A Study to Evaluate Subcutaneous Durvalumab in Patients With Non-Small Cell Lung Cancer and Small Cell Lung Cancer
Stopped early · Phase 1
Conditions studied: Non-Small Cell Lung Cancer, Small Cell Lung Cancer
In brief
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.
Key facts
- Study ID
- NCT04870112
- Run by
- AstraZeneca
- People needed
- 18
- Starts
- 2021-06-28
- Expected to finish
- 2023-08-30
- Last updated by the study team
- 2025-04-17
Who can join
Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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