About the study

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.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

1. Histologically or cytologically documented unresectable Stage III NSCLC that has not progressed following definitive platinum based CRT or extensive disease (Stage IV) SCLC
2. ECOG performance status of 0 or 1
3. For participants with SCLC: At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 TL at baseline
4. Absence of EGFR mutation or ALK rearrangement prior to screening

Exclusion criteria

1. History of allogeneic organ transplantation
2. Autoimmune or inflammatory disorders, diverticulitis, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome
3. Uncontrolled intercurrent illness
4. History of another primary malignancy
5. History of active primary immunodeficiency
6. Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
7. Brain metastases or spinal cord compression
8. Persistent toxicities (CTCAE Grade >2) caused by previous anticancer therapy, excluding alopecia
9. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.