TerminatedPhase 1NCT04870112

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 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.

Checked against the public recordLast updated Apr 17, 2025 · Source: ClinicalTrials.gov

StatusTerminated
PhasePhase 1
U.S. locations8
SponsorAstraZeneca
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
AstraZeneca
Interventions being studied
Drug: Durvalumab; Drug: Cisplatin; Drug: Carboplatin; Drug: Etoposide
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Research SiteHouston, Texas
  • Research SiteFairfax, Virginia
  • Research SiteChristchurch
  • Research SiteBadalona
  • Research SiteMajadahonda
  • Research SiteTaichung
  • Research SiteTaipei
  • Research SiteTaipei

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 17, 2025. Always confirm current availability with the study team.

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