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
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
How this study is categorized
These labels come from structured fields and exact terms in the public record.
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.
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.