112 about?
NCT04870112 is a clinical study titled "A Study to Evaluate Subcutaneous Durvalumab in Patients With Non-Small Cell Lung Cancer and Small Cell Lung Cancer". 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 wit...
What is the current status of trial NCT04870112?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2021-06-28. Estimated completion is 2023-08-30.
What interventions are being tested in trial NCT04870112?
The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Etoposide (DRUG), Durvalumab (DRUG).
Who is sponsoring clinical trial NCT04870112?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
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