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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04870112
Registration number
NCT04870112
Ethics application status
Date submitted
16/04/2021
Date registered
3/05/2021
Titles & IDs
Public title
A Study to Evaluate Subcutaneous Durvalumab in Patients With Non-Small Cell Lung Cancer and Small Cell Lung Cancer
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Scientific title
A Phase 1/2a, Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of Subcutaneous Durvalumab in Patients With Non-Small Cell and Small Cell Lung Cancer - SCope-D1
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Secondary ID [1]
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2020-006041-18
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Secondary ID [2]
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D9072C00001
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Universal Trial Number (UTN)
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Trial acronym
SCope-D1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer
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Small Cell Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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0
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Durvalumab
Treatment: Drugs - Cisplatin
Treatment: Drugs - Carboplatin
Treatment: Drugs - Etoposide
Experimental: Patients with NSCLC - Patients with Non-Small Cell Lung Cancer
Experimental: Patients with SCLC - Patients with Small Cell Lung Cancer
Treatment: Drugs: Durvalumab
Anti-PD-L1 antibody
Treatment: Drugs: Cisplatin
Chemotherapy
Treatment: Drugs: Carboplatin
Chemotherapy
Treatment: Drugs: Etoposide
Chemotherapy
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Observed serum concentration (Ctrough)
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Assessment method [1]
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Timepoint [1]
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Approximately 16 months
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Primary outcome [2]
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Number of patients with injection site reactions and immune-mediated reactions
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Assessment method [2]
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Timepoint [2]
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Approximately 16 months
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Primary outcome [3]
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Maximum observed serum concentration (Cmax)
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Assessment method [3]
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Timepoint [3]
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Approximately 16 months
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Secondary outcome [1]
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Time to maximum observed serum concentration (tmax) of durvalumab
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Assessment method [1]
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Timepoint [1]
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Approximately 16 months
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Secondary outcome [2]
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Area under the Plasma Concentration versus Time Curve (AUCt) of durvalumab
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Assessment method [2]
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Timepoint [2]
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Approximately 16 months
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Secondary outcome [3]
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Incidence of Adverse Events
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Assessment method [3]
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Timepoint [3]
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Approximately 16 months
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Secondary outcome [4]
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Changes in WHO/ECOG performance status
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Assessment method [4]
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Timepoint [4]
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Approximately 16 months
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Secondary outcome [5]
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Occurrence of abnormal ECG - PR, QRS, QT, and QT interval corrected by Fridericia's formula intervals
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Assessment method [5]
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Timepoint [5]
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Approximately 16 months
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Secondary outcome [6]
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Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by abnormality in clinical chemistry
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Assessment method [6]
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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)
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Timepoint [6]
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Approximately 16 months
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Secondary outcome [7]
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Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by abnormality in haematology
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Assessment method [7]
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Hematology will be assessed by white cell count, platelet count, absolute neutrophil count and absolute lymphocyte count.
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Timepoint [7]
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Approximately 16 months
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Secondary outcome [8]
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Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by vital signs (blood pressure in mmHg)
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Assessment method [8]
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Timepoint [8]
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Approximately 16 months
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Secondary outcome [9]
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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
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Assessment method [9]
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Timepoint [9]
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Approximately 16 months
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Secondary outcome [10]
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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
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Assessment method [10]
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Timepoint [10]
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Approximately 16 months
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Secondary outcome [11]
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Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by vital signs (temperature) in degrees Celsius
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Assessment method [11]
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Timepoint [11]
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Approximately 16 months
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Secondary outcome [12]
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Incidence of of anti-drug antibodies (ADA) and neutralizing antibodies
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Assessment method [12]
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Timepoint [12]
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Approximately 16 months
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Secondary outcome [13]
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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
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Assessment method [13]
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Timepoint [13]
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Approximately 16 months
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Secondary outcome [14]
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Part 2 only: Best Objective Response (BoR) - participant's best response following first dose of study drug
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Assessment method [14]
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Timepoint [14]
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Approximately 16 months
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
130
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/06/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/08/2023
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Sample size
Target
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Accrual to date
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Final
18
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Texas
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Country [2]
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United States of America
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State/province [2]
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Virginia
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Country [3]
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New Zealand
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State/province [3]
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Christchurch
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Country [4]
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Spain
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State/province [4]
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Badalona
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Country [5]
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Spain
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State/province [5]
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Majadahonda
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Country [6]
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Taiwan
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State/province [6]
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Taichung
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Country [7]
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Taiwan
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State/province [7]
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Taipei City
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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 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.
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Trial website
https://clinicaltrials.gov/study/NCT04870112
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Suli Bolus, MD
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Address
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AstraZeneca
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
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When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Available to whom?
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04870112