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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04870112
Other study ID # D9072C00001
Secondary ID 2020-006041-18
Status Terminated
Phase Phase 1
First received
Last updated
Start date June 28, 2021
Est. completion date August 30, 2023

Study information

Verified date February 2024
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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. 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.


Recruitment information / eligibility

Status Terminated
Enrollment 18
Est. completion date August 30, 2023
Est. primary completion date August 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 130 Years
Eligibility 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 Design


Intervention

Drug:
Durvalumab
Anti-PD-L1 antibody
Cisplatin
Chemotherapy
Carboplatin
Chemotherapy
Etoposide
Chemotherapy

Locations

Country Name City State
New Zealand Research Site Christchurch
Spain Research Site Badalona
Spain Research Site Majadahonda
Taiwan Research Site Taichung
Taiwan Research Site Taipei City
Taiwan Research Site Taipei City
United States Research Site Fairfax Virginia
United States Research Site Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  New Zealand,  Spain,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Other Incidence of injection site reactions reported through ISQ Symptoms questionnaire Approximately 16 months
Other Treatment satisfaction reported using ISQ Satisfaction questionnaire Approximately 16 months
Primary Observed serum concentration (Ctrough) Approximately 16 months
Primary Number of patients with injection site reactions and immune-mediated reactions Approximately 16 months
Primary Maximum observed serum concentration (Cmax) Approximately 16 months
Secondary Time to maximum observed serum concentration (tmax) of durvalumab Approximately 16 months
Secondary Area under the Plasma Concentration versus Time Curve (AUCt) of durvalumab Approximately 16 months
Secondary Incidence of Adverse Events Approximately 16 months
Secondary Changes in WHO/ECOG performance status Approximately 16 months
Secondary Occurrence of abnormal ECG - PR, QRS, QT, and QT interval corrected by Fridericia's formula intervals Approximately 16 months
Secondary Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by abnormality in clinical chemistry Clinical chemistry will be assessed by liver function(Alanine aminotransferase, Aspartate aminotransferase, albumin, total bilirubin), kidney function (e.g. Urea, Creatinine) and endocrine function(TSH, T3 free,T4 free) Approximately 16 months
Secondary Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by abnormality in haematology Hematology will be assessed by white cell count, platelet count, absolute neutrophil count and absolute lymphocyte count. Approximately 16 months
Secondary Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by vital signs (blood pressure in mmHg) Approximately 16 months
Secondary Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by vital signs (pulse rate) in beats per minute Approximately 16 months
Secondary Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by vital signs (respiration rate) in breaths per minute Approximately 16 months
Secondary Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by vital signs (temperature) in degrees Celsius Approximately 16 months
Secondary Incidence of of anti-drug antibodies (ADA) and neutralizing antibodies Approximately 16 months
Secondary Part 2 only: Overall Response Rate (ORR) - proportion of participants with a complete or partial response to treatment as determined using RECIST 1.1 guidelines Approximately 16 months
Secondary Part 2 only: Best Objective Response (BoR) - participant's best response following first dose of study drug Approximately 16 months
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