Lung Cancer Clinical Trial
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.
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
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
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There are 8 Locations for this study
Houston Texas, 77090, United States
Fairfax Virginia, 22031, United States
Christchurch , 8011, New Zealand
Badalona , 08916, Spain
Majadahonda , 28222, Spain
Taichung , 40705, Taiwan
Taipei City , 11217, Taiwan
Taipei City , 114, Taiwan
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