Lung Cancer Clinical Trial

A Study to Evaluate Subcutaneous Durvalumab in Patients With Non-Small Cell Lung Cancer and Small Cell Lung Cancer

Summary

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

124

Study ID:

NCT04870112

Recruitment Status:

Recruiting

Sponsor:

AstraZeneca

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There are 28 Locations for this study

See Locations Near You

Research Site
Tucson Arizona, 85704, United States
Research Site
Tucson Arizona, 85711, United States
Research Site
Augusta Georgia, 30912, United States
Research Site
Lexington Kentucky, 40536, United States
Research Site
Billings Montana, 59101, United States
Research Site
Charlotte North Carolina, 28204, United States
Research Site
Cleveland Ohio, 44109, United States
Research Site
Houston Texas, 77090, United States
Research Site
Fairfax Virginia, 22031, United States
Research Site
Porto Alegre , 90035, Brazil
Research Site
Olomouc , 775 2, Czechia
Research Site
Ostrava - Vitkovice , 703 8, Czechia
Research Site
Praha 5 , CZ-15, Czechia
Research Site
Praha , 140 5, Czechia
Research Site
Praha , 180 8, Czechia
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Christchurch , 8011, New Zealand
Research Site
Singapore , 11922, Singapore
Research Site
Singapore , 16961, Singapore
Research Site
Singapore , 30843, Singapore
Research Site
Badalona , 08916, Spain
Research Site
Madrid , 28041, Spain
Research Site
Majadahonda , 28222, Spain
Research Site
Sevilla , 41009, Spain
Research Site
Taichung , 40705, Taiwan
Research Site
Taipei City , 11217, Taiwan
Research Site
Taipei City , 114, Taiwan
Research Site
Taipei , 235, Taiwan
Research Site
Ankara , 06340, Turkey

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

124

Study ID:

NCT04870112

Recruitment Status:

Recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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