Status:
TERMINATED
A Study to Evaluate Subcutaneous Durvalumab in Patients With Non-Small Cell Lung Cancer and Small Cell Lung Cancer
Lead Sponsor:
AstraZeneca
Conditions:
Non-Small Cell Lung Cancer
Small Cell Lung Cancer
Eligibility:
All Genders
18-130 years
Phase:
PHASE1
Brief 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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2023
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04870112
Start Date
June 28 2021
End Date
August 30 2023
Last Update
April 17 2025
Active Locations (8)
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1
Research Site
Houston, Texas, United States, 77090
2
Research Site
Fairfax, Virginia, United States, 22031
3
Research Site
Christchurch, New Zealand, 8011
4
Research Site
Badalona, Spain, 08916